Survival confirmation investigation system, computer, survival confirmation investigation method, and program

Abstract

In order to prevent a CRC from having an excessive work burden and also to reduce the likelihood of burden on a subject, and to improve efficiency of survival investigation, this survival confirmation investigation system for confirming the survival of a subject in a clinical trial generates a clinical trial project conforming to a clinical trial protocol, sets a predetermined distribution schedule for each subject on the basis of the clinical trial project, distributes a confirmation message for the subject relating to survival confirmation of the subject and a multiple-choice question on the basis of the distribution schedule, acquires an answer to the question, and manages the answer for each subject.

Description

Survival confirmation survey system, computer, survival confirmation survey method and program

[0001] This invention relates to a technology effective for confirming the survival of subjects in clinical trials.

[0002] Traditionally, clinical trials have been conducted to obtain legal approval for the manufacture and sale of unapproved or off-label drugs or medical devices. In these trials, a Clinical Research Coordinator (CRC) acts as a liaison between pharmaceutical companies, medical device manufacturers, medical institutions, and the subjects (patients) participating in the trial. As disclosed in Non-Patent Document 1, the CRC's role, under the guidance and supervision of the principal investigator, includes obtaining informed consent, attending interviews and examinations, managing schedules, providing medication guidance and checking concomitant medications, collecting clinical trial data and managing documents, and communicating and coordinating with relevant departments.

[0003] National Research and Development Agency, National Center for Global Health and Medicine, Clinical Research Center, Clinical Trials Management Office, "What is the job of a CRC? | Clinical Research Center, Clinical Trials Management Office," [online], [Retrieved December 19, 2024], Internet <URL: https: / / ccs.ncgm.go.jp / ctmo / patient / 004.html>

[0004] The survival confirmation by CRC is conducted by phone for the subject or the subject's agent (such as family). Therefore, the subject or the agent has to directly respond by phone even though the subject is ill, which has been a burden for both CRC and the subject or the agent. As a result, CRC has issues such as the burden of making phone calls and the need to ask detailed questions and feel stressed when the subject's condition is not good. In addition, in the response by phone, since it is a direct conversation with the subject or the agent, the response time for each case tends to be long, and it has not been easy for CRC to appropriately manage the timing of making phone calls to dozens of subjects and smoothly conduct the survival confirmation. Thus, the survival confirmation has become an excessive workload for CRC and an inefficient process. Therefore, there is a need for a technology that does not impose an excessive workload on CRC, is less burdensome for the subject, and makes the survival confirmation efficient.

[0005] An object of the present invention is to provide a survival confirmation survey system, a computer, a survival confirmation survey method, and a program that do not impose an excessive workload on CRC, are less burdensome for the subject, and can efficiently conduct the survival confirmation.

[0006] The present invention provides a survival confirmation survey system for conducting the survival confirmation of subjects in a clinical trial, comprising: a project generation unit that generates a clinical trial project in accordance with a clinical trial protocol; a setting unit that sets a predetermined delivery schedule for each subject based on the clinical trial project; a delivery unit that delivers a confirmation message for the subject and a selective question regarding the survival confirmation of the subject based on the delivery schedule; an acquisition unit that acquires an answer to the question; and a management unit that manages the answer for each subject.

[0007] According to the present invention, by distributing messages and questions according to a distribution schedule set for each subject, obtaining answers to the questions, and managing them for each subject, it becomes possible to confirm the survival of subjects without making phone calls. As a result, it is possible to confirm survival efficiently without placing an excessive workload on the CRC or burdening the subjects.

[0008] Although this invention falls under the category of systems, it will produce similar functions and effects specific to other categories such as computers, methods, and programs.

[0009] According to the present invention, it is possible to efficiently confirm survival without placing an excessive workload on the CRC or burdening the subjects.

[0010] This diagram illustrates the overview of the Survival Confirmation Survey System 1, where 1(a) is an overview diagram of the entire system, and 1(b) is a diagram showing only the computer 10. This diagram shows the instruction configuration of the Survival Confirmation Survey System 1. This diagram shows a flowchart of the processing related to the generation of clinical trial projects and the setting of distribution schedules executed by the Survival Confirmation Survey System 1. This diagram schematically shows the UI displayed by the CRC terminal 3. This diagram schematically shows the UI displayed by the CRC terminal 3. This diagram schematically shows the custom input screen displayed by the CRC terminal 3. This diagram schematically shows the UI displayed by the CRC terminal 3. This diagram shows a flowchart of the processing related to the distribution of confirmation messages and questions, acquisition of answers, and management of answers executed by the Survival Confirmation Survey System 1. This diagram schematically shows the questions for subjects displayed by the subject terminal 5. This diagram schematically shows the questions for agents displayed by the subject terminal 5. This diagram shows a flowchart of the processing related to the generation of status lists and output of status lists executed by the Survival Confirmation Survey System 1. This diagram schematically shows the list of statuses for each subject displayed by the CRC terminal 3. This diagram schematically shows the distribution history and subject information displayed by the CRC terminal 3.

