Case report form management method, device and equipment

Abstract

The embodiments of this specification disclose a method, device and equipment for managing case report forms. The scheme may include: when managing the case report forms to be generated in the clinical trial project, the project information of the clinical trial project and the form identification information of the case report form to be generated may be obtained, so as to determine the first similarity between each case report form template and the case report form to be generated based on the project information and the form identification information; and then the case report form template most similar to the case report form to be generated may be automatically identified; by using the existing form information in the most similar case report form template to generate the case report form to be generated, the form content of the case report form that the user needs to design may be reduced, which is conducive to improving the management convenience and efficiency of the case report form.

Description

Technical Field

[0001] The present application relates to the technical field of clinical trial data management, and in particular to a case report form management method, device and equipment. Background Art

[0002] Case Report Form (CRF) refers to a document that needs to be designed in accordance with the requirements of the clinical trial protocol and is used to record all information of each subject during the clinical trial. At present, when conducting clinical trial projects, professionals who are familiar with the preparation of case report forms are usually required to redesign the case report form for the clinical trial project based on their personal experience, which is inconvenient to operate, thus affecting the convenience and efficiency of the management of case report forms.

[0003] Based on this, how to improve the management convenience and efficiency of case report forms has become a technical problem that needs to be solved urgently. Summary of the invention

[0004] The embodiments of this specification provide a case report form management method, device and equipment, which can improve the management convenience and efficiency of case report forms.

[0005] To solve the above technical problems, the embodiments of this specification are implemented as follows:

[0006] A case report form management method provided in an embodiment of this specification includes:

[0007] Obtain project information of clinical trial projects;

[0008] Obtaining form identification information of a case report form to be generated in the clinical trial project;

[0009] Determining a first similarity between each case report form template and the case report form to be generated according to the project information and the form identification information;

[0010] Based on the case report form template corresponding to the first maximum similarity value, a target case report form corresponding to the form identification information is generated.

[0011] The embodiment of this specification provides a case report form management device, including:

[0012] The first acquisition module is used to acquire project information of the clinical trial project;

[0013] A second acquisition module is used to acquire form identification information of a case report form to be generated in the clinical trial project;

[0014] A first determination module, configured to determine a first similarity between each case report form template and the case report form to be generated according to the project information and the form identification information;

[0015] A first generating module is configured to generate a target case report form corresponding to the form identification information based on the case report form template corresponding to the first maximum similarity value.

[0016] A case report form management device provided in an embodiment of this specification includes:

[0017] at least one processor; and,

[0018] a memory communicatively connected to the at least one processor; wherein,

[0019] The memory stores instructions executable by the at least one processor, the instructions being executed by the at least one processor to enable the at least one processor to:

[0020] Obtain project information of clinical trial projects;

[0021] Obtaining form identification information of a case report form to be generated in the clinical trial project;

[0022] Determining a first similarity between each case report form template and the case report form to be generated according to the project information and the form identification information;

[0023] Based on the case report form template corresponding to the first maximum similarity value, a target case report form corresponding to the form identification information is generated.

[0024] At least one embodiment provided in this specification can achieve the following beneficial effects:

[0025] When designing a case report form to be generated in a clinical trial project, the project information of the clinical trial project and the form identification information of the case report form to be generated can be obtained, so as to determine the first similarity between each case report form template and the case report form to be generated based on the project information and the form identification information; and then, based on the case report form template corresponding to the maximum value of the first similarity, a target case report form corresponding to the form identification information can be generated. This solution can automatically identify the case report form template that is most similar to the case report form to be generated. Therefore, by using the existing form information in the most similar case report form template to design the target case report form, the content required to be designed for the target case report form can be reduced, which is conducive to improving the management convenience and efficiency of the case report form. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the embodiments of this specification or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0027] Figure 1 This is a schematic diagram of an application scenario of a case report form management method in an embodiment of this specification;

[0028] Figure 2 A flowchart of a case report form management method provided in an embodiment of this specification;

[0029] Figure 3 A schematic diagram of a first page displayed in a terminal device provided in an embodiment of this specification;

