Calibration Support System, Calibration Support Method, Calibration Support Program

Abstract

Facilitate the correction of document data. 【Solution means】 The correction support system includes a control unit and an output unit. The control unit performs an image acquisition step of obtaining a loaded image including the correction target area by loading or scanning document data having a plurality of correction target areas, a character recognition step of recognizing characters from the loaded image, and a description defect identification step of identifying description defects in the correction target area based on the characters recognized in the character recognition step and a database including predetermined description conditions, and an output step of causing the output unit to display a first display area, a second display area, and a third display area side by side. The first display area has the loaded image. The second display area has a character string composed of the characters recognized in the character recognition step, and the third display area has information regarding the description defects.

Description

Technical Field

[0001] The present invention relates to a calibration support system and the like.

Background Art

[0002] Conventionally, as in Patent Document 1, a system for identifying deficiencies in document data has been disclosed.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] However, the identification of deficiencies based on comparison with an external database was not sufficient.

[0005] Therefore, an object of the present invention is to facilitate the calibration of document data.

Means for Solving the Problems

[0006] The calibration support system according to the present invention includes a control unit and an output unit. The control unit executes an image acquisition step of obtaining a loaded image including the calibration target area by loading or scanning document data having a plurality of calibration target areas, a character recognition step of recognizing characters from the loaded image, a deficiency identification step of identifying deficiencies in the calibration target area based on the characters recognized in the character recognition step and a database including predetermined description conditions, and an output step of causing the output unit to display a first display area, a second display area, and a third display area side by side. The first display area has the loaded image. The second display area has a character string composed of the characters recognized in the character recognition step. The third display area has information regarding the deficiencies in the description.

[0007] Regarding documents such as the comprehensive product information summary of pharmaceuticals, which have a large number of characters and many description conditions, it is possible to recognize characters from the loaded image and identify deficiencies in the description that do not meet the description conditions from the recognized characters, making it easy to correct the document data.

[0008] The loaded image, the character string composed of the recognized characters, and the information regarding the deficiencies in the description can be displayed side by side, making it easy to correct the document data. In particular, since the character string composed of the recognized characters is displayed in the second display area, it is easy to distinguish between errors such as character garbling when recognizing characters and character recognition errors, and the true deficiencies in the loaded image.

[0009] Preferably, the description condition is that the first character string is not used in all or the first area of the plurality of areas to be corrected. In the step of identifying the deficiencies in the description, when the deficiencies are identified assuming that the first character string is used in all or the first area, the first display area has an area including the first character string in the loaded image, the second display area has a character string including the first character string in the document data, and the third display area has information regarding the deficiencies including the first character string.

[0010] It is easy to visually recognize a state where the first character string, which is prohibited from being used under the description conditions, is erroneously used.

[0011] Also, preferably, the description condition is that when the second character string is used in the second area of the plurality of areas to be corrected, the third character string is used in the second area. In the step of identifying the deficiency in the description, when the deficiency in the description is identified on the assumption that the second character string is used in the second area and the third character string is not used in the second area, the first display area has the second area in the read image, the second display area has a character string including the second area in the document data, and the third display area has information regarding the deficiency in the description including the third character string.

[0012] It is possible to easily visually recognize a state in which the third character string that must be used under the description conditions is not used incorrectly.

[0013] Also, preferably, when the second character string is used in the second area of the plurality of areas to be calibrated, the description condition is that the second character Column or the third character string is used in a third area different from the second area. In the step of identifying the deficiency in the description, when the deficiency in the description is identified on the assumption that the second character string is used in the second area and the second character Column or the third character string is not used in the third area, the first display area has the third area in the read image, the second display area has a character string including the third area in the document data, and the third display area has information regarding the deficiency in the description including the second character string or the third character string.

[0014] It is possible to easily visually recognize a state in which the second character string that must be used under the description conditions is not used incorrectly.

[0015] Also, preferably, in the second display area, among the character strings composed of the characters recognized in the character recognition step, the first part regarding the deficiency in the description is displayed in an emphasized state in a method different from that of the second part regarding the deficiency in the description. In the third display area, the area corresponding to the first part among the information regarding the deficiency in the description is displayed in an emphasized state in the same method as that of the first part. In the third display area, the area corresponding to the second part is displayed in an emphasized state in the same manner as the second part.

[0016] Compared with the form of highlighting the places identified as incomplete descriptions in the first display area, highlighting can be performed easily and accurately. Differences between parts related to a plurality of incomplete descriptions can be easily visually recognized.

[0017] In the calibration support method executed by the control unit in the calibration support system according to the present invention, which includes a control unit and an output unit, an image acquisition step of obtaining a loaded image including the calibration target area by loading or scanning document data having a plurality of calibration target areas, a character recognition step of recognizing characters from the loaded image, An incomplete description specifying step of specifying incomplete descriptions in the calibration target area based on the characters recognized in the character recognition step and a database including predetermined description conditions, and an output step of causing the output unit to display a first display area, a second display area, and a third display area side by side are executed. The first display area has the loaded image. The second display area has a character string composed of the characters recognized in the character recognition step. The third display area has information related to the incomplete description.

[0018] In the calibration support program executed by the control unit in the calibration support system according to the present invention, which includes a control unit and an output unit, an image acquisition step of obtaining a loaded image including the calibration target area by loading or scanning document data having a plurality of calibration target areas, a character recognition step of recognizing characters from the loaded image, an incomplete description specifying step of specifying incomplete descriptions in the calibration target area based on the characters recognized in the character recognition step and a database including predetermined description conditions, and an output step of causing the output unit to display a first display area, a second display area, and a third display area side by side are executed. The first display area has the loaded image. The second display area has a character string composed of the characters recognized in the character recognition step. The third display area has information regarding the deficiencies in the description.

Effect of the Invention

[0019] According to the present invention as described above, the correction of document data can be facilitated.

Brief Description of the Drawings

[0020]

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Embodiments for Carrying Out the Invention

[0021] Hereinafter, this embodiment will be described with reference to the drawings. Note that the embodiments are not limited to the following embodiments. In principle, the content described in one embodiment is also applicable to other embodiments. In addition, each embodiment and each modification can be combined as appropriate.

[0022] (Calibration Support System 1) The calibration support system 1 in this embodiment includes an information server 10 and a user terminal 30 (see Fig. 1). The calibration support system 1 determines whether the document data 100 meets the description conditions recorded in the database D1, and causes the determination result to be displayed on the user-side output unit 37.

[0023] (Information Server 10) The information server 10 includes a server communication unit 11, a server recording unit 13, and a server control unit 15.

[0024] (Server Communication Unit 11) The server communication unit 11 communicates with the user-side communication unit 31 of the user terminal 30 via a network.

[0025] (Server Recording Unit 13) The server recording unit 13 records the database D1.

[0026] (Server Control Unit 15) The server control unit 15 controls each part of the information server 10.

[0027] (Database D1) The content of the database D1 is input via an input device (not shown) provided in the information server 10, or via an input device (not shown) of an administrator terminal connected to the information server 10. When the database D1 is updated, the server control unit 15 transmits information regarding the update of the database D1 to the user terminal 30. The configuration of the database D1 will be described later.

[0028] (User Terminal 30) The user terminal 30 includes a user-side communication unit 31, a user-side recording unit 33, a user-side control unit 35, a user-side input unit 36, and a user-side output unit 37.

[0029] (User-side communication unit 31) The user-side communication unit 31 communicates with the server communication unit 11 of the information server 10 via a network, either wired or wirelessly.

[0030] (User-side recording unit 33) The user-side recording unit 33 records the database D1. In addition, the calibration support program of this embodiment is installed in the user-side recording unit 33.

[0031] (User-side control unit 35) The user-side control unit 35 controls each part of the user terminal 30. The user-side control unit 35 executes the calibration support program. The calibration support program includes an image acquisition step, a region identification step, an optical character recognition step, a description deficiency identification step, and an output step. Details of each step will be described later.

[0032] (User-side input unit 36) The user-side input unit 36 is used to perform manual operations on the calibration support program (such as selecting document data 100 to be loaded or scanned). The user-side input unit 36 may be composed of a touch panel provided on the user-side output unit 37, or may be composed of physical keys separate from the user-side output unit 37.

[0033] (User-side output unit 37) The user-side output unit 37 displays a calibration support screen P1 (see FIGS. 17 to 25). Details of the composition support screen P1 will be described later.

[0034] (Document data 100) The document data 100 to be calibrated by the calibration support system 1 in this embodiment is a comprehensive product information summary of a pharmaceutical product (product name: ○×○×), and has a plurality of calibration target areas including at least one of a heading and a body text. In this embodiment, as an example of the document data 100, an example including the following parts, chapters, sections, subsections, and paragraphs is shown, but the configuration of the document data 100 is not limited to this, and the number of parts and the like is not limited to those shown below. The document data 100 has the 1st part Pa01 to the 14th part Pa14 (see FIGS. 2 to 13). Note that the cover and table of contents of the comprehensive product information summary may be included in a part of the 1st part Pa01, or the back cover of the comprehensive product information summary may be included in a part of the 14th part Pa14.

[0035] The character strings “XXX” and “YYY” in the comprehensive product information summary are examples of disease names. The character string “○×○×” is an example of the product name of a pharmaceutical product. The character string “Compound A” is an example of a compound name. The character strings “●mg”, “△mg”, and “■mg” are examples of the dosage of administering the pharmaceutical product (product name: ○×○×). The character strings “★week” and “☆week” are examples of time in weeks. The character string “ZZZ” is an example of an index for evaluating the degree of improvement of a predetermined disease “XXX”. The character string “WWW” is an example of a target for disease control. The character strings “○○”, “××”, and “△△” are examples of the product names of other companies.