[0011] Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the attached drawings. In the following drawings, the same elements are denoted by the same numbers or reference numerals throughout the description of the embodiments.

[0012] [Overview and Device Configuration of Survival Confirmation System 1] Figure 1(a) is a block diagram illustrating the overview of Survival Confirmation System 1, and Figure 1(b) is a diagram illustrating the computer 10. Figure 2 is a diagram illustrating the overview of the instruction configuration of Survival Confirmation System 1. Referring to Figures 1 and 2, the components of Survival Confirmation System 1 will be described. Survival Confirmation System 1 is a system for confirming the survival of subjects (patients) in clinical trials, and comprises a computer 10, a CRC terminal 3 managed by a CRC, and a subject terminal 5 managed by the subject or the subject's representative (patient's family, etc.). Note that Survival Confirmation System 1 may include terminals and devices other than those described above.

[0013] CRC Terminal 3 is a terminal device managed and used by CRC, and is, for example, a terminal device such as a mobile phone, smartphone, tablet device, personal computer, laptop computer, or a wearable device such as a smartwatch, smart glasses, or HMD (Head Mounted Display).

[0014] The subject terminal 5 is a terminal device managed and used by the subject or their representative, and may include, for example, mobile phones, smartphones, tablet devices, personal computers, laptop computers, or wearable devices such as smartwatches, smart glasses, and HMDs.

[0015] Computer 10 is composed of, for example, a processor (CPU (Central Processing Unit), GPU (Graphics Processing Unit), RAM (Random Access Memory), ROM (Read Only Memory), etc.). Computer 10 includes a communication unit that performs data communication with the CRC terminal 3 and the subject terminal 5 via a network 8 such as a public telephone network, a storage unit having various types of storage, a project generation unit that generates a clinical trial project in accordance with the clinical trial protocol, a setting unit that sets a predetermined distribution schedule for each subject based on the clinical trial project, a distribution unit that distributes confirmation messages and multiple-choice questions for subjects and their representatives regarding the confirmation of the subject's survival based on the distribution schedule, an acquisition unit that obtains answers to the questions, and a management unit that manages the answers for each subject. Computer 10 may be implemented as a single computer, or as a cloud computer, as it is implemented as multiple computers. In this specification, a cloud computer may be a system that uses any computer scalably to perform a specific function, or a system that includes multiple functional modules to implement a certain system and allows users to freely combine those functions.

[0016] This section outlines the processing steps involved in the survival confirmation system 1's process for confirming the survival of subjects in clinical trials.

[0017] Computer 10 generates a clinical trial project in accordance with the clinical trial protocol (step S1). Computer 10 receives input of information necessary for generating a clinical trial project from the CRC terminal 3 via a predetermined UI (User Interface), and generates a clinical trial project in accordance with the clinical trial protocol based on the received input.

[0018] Computer 10 sets a predetermined distribution schedule for each subject based on the clinical trial project (step S2). Computer 10 sets a distribution schedule for each subject to deliver a message and multiple-choice questions regarding the subject's survival to the subject terminal 5 based on the clinical trial project.

[0019] Computer 10 delivers a confirmation message and multiple-choice questions for the subject regarding the subject's survival, based on the delivery schedule (step S3). Computer 10 delivers the confirmation message and questions to the subject terminal 5 at the timing based on the set delivery schedule. The subject terminal 5 receives this confirmation message and questions and displays them on its display.

[0020] Computer 10 obtains the answer to the question (step S4). The subject terminal 5 accepts input of the answer to the displayed question and transmits the received input to computer 10. Computer 10 receives this input and obtains the answer.

[0021] Computer 10 manages the responses for each subject (step S5). Computer 10 stores the acquired responses, linking them to the subject's identifier (ID, management number, name, etc.), and manages the responses for each subject.

[0022] The above is an overview of the processing steps performed by the survival confirmation survey system 1.

[0023] First, an overview of the processing steps performed by the survival confirmation survey system 1 in steps S1 and S2, including the generation of clinical trial projects and the setting of distribution schedules, will be explained with reference to Figure 3. This figure shows a flowchart of the clinical trial project generation process and distribution schedule setting process performed by the computer 10.