[0030] Figure 4 The embodiments of this specification provide corresponding to Figure 2 A structural schematic diagram of a case report form management device;

[0031] Figure 5 The embodiments of this specification provide corresponding to Figure 2 A structural schematic diagram of a case report form management device. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical solutions and advantages of one or more embodiments of this specification clearer, the technical solutions of one or more embodiments of this specification will be clearly and completely described below in combination with the specific embodiments of this specification and the corresponding drawings. Obviously, the described embodiments are only part of the embodiments of this specification, not all of the embodiments. Based on the embodiments in this description, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of one or more embodiments of this specification.

[0033] The technical solutions provided by the embodiments of this specification are described in detail below in conjunction with the accompanying drawings.

[0034] In the prior art, when a clinical trial project needs to be carried out, professionals familiar with the preparation of case report forms are usually required to redesign the case report form for the clinical trial project based on their personal experience to determine the form information that should be included in the case report form, such as case demographic information (date of birth, gender, height, etc.), case medical information (such as the date of first pathological diagnosis, clinical stage, whether there is a history of tumor surgery, etc.), case medication information (such as drug name, dosage frequency, dosage unit, etc.), etc. The operation is relatively complicated and requires a lot of manpower.

[0035] Based on this, people have begun to create and store case report form templates, so that when a target case report form needs to be generated for a clinical trial project, professionals familiar with case report form production can manually screen out more suitable case report form templates based on their personal experience, and generate the target case report form based on the manually screened case report form template.

[0036] Although this solution can save some manpower, it still requires professionals to check and verify the case report form templates one by one to determine the case report form template to be used. Not only is the operation inconvenient, but the applicability and practicality of the determined case report template to be used completely depend on the operator's carefulness, thus affecting the convenience and efficiency of the management of the case report form.

[0037] In order to solve the defects in the prior art, this solution provides the following embodiments:

[0038] Figure 1 This is a schematic diagram of an application scenario of a case report form management method in an embodiment of this specification.

[0039] like Figure 1 As shown, when user 101 needs to manage the case report forms to be generated in the clinical trial project, the project information of the clinical trial project and the form identification information of the case report forms to be generated in the clinical trial project can be input into the terminal device 102; thereby, the terminal device 102 can obtain the project information and the form identification information.

[0040] The database 103 stores various pre-established case report form templates. The terminal device 102 can obtain relevant information of each case report form template from the database 103, and determine the first similarity between each case report form template and the case report form to be generated based on the relevant information of each case report form template obtained and the project information and the form identification information obtained in the early stage.

[0041] The terminal device 102 may also set the case report form template corresponding to the first maximum similarity value as the initial form of the case report form to be generated. The user 101 may add, modify and overwrite the content in the initial form at the terminal device 102 according to actual conditions to generate the required target case report form.

[0042] Figure 1In the solution, since the case report form template most similar to the case report form to be generated can be automatically identified, the target case report form can be designed by using the existing form information in the most similar case report form template to reduce the content required to be designed for the target case report form, which is conducive to improving the management convenience and efficiency of the case report form.

[0043] Next, a case report form management method provided in the embodiment of the specification will be specifically described with reference to the accompanying drawings:

[0044] Figure 2 The following is a flowchart of a case report form management method provided in an embodiment of this specification. From a program perspective, the execution subject of the process can be a terminal device, or an application installed on the terminal device. Figure 2 As shown, the process may include the following steps:

[0045] Step 202: Obtain project information of the clinical trial project.

[0046] In the embodiments of the present specification, the project information of a clinical trial project may be information used to indicate the project content, project purpose, etc. of the clinical trial project. For example, the project information of a clinical trial project may include but is not limited to: project staging information, treatment field information, indication information, etc. of the clinical trial project.

[0047] Step 204: Obtain form identification information of the case report form to be generated in the clinical trial project.

[0048] In the embodiments of this specification, when setting a case report form for a clinical trial project, the user can first determine the form identification information of each case report form to be generated, so as to design a case report form corresponding to each form identification information. The form identification information of the case report form to be generated can be either the name information of the case report form to be generated or information used to indicate certain characteristics of the case report form.