[0036] (1st part Pa01) The 1st part Pa01 is composed of a calibration target area including the 1st heading a1 and the 1st body text b1 (see FIG. 2). The 1st heading a1 of the 1st part Pa01 includes the character string “History of Development”. The 1st body text b1 of the 1st part Pa01 includes at least one of character information and graphic information related to the character string “History of Development”.

[0037] (Second Part Pa02) The second part Pa02 is composed of an area to be corrected including a first heading a1 and a first body text b1 (see Fig. 3). The first heading a1 of the second part Pa02 contains the character string "Product Characteristics". The first body text b1 of the second part Pa02 contains at least one of character information and graphic information regarding the character string "Product Characteristics". The first body text b1 of the second part Pa02 has Chapters 1 to 10 of the first chapter Ch01~Ch10.

[0038] (Chapter 1 Ch01 of the second part Pa02) Chapter 1 Ch01 of the second part Pa02 is composed of an area to be corrected including a second heading a2 and a second body text b2. The second heading a2 of Chapter 1 Ch01 of the second part Pa02 contains the character string "Characteristics of ○×○× as a therapeutic agent for disease XXX". The second body text b2 of Chapter 1 Ch01 of the second part Pa02 contains at least one of character information and graphic information regarding the character string "Characteristics of ○×○× as a therapeutic agent for disease XXX".

[0039] (Chapter 2 Ch02 of the second part Pa02) Chapter 2 Ch02 of the second part Pa02 is composed of an area to be corrected including a second heading a2 and a second body text b2. The second heading a2 of Chapter 2 Ch02 of the second part Pa02 contains the character string "Characteristics of ○×○× as a therapeutic agent for disease YYY". The second body text b2 of Chapter 2 Ch02 of the second part Pa02 contains at least one of character information and graphic information regarding the character string "Characteristics of ○×○× as a therapeutic agent for disease YYY".

[0040] (Chapters 3 to 10 Ch03~Ch10 of the second part Pa02) Each of Chapters 3 to 10 Ch03~Ch10 of the second part Pa02 is composed of an area to be corrected including a heading and a body text (not shown).

[0041] (Part 3 Pa03) Part 3 Pa03 is composed of a correction target area including a first heading a1 and a first text b1 (see Figure 4). The first heading a1 of Part 3 Pa03 includes the character string "Product Information (Drug Information)". The first text b1 of Part 3 Pa03 includes at least one of character information and graphic information regarding the character string "Product Information (Drug Information)". The first text b1 of Part 3 Pa03 has Chapters 1 to 16 (Ch01 to Ch16).

[0042] (Chapter 1 Ch01 of Part 3 Pa03) Chapter 1 Ch01 of Part 3 Pa03 is composed of a correction target area including a second heading a2 and a second text b2. The second heading a2 of Chapter 1 Ch01 of Part 3 Pa03 includes the character string "Warning". The second text b2 of Chapter 1 Ch01 of Part 3 Pa03 includes at least one of character information and graphic information regarding the character string "Warning".

[0043] (Chapter 2 Ch02 of Part 3 Pa03) Chapter 2 Ch02 of Part 3 Pa03 is composed of a correction target area including a second heading a2 and a second text b2. The second heading a2 of Chapter 2 Ch02 of Part 3 Pa03 includes the character string "Taboo". The second text b2 of Chapter 2 Ch02 of Part 3 Pa03 includes at least one of character information and graphic information regarding the character string "Taboo".

[0044] (Chapter 3 Ch03 of Part 3 Pa03) Chapter 3 Ch03 of Part 3 Pa03 is composed of a correction target area including a second heading a2 and a second text b2. The second heading a2 of the third chapter Ch03 of the third part Pa03 contains the character string "Composition and Properties". The second main text b2 of the third chapter Ch03 of the third part Pa03 contains at least one of character information and graphic information regarding the character string "Composition and Properties".

[0045] (The fourth chapter Ch04 of the third part Pa03) The fourth chapter Ch04 of the third part Pa03 is composed of a proofreading target area including the second heading a2 and the second main text b2. The second heading a2 of the fourth chapter Ch04 of the third part Pa03 contains the character string "Efficacy or Effect". The second main text b2 of the fourth chapter Ch04 of the third part Pa03 contains at least one of character information and graphic information regarding the character string "Efficacy or Effect".

[0046] (The fifth chapter Ch05 to the eighth chapter Ch08 of the third part Pa03) Each of the fifth chapter Ch05 to the eighth chapter Ch08 of the third part Pa03 is composed of a proofreading target area including a heading and a main text (not shown).

[0047] (The ninth chapter Ch09 of the third part Pa03) The ninth chapter Ch09 of the third part Pa03 is composed of a proofreading target area including the second heading a2 and the second main text b2 (see Figure 5). The second heading a2 of the ninth chapter Ch09 of the third part Pa03 contains the character string "Precautions Regarding Patients with a Specific Background". The second main text b2 of the ninth chapter Ch09 of the third part Pa03 contains at least one of character information and graphic information regarding the character string "Precautions Regarding Patients with a Specific Background".

[0048] (The tenth chapter Ch10 of the third part Pa03) The tenth chapter Ch10 of the third part Pa03 is composed of a proofreading target area including the second heading a2 and the second main text b2. The second heading a2 of the 10th chapter Ch10 of the 3rd part Pa03 contains the string "Interaction". The second body text b2 of the 10th chapter Ch10 of the 3rd part Pa03 contains at least one of character information and graphic information regarding the string "Interaction".

[0049] (Chapters 11 to 16 of the 3rd part Pa03) Each of Chapters 11 to 16 of the 3rd part Pa03 is composed of a proofreading target area including a heading and a body text (not shown).

[0050] (4th part Pa04) The 4th part Pa04 is composed of a proofreading target area including a first heading a1 and a first body text b1 (see Fig. 6). The first heading a1 of the 4th part Pa04 contains the string "Clinical Outcome". The first body text b1 of the 4th part Pa04 contains at least one of character information and graphic information regarding the string "Clinical Outcome". The first body text b1 of the 4th part Pa04 has Chapters 1 to 7.

[0051] (Chapter 1 of the 4th part Pa04) Chapter 1 of the 4th part Pa04 is composed of a proofreading target area including a second heading a2 and a second body text b2. The second heading a2 of Chapter 1 of the 4th part Pa04 contains the string "Disease XXX". The second body text b2 of Chapter 1 of the 4th part Pa04 contains at least one of character information and graphic information regarding the string "Disease XXX". The second body text b2 of Chapter 1 of the 4th part Pa04 has Sections 1 to 6.

[0052] (Section 1 of Chapter 1 of the 4th part Pa04) The first section Se01 of the first chapter Ch01 of the fourth part Pa04 consists of a calibration target area including a third heading a3 and a third body text b3. The third heading a3 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 includes the character string "Domestic Trial: Phase 2b / 3 Randomized Double-Blind Comparative Trial". The third body text b3 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 includes at least one of character information and graphic information regarding the character string "Domestic Trial: Phase 2b / 3 Randomized Double-Blind Comparative Trial". The third body text b3 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 has a first sub-section Su01 to a fourth sub-section Su04.

[0053] (The first sub-section Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04) The first sub-section Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 consists of a calibration target area including a fourth heading a4 and a fourth body text b4. The fourth heading a4 of the first sub-section Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 includes the character string "Test Summary". The fourth body text b4 of the first sub-section Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 includes at least one of character information and graphic information regarding the character string "Test Summary". The fourth body text b4 of the first sub-section Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 has a first paragraph Pr01 to a sixth paragraph Pr06.

[0054] (The first paragraph Pr01 of the first sub-section Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04) The first paragraph Pr01 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 consists of a correction target area including a fifth heading a5 and a fifth body text a5. The fifth heading a5 of the first paragraph Pr01 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains the character string "Purpose". The fifth body text b5 of the first paragraph Pr01 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information related to the character string "Purpose".

[0055] (The second paragraph Pr02 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04) The second paragraph Pr02 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 consists of a correction target area including a fifth heading a5 and a fifth body text a5. The fifth heading a5 of the second paragraph Pr02 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains the character string "Target". The fifth body text b5 of the second paragraph Pr02 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information related to the character string "Target".

[0056] (The third paragraph Pr03 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04) The third paragraph Pr03 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 consists of a correction target area including a fifth heading a5 and a fifth body text a5. The fifth heading a5 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains the string "Design". The fifth text b5 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information regarding the string "Design".

[0057] (The fourth paragraph Pr04 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04) The fourth paragraph Pr04 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 is composed of a correction target area including the fifth heading a5 and the fifth text a5. The fifth heading a5 of the fourth paragraph Pr04 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains the string "Method". The fifth text b5 of the fourth paragraph Pr04 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information regarding the string "Method".

[0058] (The fifth paragraph Pr05 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04) The fifth paragraph Pr05 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 is composed of a correction target area including the fifth heading a5 and the fifth text a5. The fifth heading a5 of the fifth paragraph Pr05 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains the string "Evaluation Items". The fifth sentence Pr05 of the fifth paragraph Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains at least one of the character information and graphic information regarding the character string "evaluation item".