[0024] Computer 10 generates a clinical trial project in accordance with the clinical trial protocol (step S10). The clinical trial protocol is a "clinical trial protocol" or "research protocol" that describes the objectives, design, methods, statistical considerations, and organization of the research, including the clinical trial. The clinical trial protocol pertains to subjects whose survival is to be confirmed by the CRC. Computer 10 receives input from the CRC terminal 3 via a predetermined UI (see Figures 4 to 7) regarding the contents of the clinical trial project entered by the CRC (project name, questionnaire (questionnaire title, purpose, confirmation message (confirmation message for the subject, confirmation message for the agent, etc.), multiple-choice questions (multiple-choice questions for confirmation for the subject, multiple-choice questions for confirmation for the agent, etc.)), clinical trial sponsor, CRO (Contract Research Organization), project stakeholders, distribution settings (distribution cycle (reference date, period, etc.), allowance (period, distribution adjustment period, etc.)), etc.), and generates a clinical trial project based on the received input. Furthermore, computer 10 may generate a clinical trial project in accordance with the clinical trial protocol using a generation AI that has previously learned the information necessary for generating the clinical trial protocol and clinical trial project.

[0025] Based on Figures 4 to 7, the UI used when computer 10 receives input from the CRC during the generation of a clinical trial project will be explained. Figures 4 to 7 show the various UIs displayed by the CRC terminal 3.

[0026] Referring to Figure 4, the UI displayed by the CRC terminal 3 will be explained. In Figure 4, UI 20 is shown. UI 20 consists of a Project ID field 21, a Clinical Trial Protocol Number input field 22, a Project Name input field 23, a Questionnaire input field 24, a Clinical Trial Sponsor input field 25, a CRO input field 26, a Project Stakeholder input field 27, a Distribution Settings input field 28, and a Distribution Settings Addition Icon 29. The CRC terminal 3 accepts input from the CRC for each field and icon of UI 20. The Project ID field 21 is where the automatically generated Project ID is entered. The Clinical Trial Protocol Number input field 22 is where the CRC enters the Clinical Trial Protocol number. The Project Name input field 23 is where the CRC enters the Project Name. The Questionnaire input field 24 is where the CRC enters the Questionnaire Title and Create New Questionnaire. The Clinical Trial Sponsor input field 25 is where the CRC enters the Clinical Trial Sponsor. The CRO input field 26 is where the CRC enters the CRO information. The Project Stakeholder input field 27 is where the CRC enters the project stakeholders. The distribution settings input field 28 is where the distribution settings for confirmation messages and multiple-choice questions are entered. The CRC enters the corresponding information in each of the fields: the clinical trial protocol number input field 22, the project name input field 23, the questionnaire input field 24, the clinical trial sponsor input field 25, the CRO input field 26, and the project stakeholders input field 27, using direct input via a virtual keyboard, selection from pre-prepared options, voice input, etc. The distribution settings input field 28 is where the CRC enters the initial distribution settings, subsequent distribution settings, and allowance information. For the initial distribution settings, the CRC enters the period from the reference date (setting by day, setting by month, etc.) in the distribution settings input field 28. Furthermore, CRC inputs the following settings for subsequent deliveries in the delivery settings input field 28: the basis for the cycle (e.g., based on the previous specified date, based on the previous survival check date), and the period from the cycle basis date to the next specified date (e.g., set by day, set by month). In addition, CRC inputs the following settings for allowances in the delivery settings input field 28: the allowance period (e.g., allowance start date, allowance end date), and delivery adjustments from the allowance start date (e.g., set by day).When the CRC enters information in the survey input field 24, the CRC terminal 3 transitions the currently displayed UI 20 to the UI 40 shown in Figure 5 and displays UI 40. Also, when the CRC enters information in the project stakeholders input field 27, the CRC terminal 3 displays the names of the project stakeholders etc. via a pull-down menu, etc. (not shown) and accepts input into the pull-down cell. Furthermore, when the CRC enters the distribution setting addition icon 29, the CRC terminal 3 transitions the currently displayed UI 20 to the UI 60 shown in Figure 7 and displays UI 60.

[0027] When the CRC inputs a predetermined icon or other information (not shown), the CRC terminal 3 transmits the received input content for each field to the computer 10. The computer 10 receives this input content and generates a clinical trial project that conforms to the clinical trial protocol entered by the CRC.

[0028] Referring to Figure 5, the UI displayed by the CRC terminal 3 will be explained. In Figure 5, UI 40 is shown, which the user transitions to from UI 20 after the CRC has entered information in the questionnaire input field 24. UI 40 consists of a questionnaire field 41 and a questionnaire content field 42. The CRC terminal 3 accepts input from the CRC for each field of UI 40.