[0049] Specifically, if the form identification information of the case report form to be generated is the name information of the case report form to be generated, the naming rule for the case report form can be determined according to the application scenario of the clinical trial project, and the name information that complies with the naming rule is generated for the case report form to be generated. For example, when the application scenario is a domestic scenario, the naming rule can be a string containing Chinese characters. Based on this, the name information for the case report form to be generated can be "XX Clinical Research Project Case Report Form", "XX Clinical Research Project Female Case Report Form", etc.

[0050] If the form identification information of the case report form to be generated is information used to represent certain characteristics of the case report form, then the form identification information may be label information set for the case report form to be generated. For example, the form identification information may include but is not limited to: case gender label (such as female, or male), organ classification label (such as heart, liver), disease classification label (such as hypertension, hyperglycemia), etc.

[0051] In actual applications, users can submit the form identification information of the case report form to be generated in the clinical trial project in a matrix form. The matrix form can not only carry the form identification information of the case report form to be generated, but also carry the visit structure information of the case report form to be generated, so as to facilitate the subsequent management of the generated target case report form.

[0052] Step 206: Determine a first similarity between each case report form template and the case report form to be generated according to the project information and the form identification information.

[0053] In the embodiments of this specification, the terminal device can obtain various pre-made case report form templates, wherein the case report form templates can include case report forms designed in other clinical trial projects, and can also include more general case report forms pre-designed by users, without specific limitation.

[0054] In actual applications, the contents (i.e., form template information) included in each case report form template are usually not exactly the same, but for ease of understanding, examples are given of the form template information that may be included in the case report form template. For example, the form template information may include, but is not limited to: form name information, field information in the form (e.g., field name, field attributes, field length, field type, dictionary item, etc.), prompt text in the form, multiple record information in the form, etc. Among them, the multiple record information in the form can be used to indicate multiple field information belonging to the same information type, for example, a multi-record information can be used to indicate that the blood routine test results contain multiple field information such as red blood cell count, white blood cell count, platelet count, etc.

[0055] The terminal device can use the project information and the form identification information obtained in steps 202-204 as the form information of the case report form to be generated, so that after obtaining the form template information of each case report form template, the similarity between the form template information of each case report form template and the form information of the case report form to be generated can be automatically calculated to determine the first similarity between each case report form template and the case report form to be generated. Generally, the greater the first similarity, the fewer the differences between the case report form template and the case report form to be generated, and the smaller the first similarity, the more the differences between the case report form template and the case report form to be generated.

[0056] Step 208: Based on the case report form template corresponding to the first maximum similarity value, generate a target case report form corresponding to the form identification information.

[0057] In the embodiment of the present specification, since the case report form template corresponding to the first maximum similarity value is the case report form template with the least difference points with the case report form to be generated, when the case report form to be generated is prepared based on the case report form template corresponding to the first maximum similarity value, the user can obtain the desired target case report form through the least modification operation. Based on this, the user can use the case report form template corresponding to the first maximum similarity value automatically determined by the terminal device to generate the target case report form corresponding to the form identification information.

[0058] Figure 2 In the method, since the terminal device can automatically identify the case report form template that is most similar to the case report form to be generated, the user can use the existing form information in the most similar case report form template to design the target case report form, so as to reduce the content that needs to be designed for the target case report form, which is conducive to improving the management convenience and efficiency of the case report form.

[0059] based on Figure 2 The method in this specification also provides some specific implementation plans of the method, which are described below.

[0060] In the embodiment of this specification, step 206: determining the first similarity between each case report form template and the case report form to be generated according to the project information and the form identification information may specifically include:

[0061] For each case report form template, the form template information contained in the case report form template is obtained.

[0062] A first similarity between the form template information and the case report form information to be generated is calculated; the case report form information to be generated includes the project information and the form identification information.

[0063] In the embodiments of this specification, the technical principles used to calculate the first similarity between each case report form template and the case report form to be generated are generally the same. Therefore, for ease of understanding, the process of calculating the first similarity between a single case report form template and the case report form to be generated is explained.