[0059] (The sixth paragraph Pr06 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04) The sixth paragraph Pr06 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 is composed of a calibration target area including a fifth heading a5 and a fifth main text a5. The fifth heading a5 of the sixth paragraph Pr06 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains the character string "analysis plan". The fifth main text b5 of the sixth paragraph Pr06 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains at least one of the character information and graphic information regarding the character string "analysis plan".

[0060] (The second subsection Su02 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04) The second subsection Su02 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 is composed of a calibration target area including a fourth heading a4 and a fourth main text b4. The fourth heading a4 of the second subsection Su02 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains the character string "Patient Background (FAS)". The fourth main text b4 of the second subsection Su02 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains at least one of the character information and graphic information regarding the character string "Patient Background (FAS)".

[0061] (The third subsection Su03 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04) The third sub-section Su03 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 consists of a correction target area including a fourth heading a4 and a fourth text b4 (see Figure 7). The fourth heading a4 of the third sub-section Su03 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 includes the character string "Effectiveness Evaluation". The fourth text b4 of the third sub-section Su03 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 includes at least one of character information and graphic information regarding the character string "Effectiveness Evaluation".

[0062] (The fourth sub-section Su04 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04) The fourth sub-section Su04 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 consists of a correction target area including a heading and a text (not shown).

[0063] (The second section Se02 of the first chapter Ch01 of the fourth part Pa04) The second section Se02 of the first chapter Ch01 of the fourth part Pa04 consists of a correction target area including a third heading a3 and a third text b3 (see Figure 8). The third heading a3 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 includes the character string "Overseas Trial: Phase 3 Randomized Double-Blind Comparative Trial (Overseas Data)". The third text b3 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 includes at least one of character information and graphic information regarding the character string "Overseas Trial: Phase 3 Randomized Double-Blind Comparative Trial (Overseas Data)". The third text b3 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 has the first sub-section Su01 to the fourth sub-section Su04.

[0064] (The first sub-section Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04) The first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 consists of a calibration target area that includes the fourth heading a4 and the fourth text b4. The fourth heading a4 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 contains the character string "Test Summary". The fourth text b4 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 includes at least one of character information and graphic information related to the character string "Test Summary". The fourth text b4 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 has the first paragraph Pr01 to the sixth paragraph Pr06.

[0065] (The first paragraph Pr01 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04) The first paragraph Pr01 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 consists of a calibration target area that includes the fifth heading a5 and the fifth text a5. The fifth heading a5 of the first paragraph Pr01 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 contains the character string "Purpose". The fifth text b5 of the first paragraph Pr01 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 includes at least one of character information and graphic information related to the character string "Purpose".

[0066] (The second paragraph Pr02 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04) The second paragraph Pr02 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 consists of a calibration target area that includes the fifth heading a5 and the fifth text a5. The fifth heading a5 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 contains the string "target". The fifth text b5 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information regarding the string "target".

[0067] (The third paragraph Pr03 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04) The third paragraph Pr03 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 is composed of a calibration target area including the fifth heading a5 and the fifth text a5. The fifth heading a5 of the third paragraph Pr03 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 contains the string "design". The fifth text b5 of the third paragraph Pr03 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information regarding the string "design".

[0068] (The fourth paragraph Pr04 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04) The fourth paragraph Pr04 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 is composed of a calibration target area including the fifth heading a5 and the fifth text a5. The fifth heading a5 of the fourth paragraph Pr04 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 contains the string "method". The fifth sentence b5 of the fourth paragraph Pr04 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information regarding the character string "method".

[0069] (The fifth paragraph Pr05 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04) The fifth paragraph Pr05 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 is composed of a calibration target area including a fifth heading a5 and a fifth text body a5. The fifth heading a5 of the fifth paragraph Pr05 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 contains the character string "Evaluation Items". The fifth text body b5 of the fifth paragraph Pr05 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information regarding the character string "Evaluation Items".

[0070] (The sixth paragraph Pr06 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04) The sixth paragraph Pr06 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 is composed of a calibration target area including a fifth heading a5 and a fifth text body a5. The fifth heading a5 of the sixth paragraph Pr06 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 contains the character string "Analysis Plan". The fifth text body b5 of the sixth paragraph Pr06 of the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information regarding the character string "Analysis Plan".

[0071] (Chapter 1, Section 2, Subsection 2 of Part 4 Pa04) Chapter 1, Section 2, Subsection 2 of Part 4 Pa04 is composed of a calibration target area including a fourth heading a4 and a fourth text b4. The fourth heading a4 of Chapter 1, Section 2, Subsection 2 of Part 4 Pa04 includes the character string "Patient Background (FAS)". The fourth text b4 of Chapter 1, Section 2, Subsection 2 of Part 4 Pa04 includes at least one of character information and graphic information regarding the character string "Patient Background (FAS)".

[0072] (Chapter 1, Section 2, Subsection 3 - Subsection 4 of Part 4 Pa04) Each of Subsection 3 Su03 - Subsection 4 Su04 of Chapter 1, Section 2 of Part 4 Pa04 is composed of a calibration target area including a heading and a text (not shown).

[0073] (Chapter 1, Section 3 of Part 4 Pa04) Chapter 1, Section 3 of Part 4 Pa04 is composed of a calibration target area including a heading and a text (not shown).

[0074] (Chapter 1, Section 4 of Part 4 Pa04) Chapter 1, Section 4 of Part 4 Pa04 is composed of a calibration target area including a third heading a3 and a third text b3 (see Figure 9). The third heading a3 of Chapter 1, Section 4 of Part 4 Pa04 includes the character string "International Joint Trial: Phase 3 Randomized Double - Blind Comparative Trial". The third main text b3 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 includes at least one of character information and graphic information regarding the character string "International Joint Test: Phase 3 Randomized Double-Blind Comparative Test". The third main text b3 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 has the first sub-section Su01 to the fifth sub-section Su05.

[0075] (The first sub-section Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04) The first sub-section Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 is composed of a calibration target area including the fourth heading a4 and the fourth main text b4. The fourth heading a4 of the first sub-section Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 includes the character string "Test Summary". The fourth main text b4 of the first sub-section Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 includes at least one of character information and graphic information regarding the character string "Test Summary". The fourth main text b4 of the first sub-section Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 has the first paragraph Pr01 to the sixth paragraph Pr06.

[0076] (The first paragraph Pr01 of the first sub-section Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04) The first paragraph Pr01 of the first sub-section Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 is composed of a calibration target area including the fifth heading a5 and the fifth main text a5. The fifth heading a5 of the first paragraph Pr01 of the first sub-section Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 includes the character string "Objective". The fifth text b5 of the first paragraph Pr01 of the first subsection Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information regarding the character string "purpose".

[0077] (The second paragraph Pr02 of the first subsection Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04) The second paragraph Pr02 of the first subsection Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 is composed of a calibration target area including a fifth heading a5 and a fifth text a5. The fifth heading a5 of the second paragraph Pr02 of the first subsection Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 contains the character string "target". The fifth text b5 of the second paragraph Pr02 of the first subsection Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information regarding the character string "target".

[0078] (The third paragraph Pr03 of the first subsection Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04) The third paragraph Pr03 of the first subsection Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 is composed of a calibration target area including a fifth heading a5 and a fifth text a5. The fifth heading a5 of the third paragraph Pr03 of the first subsection Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 contains the character string "design". The fifth text b5 of the third paragraph Pr03 of the first subsection Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information regarding the character string "design".

[0079] (Section 4, Subsection 1, Paragraph 4, Chapter 1, Part 4, Pa04) The 4th paragraph (Pr04) of the 1st subsection (Su01) of the 4th section (Se04) of the 1st chapter (Ch01) of the 4th part (Pa04) consists of a calibration target area including a 5th heading (a5) and a 5th body text (a5). The 5th heading (a5) of the 4th paragraph (Pr04) of the 1st subsection (Su01) of the 4th section (Se04) of the 1st chapter (Ch01) of the 4th part (Pa04) contains the character string "Method". The 5th body text (b5) of the 4th paragraph (Pr04) of the 1st subsection (Su01) of the 4th section (Se04) of the 1st chapter (Ch01) of the 4th part (Pa04) contains at least one of character information and graphic information related to the character string "Method".

[0080] (Section 4, Subsection 1, Paragraph 5, Chapter 1, Part 4, Pa04) The 5th paragraph (Pr05) of the 1st subsection (Su01) of the 4th section (Se04) of the 1st chapter (Ch01) of the 4th part (Pa04) consists of a calibration target area including a 5th heading (a5) and a 5th body text (a5). The 5th heading (a5) of the 5th paragraph (Pr05) of the 1st subsection (Su01) of the 4th section (Se04) of the 1st chapter (Ch01) of the 4th part (Pa04) contains the character string "Evaluation Items". The 5th body text (b5) of the 5th paragraph (Pr05) of the 1st subsection (Su01) of the 4th section (Se04) of the 1st chapter (Ch01) of the 4th part (Pa04) contains at least one of character information and graphic information related to the character string "Evaluation Items".

[0081] (Section 4, Subsection 1, Paragraph 6, Chapter 1, Part 4, Pa04) The 6th paragraph (Pr06) of the 1st subsection (Su01) of the 4th section (Se04) of the 1st chapter (Ch01) of the 4th part (Pa04) consists of a calibration target area including a 5th heading (a5) and a 5th body text (a5). The fifth heading a5 of the first paragraph Pr06 of the first subsection Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 contains the character string "Analysis Plan". The fifth body text b5 of the first paragraph Pr06 of the first subsection Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information regarding the character string "Analysis Plan".