[0029] The questionnaire section 41 is a field where the CRC enters the content of a confirmation message for the subject or their representative to be delivered to the subject's terminal 5. The questionnaire section 41 consists of a questionnaire title input field 43, a first text input field 44, a second text input field 45, and a third text input field 46. The questionnaire title input field 43 is a field where the CRC enters the title of the questionnaire (corresponding to multiple-choice questions). The first text input field 44 is a field where the CRC enters the text for a message to be sent to the subject (a message via email, SMS (Short Message Service), SNS (Social Networking Service), etc.). The first text input field 44 is where the content including text prompting the subject to complete the questionnaire and a link to this questionnaire is entered. The second text input field 45 is a field where the CRC enters the text for a message to be sent to the representative (a message via email, SMS, SNS, etc.). The second text input field 45 is where text prompting the user to complete the survey and a link to this survey are entered. The third text input field 46 is where the CRC enters a message for the agent. The third text input field 46 is where text prompting the user to complete the survey and a link to this survey are entered. The CRC enters the corresponding content into each of the fields: the survey title input field 43, the first text input field 44, the second text input field 45, and the third text input field 46, using direct input via a virtual keyboard, selection from pre-prepared options, voice input, etc.

[0030] The questionnaire content field 42 is a field where the CRC enters the content of multiple-choice questions for the subject or the subject's representative to be delivered to the subject terminal 5. This questionnaire content field 42 is linked to the first text input field 44, the second text input field 45, and the third text input field 46. The questionnaire content field 42 consists of a subject questionnaire content field 47 for the subject and a representative questionnaire content field 48 for the subject's representative. The subject questionnaire content field 47 contains the content of the questionnaire corresponding to the link destination included in the first text input field 44, and the representative questionnaire content field 48 contains the content of the questionnaire corresponding to the link destination included in the second text input field 45 and the third text input field 46. The subject questionnaire content field 47 consists of a message input field 49, a question item field 50, and a custom field 51. The message input field 49 is a field where the CRC enters the text of a message prompting the subject to answer the multiple-choice questions. The question item field 50 is a field where pre-set question items (based on status such as alive, deceased, survival status unknown, etc.) are displayed. The custom field 51 is where the CRC enters information when adding a question item. When the CRC adds a new question item, they can set the question item and answer field (checkbox, radio button, text, date, etc.) by entering the addition icon present in the custom field 51 (see Figure 6). The agent questionnaire content field 48 consists of a message input field 52, a question item field 53, and a custom field 54. The message input field 52 is where the CRC enters the text of a message prompting the subject's agent to answer a multiple-choice question. The question item field 53 is where pre-set question items (based on status such as alive, deceased, survival status unknown, etc.) are displayed. The custom field 54 is where the CRC enters information when adding a question item. When the CRC adds a new question item, they can set the question item and answer field (checkbox, radio button, text, date, etc.) by entering the addition icon present in the custom field 51.

[0031] Referring to Figure 6, the custom input screen displayed by the CRC terminal 3 will be explained. Figure 6 is a schematic diagram showing the custom input screen displayed by the CRC terminal 3. In Figure 6, the custom input screen 55 is shown when the CRC sets up new questions and answer fields using the custom field 51. The custom input screen 55 consists of cells in which the CRC inputs the types of questions and answer fields (answer method, number of answers, number of items, name, etc.). The CRC sets up new questions and answer fields by selecting from pre-prepared options, directly inputting text, etc. for each cell. The CRC terminal 3 reflects the input received from the custom input screen 55 in the questionnaire content field 42.

[0032] Referring to Figure 7, the UI displayed by the CRC terminal 3 will be explained. In Figure 7, UI 60 is shown, which the CRC transitions to from UI 20 after entering the delivery setting addition icon 29. UI 60 consists of a delivery setting input field 61. The CRC terminal 3 accepts input from the CRC for each field of UI 60. The delivery setting input field 61 is where the CRC enters information regarding delivery settings and allowances from an arbitrary timing (nth time) onward. The CRC enters the following into the delivery setting input field 61 as the delivery setting for the nth time onward: the basis for the cycle (based on the previous specified date, based on the previous survival confirmation date, etc.), and the period from the cycle basis date to the next specified date (set by day, set by month, etc.). Furthermore, CRC inputs the following delivery settings related to the allowance in the delivery settings input field 61: the allowance period (allowance start date, allowance end date, etc.) and delivery adjustments from the allowance start date (settings by day, etc.).

[0033] The CRC terminal 3 receives input from the CRC for each UI and menu field shown in Figures 4 to 7, and transmits the received input to the computer 10 by accepting input for predetermined registration icons, etc. The computer 10 receives this input and generates a clinical trial project based on the input received by the CRC terminal 3.

[0034] Furthermore, the configuration of each UI is not limited to the examples described above and can be designed as appropriate.