[0064] In actual applications, since the form template information and the case report form information to be generated usually contain multiple information items (such as field information, multiple record information, etc.), the degree of matching between the various information items is usually proportional to the first similarity between the form template information and the case report form information to be generated.

[0065] Based on this, calculating the first similarity between the form template information and the case report form information to be generated may specifically include:

[0066] Each information item contained in the case report form information to be generated is matched with each information item contained in the form template information to obtain an information item matching result.

[0067] According to the information item matching results corresponding to each information item in the case report form information to be generated, the matching degree corresponding to each information item in the case report form information to be generated is determined; the matching degree corresponding to any information item in the case report form information to be generated is used to reflect the matching degree between any one information item and the information item in the form template information.

[0068] According to the matching degree corresponding to each information item in the case report form information to be generated, a first similarity between the case report form information to be generated and the form template information is determined.

[0069] In the embodiments of this specification, when matching each information item contained in the case report form information to be generated with each information item contained in the form template information, there are multiple implementation methods. For example, implementation method 1 uses the exact matching technology to perform matching processing; implementation method 2 uses the fuzzy matching technology to perform matching processing.

[0070] Among them, exact matching can refer to a method of generating a matching result based on the search result by searching for an information item that is completely consistent with the target information item. The two information items that successfully match the information item must be completely consistent. For example, assuming that the target information item is "symptoms of hypertension", the information item that can successfully match the target information item is "symptoms of hypertension", while the information item "high blood pressure" fails to match the target information item accurately.

[0071] Fuzzy matching can refer to the method of automatically splitting the target information item to obtain the search term, searching for the information item containing the search term, and performing a logical AND operation to generate the matching result. The two information items that successfully fuzzy match are not necessarily completely identical. Usually, the two information items only need to contain some of the same search terms, or the two information items can contain search terms with the same or similar meanings. For example, assuming that the target information item is "hypertension symptoms", the information item "high blood pressure" can be successfully fuzzy matched with the target information item.

[0072] Based on this, when matching the various information items contained in the case report form information to be generated with the various information items contained in the form template information, precise matching can be performed first, and then fuzzy matching can be performed to improve the accuracy of the matching degree between the information items determined based on the matching results.

[0073] Thus, each information item contained in the case report form information to be generated is matched with each information item contained in the form template information to obtain an information item matching result, which may specifically include:

[0074] Accurately match each information item contained in the case report form information to be generated with each information item contained in the form template information to obtain an accurate matching result of the information items.

[0075] According to the information item matching results corresponding to the information items in the case report form information to be generated, determining the matching degree corresponding to the information items in the case report form information to be generated may specifically include:

[0076] According to the precise matching result of the information item, each first information item in the case report form information to be generated is determined; the precise matching result corresponding to the first information item indicates a successful match.

[0077] It is determined that the matching degree corresponding to each of the first information items is 100%.

[0078] In the embodiment of the present specification, if the exact matching result corresponding to the information item (i.e., the first information item) in the case report form information to be generated indicates a successful match, it can be indicated that the form template information contains an information item that is completely consistent with the information item, so that the matching degree corresponding to the information item can be determined to be 100%. For other information items (i.e., the second information item) in the case report form information to be generated, fuzzy matching is required to determine the matching degree based on the fuzzy matching result.

[0079] Thus, each information item contained in the case report form information to be generated is matched with each information item contained in the form template information to obtain an information item matching result, which may also include:

[0080] Fuzzy matching is performed on each second information item in the case report form information to be generated and the information item in the form template information to obtain an information item fuzzy matching result; the information item exact matching result corresponding to the second information item indicates a matching failure.

[0081] Correspondingly, determining the matching degree corresponding to each information item in the case report form information to be generated according to the information item matching result corresponding to each information item in the case report form information to be generated may also include:

[0082] According to the fuzzy matching result of the information item, each third information item in the case report form information to be generated is determined; the fuzzy matching result of the information item corresponding to the third information item indicates that the matching fails.