[0082] (The second subsection Su02 - third subsection Su03 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04) Each of the second subsection Su02 - third subsection Su03 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 is composed of a proofreading target area including a heading and a body text (not shown).

[0083] (The fourth subsection Su04 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04) The fourth subsection Su04 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 is composed of a proofreading target area including a fourth heading a4 and a fourth body text b4. The fourth heading a4 of the fourth subsection Su04 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 contains the character string "Japanese Sub - group (Sub - group Analysis)". The fourth body text b4 of the fourth subsection Su04 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 contains at least one of character information and graphic information regarding the character string "Japanese Sub - group (Sub - group Analysis)".

[0084] (The fifth subsection Su05 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04) The fifth subsection Su05 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 is composed of a proofreading target area including a heading and a body text (not shown).

[0085] (Chapter 01, Section 05 - Section 06 of Part Pa04) Each of Section 05 - Section 06 of Chapter 01 of Part Pa04 is composed of a proofreading target area including a heading and a text (not shown).

[0086] (Chapter 02 of Part Pa04) Chapter 02 of Part Pa04 is composed of a proofreading target area including a second - level heading a2 and a second - level text b2 (see Figure 10). The second - level heading a2 of Chapter 02 of Part Pa04 contains the character string "Disease YYY". The second - level text b2 of Chapter 02 of Part Pa04 contains at least one of character information and graphic information related to the character string "Disease YYY". The second - level text b2 of Chapter 02 of Part Pa04 has Section 01 - Section 02.

[0087] (Section 01 of Chapter 02 of Part Pa04) Section 01 of Chapter 02 of Part Pa04 is composed of a proofreading target area including a third - level heading a3 and a third - level text b3. The third - level heading a3 of Section 01 of Chapter 02 of Part Pa04 contains the character string "International Joint Trial: Phase 3 Randomized Double - Blind Comparative Trial". The third - level text b3 of Section 01 of Chapter 02 of Part Pa04 contains at least one of character information and graphic information related to the character string "International Joint Trial: Phase 3 Randomized Double - Blind Comparative Trial". The third - level text b3 of Section 01 of Chapter 02 of Part Pa04 has Sub - section 01 - Sub - section 04.

[0088] (Chapter 1, Section 1, Subsection 1 of Chapter 2, Part 4 (Pa04)) Chapter 1, Section 1, Subsection 1 of Chapter 2, Part 4 (Pa04) consists of an area to be corrected that includes a fourth heading (a4) and a fourth body text (b4). The fourth heading (a4) of Chapter 1, Section 1, Subsection 1 of Chapter 2, Part 4 (Pa04) contains the character string "Test Summary". The fourth body text (b4) of Chapter 1, Section 1, Subsection 1 of Chapter 2, Part 4 (Pa04) includes at least one of character information and graphic information related to the character string "Test Summary". The fourth body text (b4) of Chapter 1, Section 1, Subsection 1 of Chapter 2, Part 4 (Pa04) has a first paragraph (Pr01) to a sixth paragraph (Pr06).

[0089] (First paragraph (Pr01) of Chapter 1, Section 1, Subsection 1 of Chapter 2, Part 4 (Pa04)) The first paragraph (Pr01) of Chapter 1, Section 1, Subsection 1 of Chapter 2, Part 4 (Pa04) consists of an area to be corrected that includes a fifth heading (a5) and a fifth body text (b5). The fifth heading (a5) of the first paragraph (Pr01) of Chapter 1, Section 1, Subsection 1 of Chapter 2, Part 4 (Pa04) contains the character string "Purpose". The fifth body text (b5) of the first paragraph (Pr01) of Chapter 1, Section 1, Subsection 1 of Chapter 2, Part 4 (Pa04) includes at least one of character information and graphic information related to the character string "Purpose".

[0090] (Second paragraph (Pr02) of Chapter 1, Section 1, Subsection 1 of Chapter 2, Part 4 (Pa04)) The second paragraph Pr02 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 consists of a calibration target area including the fifth heading a5 and the fifth text a5. The fifth heading a5 of the second paragraph Pr02 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 contains the character string "target". The fifth text b5 of the second paragraph Pr02 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 contains at least one of character information and graphic information regarding the character string "target".

[0091] (The third paragraph Pr03 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04) The third paragraph Pr03 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 consists of a calibration target area including the fifth heading a5 and the fifth text a5. The fifth heading a5 of the third paragraph Pr03 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 contains the character string "design". The fifth text b5 of the third paragraph Pr03 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 contains at least one of character information and graphic information regarding the character string "design".

[0092] (The fourth paragraph Pr04 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04) The fourth paragraph Pr04 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 consists of a calibration target area including the fifth heading a5 and the fifth text a5. The fifth heading a5 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 contains the string "Method". The fifth body text b5 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 contains at least one of character information and graphic information regarding the string "Method".

[0093] (The fifth paragraph Pr05 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04) The fifth paragraph Pr05 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 is composed of a calibration target area including the fifth heading a5 and the fifth body text a5. The fifth heading a5 of the fifth paragraph Pr05 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 contains the string "Evaluation Items". The fifth body text b5 of the fifth paragraph Pr05 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 contains at least one of character information and graphic information regarding the string "Evaluation Items".

[0094] (The sixth paragraph Pr06 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04) The sixth paragraph Pr06 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 is composed of a calibration target area including the fifth heading a5 and the fifth body text a5. The fifth heading a5 of the sixth paragraph Pr06 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 contains the string "Analysis Plan". The fifth sentence b5 of the sixth paragraph Pr06 of the first subsection Su01 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 contains at least one of character information and graphic information regarding the character string "analysis plan".

[0095] (The second subsection Su02 to the fourth subsection Su04 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04) Each of the second subsection Su02 to the fourth subsection Su04 of the first section Se01 of the second chapter Ch02 of the fourth part Pa04 is composed of a calibration target area including a heading and a text (not shown).

[0096] (The second section Se02 of the second chapter Ch02 of the fourth part Pa04) The second section Se02 of the second chapter Ch02 of the fourth part Pa04 is composed of a calibration target area including a heading and a text (not shown).

[0097] (The third chapter Ch03 to the seventh chapter Ch07 of the fourth part Pa04) The third chapter Ch03 to the seventh chapter Ch07 of the fourth part Pa04 are composed of calibration target areas including headings and texts (not shown).

[0098] (The fifth part Pa05) The fifth part Pa05 is composed of a calibration target area including a first heading a1 and a first text b1 (see Figure 11). The first heading a1 of the fifth part Pa05 contains the character string "pharmacokinetics". The first text b1 of the fifth part Pa05 contains at least one of character information and graphic information regarding the character string "pharmacokinetics". The first text b1 of the fifth part Pa05 has the first chapter Ch01 to the sixth chapter Ch06.

[0099] (The first chapter Ch01 of the fifth part Pa05) Chapter Ch01 of Part Pa05 is composed of a correction target area including a second heading a2 and a second text b2. The second heading a2 of Chapter Ch01 of Part Pa05 includes the character string "Blood concentration". The second text b2 of Chapter Ch01 of Part Pa05 includes at least one of character information and graphic information related to the character string "Blood concentration".

[0100] (Chapter Ch02 of Part Pa05) Chapter Ch02 of Part Pa05 is composed of a correction target area including a second heading a2 and a second text b2. The second heading a2 of Chapter Ch02 of Part Pa05 includes the character string "Absorption". The second text b2 of Chapter Ch02 of Part Pa05 includes at least one of character information and graphic information related to the character string "Absorption". The second text b2 of Chapter Ch02 of Part Pa05 has Sections Se01 to Se03.

[0101] (Section Se01 of Chapter Ch02 of Part Pa05) Section Se01 of Chapter Ch02 of Part Pa05 is composed of a correction target area including a third heading a3 and a third text b3. The third heading a3 of Section Se01 of Chapter Ch02 of Part Pa05 includes the character string "Effect of diet (foreign data)". The third text b3 of Section Se01 of Chapter Ch02 of Part Pa05 includes at least one of character information and graphic information related to the character string "Effect of diet (foreign data)".

[0102] (Section Se02 of Chapter Ch02 of Part Pa05) Section Se02 of Chapter Ch02 of Part Pa05 is composed of a correction target area including a third heading a3 and a third text b3. The third heading a3 of the second section Se02 of the second chapter Ch02 of the fifth part Pa05 contains the character string "Renal dysfunction patients (foreign data)". The third text b3 of the second section Se02 of the second chapter Ch02 of the fifth part Pa05 contains at least one of character information and graphic information regarding the character string "Renal dysfunction patients (foreign data)".

[0103] (The third section Se03 of the second chapter Ch02 of the fifth part Pa05) The third section Se03 of the second chapter Ch02 of the fifth part Pa05 is composed of an area to be proofread that includes the third heading a3 and the third text b3. The third heading a3 of the third section Se03 of the second chapter Ch02 of the fifth part Pa05 contains the character string "Renal dysfunction patients (foreign data) 102". The third text b3 of the third section Se03 of the second chapter Ch02 of the fifth part Pa05 contains at least one of character information and graphic information regarding the character string "Renal dysfunction patients (foreign data)".

[0104] (The third chapter Ch03 to the sixth chapter Ch06 of the fifth part Pa05) The third chapter Ch03 to the sixth chapter Ch06 of the fifth part Pa05 are composed of an area to be proofread that includes headings and texts (not shown).