[0035] Returning to Figure 3, the process continues. Computer 10 sets a confirmation message and multiple-choice questions for each subject (step S11). In the clinical trial project generated in step S10, Computer 10 associates the confirmation message (contents entered in the first text input field 44, the second text input field 45, and the third text input field 46) and the multiple-choice questions (contents entered in the questionnaire content field 42) received from the CRC terminal 3 with the subject's identifier, etc., and sets a confirmation message and multiple-choice questions for each subject. Here, Computer 10 sets not only the subject's identifier such as number, name, and telephone number, but also the delivery method (delivery destination (subject and agent, agent only, subject only, etc.), delivery method (SMS, email, etc.)), and information about the agent such as the agent's name, telephone number, email address, and delivery method to the agent. Computer 10 can also set other information (cycle reference date, remarks, etc.). Furthermore, the computer 10 can also be configured to set the method of delivering confirmation messages and multiple-choice questions to each subject as either manual delivery (the CRC directly delivers the confirmation message and multiple-choice questions to the relevant subject) or batch delivery (the CRC directly delivers the confirmation message and multiple-choice questions to multiple relevant subjects).

[0036] Computer 10 sets a delivery schedule for each subject (step S12). Based on the delivery settings received from the CRC terminal 3 (contents entered in the delivery setting input field 28 in Figure 4 and the delivery setting input field 61 in Figure 7), Computer 10 sets a delivery schedule for the subject's confirmation message and multiple-choice questions regarding the subject's survival, and for the subject's representative, in the clinical trial project generated by the processing in step S10. Computer 10 can determine these based on the reference date set for each subject. For each subject, Computer 10 sets the delivery schedule as follows: initial delivery settings, delivery settings for the second and subsequent deliveries, delivery settings for the nth and subsequent deliveries, the period from the reference date of the cycle to the next specified date, the allowance period, and delivery adjustments from the start of the allowance.

[0037] Computer 10 stores the settings (step S13). Computer 10 stores the confirmation messages and multiple-choice questions set for each subject, and the delivery schedule for these as settings.

[0038] The above is an overview of the clinical trial project generation process and the distribution schedule setting process.

[0039] Furthermore, the delivery schedule, confirmation message, and multiple-choice questions set by the computer 10 can be edited (modified, added, deleted, etc.) at any time. In this case, the CRC terminal 3 displays the UI shown by the processing in step S10 again, accepts input for editing each field to be edited on this UI, and sends the received edited content to the computer 10. The computer 10 receives this edited content, edits the set delivery schedule, confirmation message, and multiple-choice questions to match the edited content, and manages the edited settings for each subject.

[0040] Next, with reference to Figure 8, an overview of the processing steps performed by the survival confirmation survey system 1 in steps S3 to S5, including the distribution of confirmation messages and questions, acquisition of answers, and management of answers, will be explained. This figure shows a flowchart of the processing performed by the computer 10 for the distribution of confirmation messages and questions, the acquisition of answers, and the management of answers.

[0041] Computer 10 delivers a confirmation message and multiple-choice questions regarding the survival of the subject based on the delivery schedule (step S20). Computer 10 delivers the confirmation message and questions based on the set delivery schedule. Here, computer 10 sends the confirmation message and questions for the subject to the subject terminal 5 used by the subject based on the delivery schedule, and the subject terminal 5 receives the confirmation message and questions and displays them via a predetermined UI (see Figure 9). The method of delivering the confirmation message and multiple-choice questions is not particularly limited and can be email, SMS (Short Message Service), SNS (Social Networking Service), etc.

[0042] Referring to FIG. 9, the questions for the subject displayed on the subject terminal 5 will be described. This figure is a diagram schematically showing the questions for the subject displayed on the subject terminal 5. In this figure, a question 70 is shown. The question 70 is composed of a message field 71, a question content field 72, an answer field 73, and an answer icon 74. The content shown in this message field 71, question content field 72, and answer field 73 reflects what the CRC input in the subject questionnaire content field 47 in FIG. 5. The subject accesses the question 70 which is the link destination included in the confirmation message, and based on the content described in the question content field 72 of this question 70, selects an appropriate option from within the answer field 73 and inputs an answer to the question. Then, the subject makes an input to the answer icon 74 (such as tapping on the answer icon 74, voice input, etc.), and the subject terminal 5 transmits the selected option received as an input to the computer 10 as an answer. Note that the content of the answer field 73 is not limited to options and may be in other forms such as free response, date entry, etc. When the subject terminal 5 receives an input to the answer icon 74, it transmits the input content to the answer field 73 to the computer 10.

[0043] Here, when the content of the answer field 73 is a free response, the subject inputs a reply message to the question content in the question content field 72 (directly input using a virtual keyboard in a predetermined text box, voice input, etc.). Then, the subject makes an input to the answer icon 74, and the subject terminal 5 transmits the received reply message as an input to the computer 10.

[0044] Returning to FIG. 8, the continuation of the process will be described. The computer 10 acquires the answer (step S21). The subject terminal 5 transmits the received answer to the computer 10. The computer 10 receives the answer transmitted by the subject terminal 5 and acquires the answer.