[0083] It is determined that the matching degree corresponding to each of the third information items is 0%.

[0084] In an embodiment of the present specification, if the exact match result corresponding to the information item (i.e., the third information item) in the case report form information to be generated indicates a match failure, it may mean that the form template information does not contain an information item similar to the information item, and thus it may be determined that the matching degree corresponding to the information item is 0%.

[0085] In the embodiments of the present specification, the precise matching result of the information item and the fuzzy matching result of the information item can not only be used to indicate whether the match is successful, but also to indicate the successful matching relationship between the information items in the case report form information to be generated and the information items in the form template information.

[0086] In practical applications, one information item in the form template information can be allowed to correspond to multiple successful matching relationships, or one information item in the form template information can correspond to at most one successful matching relationship, and there is no specific limitation on this. For the first case, all the information items in the form template information can be used for fuzzy matching, and for the second case, if some of the information items in the form template information are accurately matched with the information items in the case report form information to be generated, it is necessary to remove these information items from all the information items in the form template information, and then use the remaining information items in the form template information for fuzzy matching.

[0087] In the embodiment of the present specification, the matching degree corresponding to the fuzzy matched information item (ie, the fourth information item) in the case report form information to be generated can also be determined based on the matching success relationship information between the information items indicated by the fuzzy matching result of the information items.

[0088] Specifically, determining the matching degree corresponding to each information item in the case report form information to be generated according to the information item matching result corresponding to each information item in the case report form information to be generated may also include:

[0089] According to the fuzzy matching results of the information items, each fourth information item in the case report form information to be generated is determined; the fuzzy matching result of the information item corresponding to the fourth information item indicates a successful match, and the fuzzy matching result of the information item corresponding to the fourth information item is also used to indicate the target information item in the form template information that is successfully fuzzy matched with the fourth information item.

[0090] For each of the fourth information items, an edit distance between the fourth information item and the target information item is calculated.

[0091] A maximum edit distance value is determined from the edit distances corresponding to the fourth information items.

[0092] For each of the fourth information items, a difference between the maximum edit distance and the edit distance corresponding to the fourth information item is calculated, and a quotient of the difference and the maximum edit distance is calculated to obtain a matching degree corresponding to the fourth information item.

[0093] In the embodiments of this specification, the edit distance is an indicator used to measure the similarity between two character sequences. Generally speaking, the edit distance refers to the minimum number of single-character editing operations required to convert one character sequence into another character sequence between two character sequences, wherein a single-character editing operation may include replacing one character with another, inserting a character, deleting a character, etc. For example, when converting "hypertension symptoms" to "high blood pressure", the words "high" and "symptom" in "hypertension symptoms" can be deleted, and the word "shape" can be changed to "high". It can be seen that the corresponding minimum number of single-character editing operations is 3, that is, the edit distance between "hypertension symptoms" and "high blood pressure" is 3.

[0094] In the embodiments of the present specification, generally, the smaller the edit distance corresponding to the fourth information item in the case report form information to be generated, the closer the fourth information item is to the information item in the form template information that is successfully fuzzy matched with the fourth information item (i.e., the target information item), thereby indicating that the degree of matching corresponding to the fourth information item is greater.

[0095] Since the case report form information to be generated usually contains multiple fourth information items that have been successfully fuzzy matched, in order to facilitate the use of the same standard to measure the matching degree corresponding to each fourth information item, the maximum value of the edit distance corresponding to each fourth information item can be determined, and the quotient of the difference between the maximum edit distance and the edit distance corresponding to each fourth information item and the maximum edit distance is taken as the matching degree corresponding to each fourth information item.

[0096] For ease of understanding, an example is given for illustrating the process of calculating the matching degree corresponding to each fourth information item.