[0105] (The sixth part Pa06) The sixth part Pa06 is composed of an area to be proofread that includes the first heading a1 and the first text b1 (see Figure 12). The first heading a1 of the sixth part Pa06 contains the character string "Drug efficacy and pharmacology". The first text b1 of the sixth part Pa06 contains at least one of character information and graphic information regarding the character string "Drug efficacy and pharmacology".

[0106] (The seventh part Pa07) The seventh part Pa07 is composed of an area to be proofread that includes the first heading a1 and the first text b1. The first heading a1 of Part 7 Pa07 includes the string "Safety Pharmacology Tests and Toxicity Tests". The first text body b1 of Part 7 Pa07 includes at least one of character information and graphic information regarding the string "Safety Pharmacology Tests and Toxicity Tests".

[0107] (Part 8 Pa08) Part 8 Pa08 is composed of a correction target area including a first heading a1 and a first text body b1. The first heading a1 of Part 8 Pa08 includes the string "Physicochemical Knowledge about the Active Ingredient". The first text body b1 of Part 8 Pa08 includes at least one of character information and graphic information regarding the string "Physicochemical Knowledge about the Active Ingredient".

[0108] (Part 9 Pa09) Part 9 Pa09 is composed of a correction target area including a first heading a1 and a first text body b1. The first heading a1 of Part 9 Pa09 includes the string "Pharmaceutical Matters". The first text body b1 of Part 9 Pa09 includes at least one of character information and graphic information regarding the string "Pharmaceutical Matters".

[0109] (Part 10 Pa10) Part 10 Pa10 is composed of a correction target area including a first heading a1 and a first text body b1. The first heading a1 of Part 10 Pa10 includes the string "Precautions for Handling". The first text body b1 of Part 10 Pa10 includes at least one of character information and graphic information regarding the string "Precautions for Handling".

[0110] (Part 11 Pa11) Part 11 Pa11 is composed of a correction target area including a first heading a1 and a first text body b1 (see Figure 13). The first heading a1 of Part 11 Pa11 includes the string "Packaging". The first main text b1 of the 11th part Pa11 includes at least one of character information and graphic information regarding the character string "packaging".

[0111] (12th part Pa12) The 12th part Pa12 is composed of a calibration target area including a first heading a1 and a first main text b1. The first heading a1 of the 12th part Pa12 includes the character string "related information". The first main text b1 of the 12th part Pa12 includes at least one of character information and graphic information regarding the character string "related information".

[0112] (13th part Pa13) The 13th part Pa13 is composed of a calibration target area including a first heading a1 and a first main text b1. The first heading a1 of the 13th part Pa13 includes the character string "main document". The first main text b1 of the 13th part Pa13 includes at least one of character information and graphic information regarding the character string "main document".

[0113] (14th part Pa14) The 14th part Pa14 is composed of a calibration target area including a first heading a1 and a first main text b1. The first heading a1 of the 14th part Pa14 includes the character string "name and address of the manufacturer or seller". The first main text b1 of the 14th part Pa14 includes at least one of character information and graphic information regarding the character string "name and address of the manufacturer or seller".

[0114] The database D1 includes a first data area D1a, a second data area D1b, and a third data area D1c. The first data area D1a, the second data area D1b, and the third data area D1c may be composed of one file or separate files.

[0115] (First data area D1a) The first data area D1a includes a string (first string) that is prohibited from being used and a list of comments when the first string is detected in all or part (first area) of the area to be corrected in the document data 100 (see FIG. 14). That is, one of the description conditions recorded in the database D1 is that the first string is not used in all or part (first area) of a plurality of areas to be corrected.

[0116] When the first data area D1a in FIG. 14 detects the string "○○", the string "It is a product name of another company and "○○" cannot be described. Please correct it to the generic name (compound name)." is displayed in the third display area P1c. When the string "××" is detected, the string "It is a product name of another company and "××" cannot be described. Please correct it to the generic name (compound name)." is displayed in the third display area P1c. When the string "△△" is detected, an example is shown where the string "It is a product name of another company and "△△" cannot be described. Please correct it to the generic name (compound name)." is displayed in the third display area P1c.

[0117] (Second data area D1b) The second data area D1b includes a first condition, a second condition, and a list of comments when the first condition is satisfied but the second condition is not satisfied (see FIG. 15).

[0118] It includes a string (second string) that must be used in a predetermined area (second area) in the area to be corrected in the document data 100, a string (third string) that must be used in the predetermined area (second area), and a list of comments when the second string is detected in the second area but the third string is not detected in the second area. That is, one of the description conditions recorded in the database D1 is that when the second string is used in the second area of a plurality of areas to be corrected, the third string is used in the second area.

[0119] In addition, it includes a list of comments when a string (second string) that must be used in a predetermined area (second area) in the area to be corrected of the document data 100, and a string (second string or third string) that must be used in an area (third area) different from the predetermined area (second area), and the second string is detected in the second area, but the second string or the third string is not detected in the third area. That is, one of the description conditions recorded in the database D1 is that when the second string is used in the second area of a plurality of areas to be corrected, the second string or the third string is used in a third area different from the second area.

[0120] The second data area D1b in FIG. 15 shows seven examples (first example to seventh example) in which the following comments are to be displayed in the third display area P1c when the following first condition is satisfied and the second condition is not satisfied.

[0121] (First example) First condition: The string "Clinical results" is included in the first heading a1 in any part. Second condition: In the third heading a3 in the part where the string "Clinical results" is included in the first heading a1, all or part of the strings "First ● Phase Trial ("●" is an arbitrary character)", "Second ● Phase Trial ("●" is an arbitrary character)", "Third ● Phase Trial ("●" is an arbitrary character)" are included. Comment to be displayed in the third display area P1c: In clinical results, any of the descriptions "First ● Phase Trial ("●" is an arbitrary character)", "Second ● Phase Trial ("●" is an arbitrary character)", "Third ● Phase Trial ("●" is an arbitrary character)" is required.

[0122] (Second example) First condition: The string "Clinical results" is included in the first heading a1 in any part. The string "Test summary" is included in the fourth heading a4 in the part where the string "Clinical results" is included in the first heading a1. Second condition: In the fifth heading a5 in the subsection containing the character string "Test Summary", all of the character strings "Purpose", "Subject", "Method", "Evaluation Items", and "Analysis Plan" are included. Comment to be displayed in the third display area P1c: In the "Test Summary" of "Clinical Results", all descriptions of "Purpose", "Subject", "Method", "Evaluation Items", and "Analysis Plan" are required.

[0123] (Third example) First condition: In the first heading a1 in any part, the character string "Clinical Results" is included. In the fourth heading a4 in the part that includes the character string "Clinical Results" in the first heading a1, the character string "Test Summary" is included. In the fifth heading a5 in the subsection that includes the character string "Test Summary" in the fourth heading a4, the character string "Evaluation Items" is included. Second condition: In the fifth body text b5 in the paragraph that includes the character string "Evaluation Items" in the fifth heading a5, the character string "Primary Evaluation Items" is included. Comment to be displayed in the third display area P1c: In the "Evaluation Items" of the "Test Summary" of "Clinical Results", the description of "Primary Evaluation Items" is required.

[0124] (Fourth example) First condition: In the first heading a1 in any part, the character string "Clinical Results" is included. In the fourth heading a4 in the part that includes the character string "Clinical Results" in the first heading a1, the character string "Test Summary" is included. In the fifth heading a5 in the subsection that includes the character string "Test Summary" in the fourth heading a4, the character string "Evaluation Items" is included. In the fifth body text b5 in the paragraph that includes the character string "Evaluation Items" in the fifth heading a5, the character string "Primary Evaluation Items" is included. Second condition: In the fourth body text b4 of another subsection in the section including the subsection including the paragraph that includes the character string "Primary Evaluation Items" in the fifth body text b5, the text "Verification Analysis Items or text related to verification analysis items" is included. Comment to be displayed in the third display area P1c: In the "Test Summary" including "Primary Evaluation Items", descriptions such as "Verification Analysis Items" are required.

[0125] (Example 5) First condition: The string "Clinical Results" is included in the first heading a1 in any part. The string "Subgroup Analysis" is included in the fourth heading a4 in the part where the string "Clinical Results" is included in the first heading a1. Second condition: In the paragraph where the string "Analysis Plan" is included in the fifth heading a5 in the section including the subsection where the string "Subgroup Analysis" is included in the fourth heading a4, the string "Subgroup Analysis" is included in the fifth body text b5. Comment to be displayed in the third display area P1c: In the "Analysis Plan" of the section including "Subgroup Analysis", the description of "Subgroup Analysis" is required.

[0126] (Example 6) First condition: The string "Clinical Results" is included in the first heading a1 in any part. The string "Test Outline" is included in the fourth heading a4 in the part where the string "Clinical Results" is included in the first heading a1. The string "Analysis Plan" is included in the fifth heading a5 in the subsection where the string "Test Outline" is included in the fourth heading a4. The string "Cochran-Mantel-Haensze Test" is included in the fifth body text b5 in the paragraph where the string "Analysis Plan" is included in the fifth heading a5. Second condition: In the section including the paragraph where the string "Analysis Plan" is included in the fifth heading a5 and the string "Cochran-Mantel-Haensze Test" is included in the fifth body text b5, the string "● Cochran-Mantel-Haensze Test adjusted by factor ("●" is any character)" is included in the fourth body text b4 in the subsection where the string "Effectiveness Evaluation" is included in the fourth heading a4. Comment to be displayed in the third display area P1c: For the "Cochran-Mantel-Haensze Test", the description of covariates and adjustment factors is required.