[0045] If computer 10 fails to obtain a response, it may redistribute a confirmation message and multiple-choice questions according to a predetermined period (a number, such as one week) or a set allowance. The redistributed confirmation message and multiple-choice questions may be the same as those used when no response was obtained, or they may include additional information indicating that they are being redistributed. If computer 10 fails to obtain a response, it will redistribute the message a predetermined number of times. At this time, the link to the multiple-choice questions included in the confirmation message will remain valid until the next confirmation message is distributed, at which point it will become invalid. Furthermore, computer 10 will determine whether it is necessary to redistribute the confirmation message after a predetermined period has elapsed (e.g., 1 day, 2 days, 3 days, 4 days, etc.) following the last distribution of the distributed confirmation message. At this time, the link to the multiple-choice questions included in the last distributed confirmation message will become invalid. In addition, if the allowance is exceeded or no response is obtained, computer 10 will notify the CRC and notify the CRC of this fact, and will send a message prompting the manual distribution of the confirmation message.

[0046] Here, we will explain the case where the confirmation message and multiple-choice questions are delivered to a representative of the subject rather than the subject. If the computer 10 does not receive a response after a predetermined period (several days, a week, etc.) has elapsed, or if a representative is set in the delivery settings instead of the subject, the computer 10 delivers the confirmation message and multiple-choice questions to the subject terminal 5 used by the representative. Based on the delivery schedule, the computer 10 sends the confirmation message and questions for the representative to the subject terminal 5 used by the representative, and the subject terminal 5 receives these confirmation messages and questions and displays them via a predetermined UI (see Figure 10).

[0047] Referring to FIG. 10, the questions for the agent displayed on the subject terminal 5 will be described. This figure is a diagram schematically showing the questions for the agent displayed on the subject terminal 5. In this figure, a question 80 is shown. The question 80 is composed of a message field 81, a question content field 82, an answer field 83, and an answer icon 84. The content shown in this message field 81, question content field 83, and answer field 83 reflects what was input by the CRC in the agent questionnaire content field 48 in FIG. 5. The agent accesses the question 80 which is the link destination included in the confirmation message, and based on the content described in the question content field 82 of this question 80, selects an appropriate option from within the answer field 83 and inputs an answer to the question. Also, if the subject himself / herself has already died, the date of death is input. After that, the agent makes an input to the answer icon 84 (tapping on the answer icon 84, voice input, etc.), and the subject terminal 5 transmits the selected option that has received the input to the computer 10 as an answer. Note that the content of the answer field 83 is not limited to options and may be in other forms such as free response, date entry, etc. When the subject terminal 5 receives an input to the answer icon 84, it transmits the input content for this answer field 83 (including the date of death if the subject has already died) to the computer 10.

[0048] Here, when the content of the answer field 83 is a free response, the agent inputs a reply message to the question content in the question content field 82 (directly input using a virtual keyboard in a predetermined text box, voice input, etc.). After that, the agent makes an input to the answer icon 84, and the subject terminal 5 transmits the received reply message to the computer 10.

[0049] Note that the method of obtaining the reply message and the answer may use email, SMS, SNS, etc. and is not particularly limited.

[0050] Returning to Figure 8, let's continue explaining the process. Computer 10 manages the responses for each subject (step S22). Computer 10 associates the acquired responses with the subject's identifier, stores them for each subject, and manages them. At this time, Computer 10 also stores and manages for each subject the date the response was acquired, whether it was the subject themselves or an agent, and other information about the acquisition status of the response. Furthermore, Computer 10 also stores and manages for each subject other than the responses, such as the delivery history of confirmation messages and multiple-choice questions sent in the past. Computer 10 manages the status of subjects from whom responses were obtained as "survival confirmed," and manages the status of subjects from whom responses were not obtained as "survival status unknown." For subjects managed as "survival status unknown," Computer 10 can also output a notification (a predetermined message, etc.) to the CRC terminal 3 prompting the CRC to perform a survival check on that subject.

[0051] The above is an overview of the processes for sending confirmation messages and questions, obtaining answers, and managing answers.

[0052] The survival confirmation survey system 1 can also be configured to manage EDC (Electronic Data Capture) input task checks and progress based on the responses of each subject managed by the processing in step S22.

[0053] Furthermore, the survival confirmation survey system 1 can also be configured to visualize the survival confirmation results, based on the responses of each subject being managed, in real time using graphs, tables, etc., while being color-barrier-free.

[0054] Next, an overview of the processing steps when the survival confirmation survey system 1 generates a status list will be explained with reference to Figure 11. This figure is a flowchart showing the status list generation process and the status list output process executed by the computer 10.