[0097] Assume that the fourth information items that are fuzzily matched successfully in the case report form information to be generated include: "high blood pressure", "cardiovascular and cerebrovascular diseases", and "sleep apnea hypopnea syndrome", and the target information items in the form template information that are fuzzily matched successfully with the above fourth information items are: "hypertension", "heart", and "irregular snoring during sleep". Through calculation, the minimum number of single-character editing operations required to convert each target information item into each fourth information item are: 2, 5, and 10, respectively, that is, the editing distances corresponding to the above fourth information items are 2, 5, and 10, respectively. Since the maximum value of the editing distance is 10, the matching degrees corresponding to the above fourth information items are: (10-2) / 10=80%, (10-5) / 10=50%, and (10-10) / 10=0%, respectively.

[0098] According to the above embodiment, it is possible to calculate the matching degree corresponding to each information item in the case report form information to be generated. At this time, the average value of the matching degree corresponding to each information item in the case report form information to be generated can be calculated as the first similarity between the case report form information to be generated and the form template information, thereby obtaining the first similarity between the case report form template and the case report form to be generated.

[0099] Specifically, the matching degrees corresponding to each information item in the case report form information to be generated can be summed to obtain the sum of the matching degrees, and then the quotient of the sum of the matching degrees and the number of information items in the case report form information to be generated can be calculated to obtain the first similarity between the case report form information to be generated and the form template information.

[0100] For ease of understanding, an example is given for illustrating the process of calculating the first similarity between the case report form information to be generated and the form template information.

[0101] Assuming that the case report form information to be generated contains 3 information items with a matching degree of 100%, 4 information items with a matching degree of 0%, and 3 information items with matching degrees of 80%, 50% and 0% respectively, then the first similarity = [(3*100%) + (1*80% + 1*50% + 1*0%) + (4*0%)] / (3+3+4) = 43%.

[0102] In actual applications, since the matching degree of information items of different information types in the case report form information to be generated may not affect the first similarity between the case report form information to be generated and the form template information, it is also possible to set a preset weight corresponding to each information type to calculate a first similarity with better accuracy based on the preset weight.

[0103] That is, determining the first similarity between the case report form information to be generated and the form template information according to the matching degree corresponding to each information item in the case report form information to be generated may specifically include:

[0104] For any information item in the case report form information to be generated, the product of the matching degree corresponding to the any information item and the preset weight of the information type to which the any information item belongs is calculated to obtain the weighted matching degree corresponding to the any information item.

[0105] The sum of the weighted matching degrees corresponding to each information item in the case report form information to be generated is calculated to obtain a first similarity between the case report form information to be generated and the form template information.

[0106] For ease of understanding, the process of calculating the first similarity between the case report form information to be generated and the form template information is illustrated with reference to the example data in the above embodiment.

[0107] Assume that the information items such as "high blood pressure", "cardiovascular and cerebrovascular diseases", and "sleep apnea hypopnea syndrome" in the case report form information to be generated belong to the three information types of "project information", "CRF label", and "CRF content", and the preset weights corresponding to these three information types are 20%, 10%, and 70%. If the three information items with a matching degree of 100% in the case report form information to be generated belong to the information type of "project information", and the four information items with a matching degree of 0% in the case report form information to be generated belong to the information type of "CRF content". Then the first similarity = [(3*100%*20%) + (1*80%*20% + 1*50%*10% + 1*0%*70%) + (4*0%*70%)] / (3+3+4) = 8.1%.

[0108] In the embodiment of the present specification, although the case report form template that is most similar to the case report form to be generated can be determined in step 208, the user usually cannot directly use the case report form template as the target case report form corresponding to the form identification information, but needs to modify and improve the case report form template according to the actual situation to obtain the target case report form corresponding to the form identification information that meets the actual needs.

[0109] Based on this, step 208: generating a target case report form corresponding to the form identification information based on the case report form template corresponding to the first maximum similarity value may specifically include:

[0110] A first setting instruction of a user for the case report form template corresponding to the first maximum similarity value is obtained; the first setting instruction is used to instruct to modify the form template information contained in the case report form template corresponding to the first maximum similarity value.

[0111] In response to the first setting instruction, the case report form template corresponding to the first similarity maximum value is modified to obtain a target case report form corresponding to the form identification information.