[0127] (Example 7) Condition 1: The string "Product Information" is included in the first heading a1 in any part. In the second heading a2 in the part where the string "Product Information" is included in the first heading a1, the string "Precautions for Patients with a Specific Background" is included. In the second body text b2 in the chapter where the string "Precautions for Patients with a Specific Background" is included in the second heading a2, "Patients with Liver Dysfunction" is included. Condition 2: In the part where the string "Pharmacokinetics" is included in the first heading a1, in the second body text b2 in the chapter where the string "Absorption" is included in the second heading a2, the string "Patients with Liver Dysfunction" or "Statement Regarding Liver Function Tests" is included, or the second body text b2 includes "Warning for Patients with Liver Dysfunction". Comment to be displayed in the third display area P1c: "Warning for Patients with Liver Dysfunction" is required. Note that the strings corresponding to "Statement Regarding Liver Function Tests" and "Warning for Patients with Liver Dysfunction" (for example, AST, ALT, etc.) are recorded in another data area (not shown), and it is determined whether the string is included in the second body text b2.

[0128] Note that the contents of Condition 1, Condition 2, and the comment are examples, and other contents may also be possible. For example, regarding the sixth example, "Cochran-Mantel-Haensze test" may be replaced with another test. Also, regarding the seventh example, "Liver Dysfunction" may be replaced with "Renal Dysfunction".

[0129] (Third data area D1c) The third data area D1c includes a list of strings that are likely to be used in each of the first heading a1 to the fifth heading a5 and the first body text b1 to the fifth body text b5 (see Figure 16). For example, in the area identification step described later, when the string "Development History" is detected, the user-side control unit 35 determines that the area including the string "Development History" is the first heading a1. However, the area including a predetermined string does not necessarily correspond to the heading or body text set in the third data area D1c. Therefore, it is desirable to identify the area based on the detection results of a plurality of character strings. For example, in the area identification step described later, when the character string "Product Information" is detected before the character string "Warning" and the character string "Taboo" is detected after the character string "Warning", the user-side control unit 35 determines that the area including the character string "Warning" is the second heading a2.

[0130] (Calibration Support Screen P1) The calibration support screen P1 displayed on the user-side output unit 37 includes a first display area P1a, a second display area P1b, and a third display area P1c (see FIGS. 17 to 26). The calibration support screen P1 is displayed with the first display area P1a, the second display area P1b, and the third display area P1c arranged horizontally. Note that, in order to specifically show an example of an incomplete description, the contents of FIGS. 17 to 26 include notations different from those of FIGS. 2 to 13.

[0131] The first display area P1a has a loaded image including part or all of the area to be calibrated in the document data 100. The loaded image is obtained by loading a file of the document data 100 configured in a file format such as PDF (Portable Document Format) or JPEG (Joint Photographic Experts Group), or by scanning the printed matter in the area to be calibrated in the document data 100 with a scanner or the like.

[0132] The second display area P1b is a character string composed of characters recognized from the loaded image of the document data 100 and corresponding to the area displayed in the first display area P1a.

[0133] The third display area P1c is a character string composed of characters recognized from the loaded image of the document data 100, and has information regarding deficiencies in the description (information regarding whether it conforms to the description conditions based on the database D1) specified corresponding to the area displayed in the second display area P1b. When scrolling any of the display screens of the first display area P1a to the third display area P1c, switching is made to the display of other pages including other display areas.

[0134] If no deficiency in the description is specified for the part displayed in the first display area P1a of the loaded image or for the part displayed in the second display area P1b of the character string, nothing is displayed in the third display area P1c, or a notation indicating that there is no deficiency in the description is made.

[0135] (Operation procedure) Next, the operation procedure will be described. In advance, the database D1 is recorded in the server recording unit 13 of the information server 10, and the database D1 of the same content is also recorded in the user-side recording unit 33 of the user terminal 30.

[0136] When the database D1 recorded in the server recording unit 13 is updated, the content of the updated database D1 is transmitted from the server communication unit 11 of the information server 10 to the user-side communication unit 31 of the user terminal 30. When the user-side communication unit 31 receives the content of the latest database D1 from the information server 10, the database D1 of the user-side recording unit 33 is updated.

[0137] The user-side control unit 35 of the user terminal 30 loads the file of the document data 100 to obtain a loaded image (image acquisition step). Alternatively, the user-side control unit 35 of the user terminal 30 scans the printed matter in the calibration target area in the document data 100 via a scanner (not shown) to obtain a loaded image (image acquisition step).

[0138] The user-side control unit 35 recognizes characters from the read image and digitizes them as text (optical character recognition) (character recognition step).

[0139] Also, the user-side control unit 35 specifies regions corresponding to headings (first headings a1 to fifth headings a5) and main texts (first main texts b1 to fifth main texts b5) in the calibration target region from the character string composed of the recognized characters (region specification step). The region specification step is performed based on the recognized characters and the third data region D1c of the database D1. However, the specification may be performed only from the recognized characters without using the third data region D1c. By the region specification step, parts, chapters, sections, subsections, and paragraphs are classified for a plurality of calibration target regions in the document data 100.

[0140] The user-side control unit 35 specifies deficiencies in the description in the calibration target region of the document data 100 (deficiency specification step). The deficiency specification step is performed based on the characters recognized in the character recognition step, the regions (headings and main texts) specified in the region specification step, and the first data region D1a and the second data region D1b of the database D1.

[0141] The user-side control unit 35 causes the user-side output unit 37 to display the first display region P1a, the second display region P1b, and the third display region P1c side by side (output step).

[0142] In the deficiency specification step, when a deficiency is specified assuming that all of the plurality of calibration target regions or the first string is used in the first region, the first display region P1a has a region including the first string in the read image, the second display region P1b has a character string including the first string in the document data 100, and the third display region P1c has information regarding the deficiency including the first string.

[0143] For example, if the character string "··· compared with the monotherapy of ○○ ···" specified as the fifth main text b5 in the first paragraph Pr01 of the first sub-section Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 contains the character string "○○", the user-side control unit 35 determines that the fifth main text b5 is incomplete.

[0144] In this embodiment, it is determined whether the first character string is used in all of the plurality of calibration target areas. However, it may be determined whether the first character string is used in a part of the plurality of calibration target areas (corresponding to the first area). The character string "○○" corresponds to the first character string.

[0145] In this case, the user-side output unit 37 causes the string "Since it is the product name of another company, "○○" cannot be described. Please correct it to the generic name (compound name)." to be displayed in the third display area P1c as a comment regarding the incompleteness of the fifth main text b5. In the first display area P1a and the second display area P1b, areas corresponding to the fifth main text b5 are displayed (see FIG. 17). FIG. 17 shows an example in which it is determined that there is an incompleteness in the fifth main text b5 in the first paragraph Pr01 of the first sub-section Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 because the character string "○○" whose use is prohibited is described.

[0146] Similarly, if the character string "··· during the administration of a certain dose of ○○ ···" specified as the fourth main text b4 in the first sub-section Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 contains the character string "○○", the user-side control unit 35 determines that the fourth main text b4 is incomplete.

[0147] In this case, the user-side output unit 37 displays, in the third display area P1c, as a comment regarding the incompleteness of the description of the fourth text b4, the character string "Since it is a product name of another company, '○○' cannot be described. Please correct it to the generic name (compound name).". In the first display area P1a and the second display area P1b, areas corresponding to the fourth text b4 are displayed (see Fig. 18). Fig. 18 shows an example in which, in the fourth text b4 in the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04, since the character string "○○" which is prohibited from being used is described, it is determined that there is an incompleteness in the description.

[0148] Also, in the step of specifying the incompleteness of the description, when it is specified that there is an incompleteness in the second area assuming that the second character string is used in the second area and the third character string is not used in the second area, the first display area P1a has the second area in the loaded image, the second display area P1b has the character string including the second area in the document data 100, and the third display area P1c has information regarding the incompleteness of the description including the third character string.

[0149] For example, if the character string "Clinical results" is included in the character string specified as the first heading a1 in the fourth part Pa04, but at least one of the character strings "First ● trial", "Second ● phase trial", and "Third ● phase trial" is not included in the character string "International joint trial: randomized double-blind comparative trial" specified as the third heading a3 in the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04, the user-side control unit 35 determines that the third heading a3 has an incompleteness in the description.

[0150] The fourth part Pa04 corresponds to the second area. The character string "Clinical results" corresponds to the second character string. At least one of the character strings "First ● trial", "Second ● phase trial", and "Third ● phase trial" corresponds to the third character string.

[0151] In this case, the user-side output unit 37 displays, in the third display area P1c, as a comment regarding the lack of description of the third heading a3, the character string "Any one of the descriptions 'First ● Test', 'Second ● Phase Test', and 'Third ● Phase Test' is required." In the first display area P1a and the second display area P1b, areas corresponding to the third heading a3 are displayed (see Fig. 17). Fig. 17 shows an example determined to be incomplete in description because, in the third heading a3 in the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04, where the character string "Third Phase Randomized Double-Blind Comparative Test" should be described, the character string "Randomized Double-Blind Comparative Test" is described instead.

[0152] Also, for example, if the character string specified as the first heading a1 in the fourth part Pa04 includes the character string "Clinical Results", and the character string specified as the fourth heading a4 in the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 includes the character string "Test Outline", but the character string "Purpose... " specified as the fourth main text b4 in the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 does not include at least one of the character strings "Purpose", "Subject", "Method", "Evaluation Item", and "Analysis Plan" (here, "Subject"), the user-side control unit 35 determines that the fourth main text b4 is incomplete in description.