[0055] Computer 10 generates a list of statuses for each subject (step S30). The statuses include the status of obtaining answers to the distributed multiple-choice questions and the status of confirming the subject's survival. For example, if an answer has been received, the status is "Answer obtained (subject / agent)" or "Awaiting confirmation (Answer not obtained (subject / agent))." If the status is related to survival, the status is "Confirmed," "Confirmation not possible," "Confirming in progress," or "Distribution failure." Computer 10 generates a list of statuses for each subject based on the management details for each subject. Specifically, Computer 10 generates a status for each subject based on the distribution status of the distributed confirmation message and multiple-choice questions (subject / agent), the status of obtaining answers to the questions (subject / agent), and / or the survival status. Computer 10 then compiles this status for each subject into a predetermined format (table format, etc.) to generate a list of statuses for each subject.

[0056] Computer 10 outputs a list (step S31). Computer 10 transmits the generated list of statuses for each subject to CRC terminal 3 based on a request from CRC terminal 3. CRC terminal 3 receives this list and displays it on its display unit via a predetermined UI (see Figure 12).

[0057] Referring to Figure 12, the list of subject statuses displayed by the CRC terminal 3 will be explained. This figure schematically shows the list of subject statuses displayed by the CRC terminal 3. In this figure, lists 90 to 93 are shown. These lists 90 to 93 are for cases where the status is "survival confirmed". List 90 summarizes the subject number, subject name, previous delivery date, verifier, and clinical trial protocol number for each subject with a "survival confirmed" status. List 91 summarizes the subject number, subject name, previous delivery date, verifier, and clinical trial protocol number for each subject with a "survival confirmation in progress" status. List 92 summarizes the survey period, subject number, subject name, and clinical trial protocol number for each subject with a "survival not confirmed" status. List 93 summarizes the subject number, subject name, status (reason for message delivery failure (not activated, reference date not entered, etc.)), and clinical trial protocol number for each subject with a "delivery failure" status. In lists 90-93, the subject number is linked to the delivery history of past confirmation messages and subject information (personal information, agent information, etc.). When the CRC performs an input operation (tap, etc.) on this subject number, the CRC terminal 3 transitions the display to the delivery history or subject information (see Figure 13).

[0058] The contents of the list are not limited to the example described above and can be designed as appropriate. Furthermore, the list can be generated and output even for statuses other than "survival confirmation."

[0059] Referring to Figure 13, the delivery history and subject information displayed by the CRC terminal 3 will be explained. The figure schematically shows the delivery history and subject information displayed by the CRC terminal 3. In the figure, UI 100 is shown. UI 100 consists of a subject information field 101, a status field 102, and a delivery history field 103. The subject information field 101 displays subject information linked to the subject number from which the transition originated, as well as information regarding the message delivery settings. The status field 102 displays information regarding the status of survival confirmation and the method of survival confirmation. The delivery history field 103 displays information regarding the delivery status of the message. In addition, although not shown in the figure, the delivery history field 103 can also display the answers to the multiple-choice questions obtained from this subject. When the CRC terminal 3 displays the answers in UI 100, it may display the answers for each message displayed in the delivery history using a pull-down menu or by other means. When the CRC terminal 3 receives input for a subject number in lists 90 to 93, it transitions to UI 100, which displays subject information and message delivery settings associated with the received subject number, and displays these.

[0060] Furthermore, the configuration of UI100 is not limited to the examples described above and can be designed as appropriate.

[0061] The above is an overview of the status list generation process and the status list output process.

[0062] The above is an overview of the Survival Confirmation Survey System 1. This Survival Confirmation Survey System 1 does not impose an excessive workload on the CRC, does not burden the subjects, and makes it possible to efficiently confirm survival.

[0063] The means and functions described above are realized by a computer (including the CPU, information processing unit, and various terminals) reading and executing a predetermined program. The program may be provided, for example, via a network from the computer (SaaS: Software as a Service) or as a cloud service. Alternatively, the program may be provided in a form recorded on a computer-readable recording medium. In this case, the computer reads the program from the recording medium, transfers it to an internal or external recording device, records it, and executes it. Alternatively, the program may be pre-recorded on a recording device (recording medium) and provided to the computer from that recording device via a communication line.

[0064] Although embodiments of the present invention have been described above, the present invention is not limited to the embodiments described above. Furthermore, the effects described in the embodiments of the present invention are merely a list of the most preferred effects arising from the present invention, and the effects of the present invention are not limited to those described in the embodiments of the present invention.

[0065] A first aspect disclosed in this embodiment provides a survival confirmation survey system for confirming the survival of subjects in a clinical trial, comprising: a project generation unit that generates a clinical trial project in accordance with the clinical trial protocol; a setting unit that sets a predetermined distribution schedule for each subject based on the clinical trial project; a distribution unit that distributes a confirmation message and multiple-choice questions for the subject regarding the survival confirmation of the subject based on the distribution schedule; an acquisition unit that acquires answers to the questions; and a management unit that manages the answers for each subject.