[0153] The fourth part Pa04 corresponds to the second area. The character strings "Clinical Results" and "Test Outline" correspond to the second character string. The character strings "Purpose", "Subject", "Method", "Evaluation Item", and "Analysis Plan" correspond to the third character string.

[0154] In this case, the user-side output unit 37 displays, in the third display area P1c, as a comment regarding the incompleteness of the description of the fourth main text b4, the character string "In the 'Test Outline' of 'Clinical Results', all descriptions of 'Purpose', 'Subjects', 'Methods', 'Evaluation Items', and 'Analysis Plan' are required." (see Fig. 18). In the first display area P1a and the second display area P1b, areas corresponding to the fourth main text b4 are displayed. Fig. 18 shows an example where, in the fourth main text b4 in the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04, the character string "Subjects" is not described, and thus it is determined to be incomplete.

[0155] Also, for example, if the character string specified as the first heading a1 in the fourth part Pa04 includes the character string "Clinical Results", the character string specified as the fourth heading a4 in the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 includes the character string "Test Outline", and the character string specified as the fifth heading a5 in the fifth paragraph Pr05 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 includes the character string "Evaluation Items", but the character string "Primary Evaluation Items" is not included in the character string "<Effectiveness> Improvement rate of ZZZ at ★ weeks..." specified as the fifth main text b5 in the fifth paragraph Pr05 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04, the user-side control unit 35 determines that the fifth main text b5 is incomplete.

[0156] The fourth part Pa04 corresponds to the second area. The character strings "Clinical Results", "Test Outline", and "Evaluation Items" correspond to the second character string. The character string "Primary Evaluation Items" corresponds to the third character string.

[0157] In this case, the user-side output unit 37 displays, in the third display area P1c, as a comment regarding the incompleteness of the description of the fifth text b5, the character string "In the 'Evaluation Items' of the 'Test Outline' of 'Clinical Results', it is necessary to describe the 'Primary Evaluation Items'." (see Fig. 19). In the first display area P1a and the second display area P1b, areas corresponding to the fifth text b5 are displayed. Fig. 19 shows an example in which, in the fifth text b5 in the fifth paragraph Pr05 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04, since the character string "Primary Evaluation Items" is not described, it is determined that there is an incompleteness in the description.

[0158] Also, for example, if the character string specified as the first heading a1 in the fourth part Pa04 includes the character string "Clinical Results", the character string specified as the fourth heading a4 in the first subsection Su01 of the second section Se02 of the first chapter Ch01 of the fourth part Pa04 includes the character string "Test Outline", the character string specified as the fifth heading a5 in the fifth paragraph Pr05 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 includes the character string "Evaluation Items", and the character string specified as the fifth text b5 in the fifth paragraph Pr05 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 includes the character string "Primary Evaluation Items", but the character string "Effectiveness Evaluation 1.ZZZ Improvement Rate ···" specified as the fourth text b4 in the third subsection Su03 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 does not include a statement "related to a verification analysis item or a statement related to a verification analysis item", the user-side control unit 35 determines that the fourth text b4 has an incomplete description.

[0159] The fourth part Pa04 corresponds to the second area. The character strings "Clinical Results", "Test Outline", "Evaluation Items", and "Primary Evaluation Items" correspond to the second character string. The "text related to the verification analysis item or the verification analysis item" corresponds to the third string.

[0160] In this case, the user-side output unit 37 displays, in the third display area P1c, as a comment regarding the deficiency in the description of the fourth text b4, the character string "In the 'Test Outline' including the 'Main Evaluation Item', descriptions such as 'Verification Analysis Item' are required." (see Fig. 20). In the first display area P1a and the second display area P1b, areas corresponding to the fourth text b4 are displayed. Fig. 20 shows an example where, in the fourth text b4 in the third sub-section Su03 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04, where the character string "Verification Analysis Item" should be described, the character string "Analysis Item" is described, and thus it is determined to be a deficiency in the description.

[0161] In the deficiency identification step, when it is determined that the second string is used in the second area and the second string or the third string is not used in the third area and a deficiency is identified, the first display area P1a has the third area in the loaded image, the second display area P1b has the character string including the third area in the document data 100, and the third display area P1c has information regarding the deficiency including the second string or the third string.

[0162] For example, if the character string specified as the first heading a1 in the fourth part Pa04 includes the character string "Clinical Results", and the character string specified as the fourth heading a4 in the fourth sub-section Su04 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 includes the character string "Subgroup Analysis", but the character string "Subgroup Analysis" is not included in the character string "Regarding the main evaluation item,..." specified as the fifth text b5 in the sixth paragraph Pr06 of the first sub-section Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04, the user-side control unit 35 determines that the fifth text b5 is a deficiency in the description.

[0163] The fourth sub-subsection Su04 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 corresponds to the second region. The sixth paragraph Pr06 of the first sub-section Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04 corresponds to the third region. The character strings "clinical results" and "subgroup analysis" correspond to the second character string. The character string "subgroup analysis" corresponds to the third character string. That is, part or all of the second character string and the third character string may match.

[0164] In this case, the user-side output unit 37 causes the character string "In the 'analysis plan' of the section containing'subgroup analysis', it is necessary to describe'subgroup analysis'." to be displayed in the third display area P1c as a comment regarding the insufficiency of the description of the fifth text b5 (see FIG. 21). In the first display area P1a and the second display area P1b, areas corresponding to the fifth text b5 are displayed. FIG. 21 shows an example in which it is determined that there is an insufficiency in the description because the character string "subgroup analysis" is not described in the fifth text b5 in the sixth paragraph Pr06 of the first sub-section Su01 of the fourth section Se04 of the first chapter Ch01 of the fourth part Pa04.

[0165] Also, for example, the string identified as the first heading a1 in the fourth part Pa04 contains the string "Clinical Results", the string identified as the fourth heading a4 in the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains the string "Test Summary", the string identified as the fifth heading a5 in the sixth paragraph Pr06 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains the string "Analysis Plan", the string identified as the fifth main text b5 in the sixth paragraph Pr06 of the first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 contains the string "Cochran-Mantel-Haensze Test". However, if the string "···Cochran-Mantel-Haenszel Test···" identified as the fourth main text b4 in the third subsection Su03 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 does not contain the string "● Cochran-Mantel-Haensze Test Adjusted by Factor ("●" is an arbitrary character)", the user-side control unit 35 determines that the fourth main text b4 is incomplete.

[0166] The first subsection Su01 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 corresponds to the second area. The third subsection Su03 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04 corresponds to the third area. The strings "Clinical Results", "Test Summary", "Analysis Plan", and "Cochran-Mantel-Haensze Test" correspond to the second string. The string "● Cochran-Mantel-Haensze Test Adjusted by Factor ("●" is an arbitrary character)" corresponds to the third string.

[0167] In this case, the user-side output unit 37 displays, in the third display area P1c, as a comment regarding the incompleteness of the description of the fourth text b4, the character string "For the 'Cochran-Mantel-Haenszel test', descriptions of covariates and adjustment factors are required." (see Fig. 22). In the first display area P1a and the second display area P1b, areas corresponding to the fourth text b4 are displayed. Fig. 22 shows an example determined to be incomplete because the character string "● Cochran-Mantel-Haensze test adjusted by a factor ("●" is an arbitrary character)" is not described in the fourth text b4 in the third sub-section Su03 of the first section Se01 of the first chapter Ch01 of the fourth part Pa04.

[0168] Also, for example, the character string specified as the first heading a1 in the third part Pa03 includes the character string "Product information", the character string specified as the second heading a2 in the ninth chapter Ch09 of the third part Pa03 includes the character string "Precautions regarding patients with a specific background", and the character string specified as the second text b2 in the ninth chapter Ch09 of the third part Pa03 includes the character string "Patients with liver dysfunction". However, the character string "Effect of diet (foreign data) ··· ★ dysfunction patients ··· ◎ dysfunction patients ··· ("★" and "◎" are misrecognized characters)" specified as the second text b2 in the second chapter Ch02 of the fifth part Pa05 does not include the character string "Patients with liver dysfunction" or the text related to liver function tests, or the second text b2 does not include "Warning to patients with liver dysfunction". In this case, the user-side control unit 35 determines that the second text b2 is incomplete.

[0169] The third part Pa03 corresponds to the second area. The fifth part Pa05 corresponds to the third area. The character strings "Product information", "Precautions regarding patients with a specific background", and "Patients with liver dysfunction" correspond to the second character string. The character string "patients with liver function impairment" or "language related to liver function tests", or in the second main text b2, the "Warning to patients with liver function impairment" corresponds to the third character string.

[0170] In this case, the user-side output unit 37 displays the character string "A warning to 'patients with liver function impairment' is required." in the third display area P1c as a comment regarding the incompleteness of the description of the second main text b2 (see Fig. 23). In the first display area P1a and the second display area P1b, areas corresponding to the second main text b2 are displayed. Fig. 23 shows an example in which the second main text b2 in the second chapter Ch02 of the fifth part Pa05 actually contains the character string "patients with liver function impairment", but due to a reading error, it was erroneously recognized as "◎ patients with function impairment" in character recognition and was determined to be incomplete.