[0066] A second aspect disclosed in this embodiment provides a survival confirmation survey system according to the first aspect, wherein if the distribution unit is unable to obtain the response, or if the distribution schedule has been set in advance, it distributes a confirmation message for a representative regarding the survival confirmation of the subject and a set of multiple-choice questions.

[0067] A third aspect disclosed in this embodiment provides a survival confirmation survey system according to the first aspect, wherein the setting unit sets a predetermined allowance, and the distribution unit distributes a confirmation message and a selection question for the subject based on the allowance.

[0068] A fourth aspect disclosed in this embodiment provides a survival confirmation survey system according to the first aspect, further comprising: a list generation unit that generates a list of statuses indicating the status of obtaining the responses; and a list output unit that outputs the list.

[0069] A fourth aspect disclosed in this embodiment provides a survival confirmation survey system according to the first embodiment, further comprising: an answer output unit for outputting the answer.

[0070] 1 Survival Confirmation Survey System 3 CRC Terminal 5 Subject Terminal 8 Network 10 Computer 20 UI 21 Project ID Field 22 Clinical Trial Protocol Number Input Field 23 Project Name Input Field 24 Questionnaire Input Field 25 Clinical Trial Sponsor Input Field 26 CRO Input Field 27 Project Stakeholder Input Field 28 Distribution Settings Input Field 29 Distribution Settings Add Icon 40 UI 41 Questionnaire Field 42 Questionnaire Content Field 43 Questionnaire Title Input Field 44 First Text Input Field 45 Second Text Input Field 46 Third Text Input Field 47 Subject Questionnaire Content Field 48 Agent Questionnaire Content Field 49 Message Input Field 50 Questionnaire Item Field 51 Custom Field 52 Message Input Field 53 Questionnaire Item Field 54 Custom Field 55 Custom Input Screen 60 UI 61 Distribution Settings Input Field 70 Question 71 Message Field 72 Question field 73 Answer field 74 Answer icon 80 Question 81 Message field 82 Question field 83 Answer field 84 Answer icon 90 List 91 List 92 List 93 List 100 UI 101 Subject information field 102 Status field 103 Delivery history field

Claims

1. A survival confirmation survey system for confirming the survival of subjects in a clinical trial, comprising: a project generation unit that generates a clinical trial project in accordance with the clinical trial protocol; a setting unit that sets a predetermined distribution schedule for each subject based on the clinical trial project; a distribution unit that distributes confirmation messages and multiple-choice questions for subjects regarding the survival confirmation of the subjects based on the distribution schedule; an acquisition unit that acquires answers to the questions; and a management unit that manages the answers for each subject.

2. The survival confirmation survey system according to claim 1, wherein the distribution unit distributes a confirmation message for a representative regarding the survival confirmation of the subject and a set of multiple-choice questions if it is unable to obtain the response or if the distribution schedule has been set in advance.

3. The survival confirmation survey system according to claim 1, wherein the setting unit sets a predetermined allowance, and the distribution unit distributes a confirmation message and a selection-type question for the subject based on the allowance.

4. The survival confirmation survey system according to claim 1, further comprising: a list generation unit that generates a list of statuses indicating the status of obtaining the aforementioned responses; and a list output unit that outputs the aforementioned list.

5. The survival confirmation survey system according to claim 1, further comprising: an answer output unit that outputs the aforementioned answer.

6. A computer for confirming the survival of subjects in a clinical trial, comprising: a project generation unit that generates a clinical trial project in accordance with the clinical trial protocol; a setting unit that sets a predetermined distribution schedule for each subject based on the clinical trial project; a distribution unit that distributes confirmation messages and multiple-choice questions for subjects regarding the confirmation of the subject's survival based on the distribution schedule; an acquisition unit that acquires answers to the questions; and a management unit that manages the answers for each subject.

7. A survival confirmation survey method performed by a computer for confirming the survival of subjects in a clinical trial, comprising: a step of generating a clinical trial project in accordance with the clinical trial protocol; a step of setting a predetermined distribution schedule for each subject based on the clinical trial project; a step of distributing a confirmation message and multiple-choice questions for the subject regarding the confirmation of the subject's survival based on the distribution schedule; a step of obtaining answers to the questions; and a step of managing the answers for each subject.

8. A computer-readable program for causing a computer used to verify the survival of subjects in a clinical trial to perform the following steps: generating a clinical trial project in accordance with the clinical trial protocol; setting a predetermined distribution schedule for each subject based on the clinical trial project; distributing a confirmation message and multiple-choice questions for the subject regarding the verification of the subject's survival based on the distribution schedule; obtaining answers to the questions; and managing the answers for each subject.

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