[0171] (Application example of the second display area P1b) In the second display area P1b, it is desirable that among the character strings composed of the characters recognized in the character recognition step, the part related to the incompleteness of the description is displayed in an emphasized state compared to other areas. In particular, when there are multiple comments (information regarding incompleteness of the description) displayed in the third display area P1c, in the second display area P1b, it is desirable that among the character strings composed of the characters recognized in the character recognition step, the first part related to the incompleteness of the description is displayed in an emphasized state in a different way from the second part related to other incompleteness of the description. In this case, in the third display area P1c, it is desirable that among the information regarding the incompleteness of the description, the area corresponding to the first part is displayed in an emphasized state in the same way as the first part, and among the information regarding the incompleteness of the description, the area corresponding to the second part is displayed in an emphasized state in the same way as the second part. FIG. 24 shows an example in which the first part "International Joint Test: Randomized Double-Blind Comparative Test:" and the second part "○○" are displayed in different frame lines and emphasized compared to other areas. In the third display area P1c, the area corresponding to the first part, "In clinical results, descriptions of any of 'First ● Test', 'Second ● Phase Test', and 'Third ● Phase Test' are required.", is displayed in the same frame line as the first part and emphasized. The area corresponding to the second part, "Since it is the product name of another company, '○○' cannot be described. Please correct it to the generic name (compound name).", is displayed in the same frame line as the second part and emphasized.

[0172] (Application Example of Display Area Arrangement) In this embodiment, an example where the first display area P1a, the second display area P1b, and the third display area P1c are arranged horizontally has been described. However, the arrangement of the first display area P1a, the second display area P1b, and the third display area P1c is not limited to the horizontal direction. For example, the arrangement may be in the vertical direction (see FIG. 25). Also, the arrangement may be such that the first display area P1a and the third display area P1c are arranged vertically, and the second display area P1b is arranged horizontally in the area including the first display area P1a and the third display area P1c (see FIG. 26).

[0173] (Application Example of Document Data 100) In this embodiment, the document data 100 has been described as an overview of comprehensive product information of pharmaceuticals. However, the document data 100 to be calibrated by the calibration support system 1 in this embodiment is not limited to the overview of comprehensive product information of pharmaceuticals. For example, the document data 100 may be a presentation document of the pharmaceutical used by a doctor. Also, the document data 100 may include a plurality of data related to pharmaceuticals. For example, the document data 100 may include both an overview of comprehensive product information of pharmaceuticals and a presentation document of the pharmaceutical used by a doctor. In this case, the calibration support program may generate, by a predetermined operation, a file including the comprehensive product information summary from the document data 100 and a file including the presentation document. Also, the document data 100 is not limited to pharmaceutical materials, and may be materials in other fields such as contracts.

[0174] (It is also possible to use the database D1 in the server recording unit 13 without recording the database D1 in the user-side recording unit 33) In this embodiment, a form of identifying incompleteness in the document data 100 using the database D1 recorded in the user-side recording unit 33 has been described. However, the user terminal 30 may communicate with the information server 10 and identify incompleteness in the document data 100 using the database D1 recorded in the server recording unit 13 of the information server 10.

[0175] (Application example of the server control unit 15) In this embodiment, an example in which the calibration support program is installed in the user-side recording unit 33 and the user-side control unit 35 executes the calibration support program has been described. However, the user-side control unit 35 may perform only operations related to input, output, and communication, such as displaying the calibration support screen P1 on the browser, and the server control unit 15 may execute the calibration support program (image acquisition step, character recognition step, area identification step, incompleteness identification step, output step).

[0176] (Effect of recognizing characters from the read image of the calibration target area of the document data and identifying incompleteness by comparing with the database D1) For documents with a large number of characters and many description conditions, such as the comprehensive product information summary of pharmaceuticals, it is possible to recognize characters from the read image and identify incompleteness that does not meet the description conditions from the recognized characters, facilitating the calibration of the document data 100.

[0177] (Effect of arranging and displaying the first display area P1a, the second display area P1b, and the third display area P1c) The loaded image, the character string composed of the recognized characters, and the information regarding the incompleteness of the description can be arranged and displayed, facilitating the proofreading of the document data 100. In particular, since the character string composed of the recognized characters is displayed in the second display area P1b, it is possible to easily distinguish between an error in recognizing characters such as garbled characters and a character recognition error, and the true incompleteness of the description in the loaded image.

[0178] (Effect of detecting that the first character string is used as an incompleteness of the description) The state in which the first character string prohibited from being used under the description conditions is erroneously used can be easily visually recognized.

[0179] (Effect of detecting that the second character string or the third character string is not used as an incompleteness of the description) The state in which the second character string, etc. that are required to be used under the description conditions are not erroneously used can be easily visually recognized.

[0180] (Effect of highlighting the part related to the incompleteness of the description) Compared with the form of highlighting the location identified as an incompleteness in the first display area P1a, highlighting can be carried out easily and accurately

[0181] (Effect of highlighting the parts related to multiple incompletenesses separately) The differences between the parts related to multiple incompletenesses can be easily visually recognized.

[0182] Although several embodiments of the present invention have been described, these embodiments are presented as examples and are not intended to limit the scope of the invention. These embodiments can be implemented in various other forms, and various omissions, replacements, and changes can be made without departing from the gist of the invention. These embodiments and their modifications are included in the scope and gist of the invention, and are also included in the invention described in the claims and the equivalent scope thereof.

Explanation of Symbols

[0183] 1 Calibration Support System 10 Information Server 11 Server Communication Unit 13 Server Recording Unit 15 Server Control Unit 30 User Terminal 31 User-Side Communication Unit 33 User-Side Recording Unit 35 User-Side Control Unit 36 User-Side Input Unit 37 User-Side Output Unit a1~a5 First Heading~Fifth Heading b1~b5 First Text~Fifth Text Ch01~Ch16 First Chapter~Sixteenth Chapter D1 Database D1a First Data Area D1b Second Data Area D1c Third Data Area P1 Calibration Support Screen P1a First Display Area P1b Second Display Area P1c Third Display Area Pa01~Pa14 First Part~Fourteenth Part Pr01~Pr06 First Paragraph~Sixth Paragraph Se01~Se06 First Section~Sixth Section Su01~Su05 First Sub-Section~Fifth Sub-Section

Claims

1. A control unit, an output unit, and is configured to execute an image acquisition step of obtaining a read image including the calibration target area by loading or scanning document data having a plurality of calibration target areas, a character recognition step of recognizing characters from the read image, a description defect identification step of identifying a description defect in the calibration target area based on the characters recognized in the character recognition step and a database including predetermined description conditions, and an output step of causing the output unit to display a first display area, a second display area, and a third display area side by side, wherein the first display area has the read image, the second display area has a character string composed of the characters recognized in the character recognition step, and the third display area has information regarding the description defect, a calibration support system.

2. The description condition is that a first character string is not used in all or a first area of the plurality of calibration target areas, and in the description defect identification step, when the description defect is identified assuming that the first character string is used in all or the first area, the first display area has an area including the first character string in the read image, the second display area has a character string including the first character string in the document data, and the third display area has information regarding the description defect including the first character string, the calibration support system according to claim 1.

3. The description condition is that when a second character string is used in a second area of the plurality of calibration target areas, a third character string is used in the second area, and in the description defect identification step, when the description defect is identified assuming that the second character string is used in the second area and the third character string is not used in the second area, the first display area has the second area in the read image, the second display area has a character string including the second area in the document data, and the third display area has information regarding the description defect including the third character string, the calibration support system according to claim 1.

4. The description condition is that when a second character string is used in a second area of the plurality of calibration target areas, the second character string or the third character string is used in a third area different from the second area, In the step of identifying the deficiency in the description, when it is determined that the second character string is used in the second area and neither the second character string nor the third character string is used in the third area, the first display area has the third area in the loaded image, the second display area has a character string including the third area in the document data, and the third display area has information regarding the deficiency in the description including the second character string or the third character string. The proofreading support system according to claim 1.

5. In the second display area, among the character strings composed of the characters recognized in the character recognition step, a first part related to the deficiency in the description is displayed in an emphasized state in a different manner from a second part related to the deficiency in the description. In the third display area, among the information regarding the deficiency in the description, an area corresponding to the first part is displayed in an emphasized state in the same manner as the first part. In the third display area, an area corresponding to the second part is displayed in an emphasized state in the same manner as the second part. The proofreading support system according to claim 1.

6. In a proofreading support method executed by a control unit in a proofreading support system including the control unit and an output unit, an image acquisition step of obtaining a loaded image including the proofreading target area by loading or scanning document data having a plurality of proofreading target areas; a character recognition step of recognizing characters from the loaded image; a step of identifying deficiencies in the description in the proofreading target area based on the characters recognized in the character recognition step and a database including predetermined description conditions; an output step of causing the output unit to display a first display area, a second display area, and a third display area side by side, wherein the first display area has the loaded image, the second display area has a character string composed of the characters recognized in the character recognition step, and the third display area has information regarding the deficiency in the description. A proofreading support method.

7. In a proofreading support program executed by a control unit in a proofreading support system including the control unit and an output unit, an image acquisition step of obtaining a loaded image including the proofreading target area by loading or scanning document data having a plurality of proofreading target areas; a character recognition step of recognizing characters from the loaded image; A description defect identification step of identifying a description defect in the calibration target area based on the characters recognized in the character recognition step and a database including predetermined description conditions; An output step of causing the output unit to display the first display area, the second display area, and the third display area side by side, and executes; The first display area has the read image; The second display area has a character string composed of the characters recognized in the character recognition step; The third display area has information regarding the description defect, a calibration support program.

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