[0112] In an embodiment of the present specification, after determining the case report form template corresponding to the first maximum similarity value, the case report form template can be copied, thereby allowing the user to modify the copied case report form template while ensuring that the case report form template stored in the database remains unchanged, so as to obtain the target case report form corresponding to the form identification information.

[0113] In actual applications, the user may execute a single or multiple first setting instructions to add form information, modify or delete existing form information in the copied case report form template, and there is no specific limitation on this. Of course, if the user believes that there is no need to modify the case report form template corresponding to the first maximum similarity value, and it can be directly used as the target case report form corresponding to the form identification information, there is no need to execute the first setting instruction.

[0114] In the embodiments of this specification, after generating a target case report form, the user can also generate a new case report form template based on the target case report form, or update and maintain an existing case report form template. However, currently, it is usually necessary for professionals to check and verify each existing case report form template one by one, and update and maintain the case report form template by manual comparison and judgment, so that the accuracy of the update and maintenance of the case report form template is completely dependent on the operator's carefulness, and the management and maintenance process is inefficient.

[0115] Based on this, in the present exemplary embodiment, a variety of implementation methods for updating and maintaining the case report form template according to the target case report form generated in step 208 are also provided.

[0116] Implementation method 1

[0117] Step 208: After generating a target case report form corresponding to the form identification information based on the case report form template corresponding to the first maximum similarity value, the following may also be included:

[0118] A second similarity between each case report form template and the target case report form is determined.

[0119] A first page showing the second similarity corresponding to at least part of the case report form template is generated.

[0120] Obtain a second setting instruction input by the user based on the first page; the second setting instruction is used to instruct to modify the form template information contained in the first case report form template based on the form information contained in the target case report form, and the first case report form template belongs to the case report template corresponding to the second similarity displayed in the first page.

[0121] In response to the second setting instruction, the first case report form template is modified to obtain an updated first case report form template.

[0122] In an embodiment of the present specification, a user can view a target case report form generated for a clinical trial project. When the user performs a specified trigger operation on the target case report form, the terminal device can respond to the specified trigger operation to calculate the second similarity between each case report form template and the target case report form, and generate a first page showing a second similarity greater than a preset threshold and its corresponding case report form template, so that the user can update each case report form template displayed on the first page based on the target case report form.

[0123] The preset threshold can be set according to actual needs, for example, the preset threshold can be set to 30%. Then, only case report form templates with a similarity greater than 30% with the target case report form will be displayed on the first page, so that the user will only update and maintain the case report form templates with a similarity greater than 30% with the target case report form.

[0124] In practical applications, if there is a case report form template with a similarity of 100% with the target case report form, there is no need to modify the case report form template. If there is no case report form template with a similarity of more than 30% with the target case report form, the target case report form can be directly saved as a new case report form template. This can improve the efficiency of updating and managing case report form templates, and help reduce user misoperations, so as to improve the accuracy of updating and managing case report form templates.

[0125] In the embodiment of the present specification, the same principle as that for calculating the first similarity between the case report form template and the case report form to be generated in step 206 can be used to calculate the second similarity between each case report form template and the target case report form.

[0126] That is, determining the second similarity between each case report form template and the target case report form may specifically include:

[0127] For each case report form template, each information item contained in the case report form template is accurately matched and fuzzily matched with each information item contained in the target case report form to obtain an information item matching result including an information item accurate matching result and an information item fuzzy matching result.

[0128] According to the information item matching results corresponding to each information item in the case report form template, the matching degree corresponding to each information item in the case report form template is determined; the matching degree corresponding to any information item in the case report form template is used to reflect the matching degree between the any information item and the information item in the target case report form.

[0129] The product of the matching degree corresponding to each information item in the case report form template and the preset weight of the information type to which the information item belongs is calculated to obtain the weighted matching degree corresponding to each information item in the case report form template.

[0130] The average of the matched degrees corresponding to the information items in the case report form template, or the average of the weighted matched degrees corresponding to the information items in the case report form template, is determined as the second similarity between the case report form template and the target case report form.

[0131] Wherein, according to the information item matching results corresponding to each information item in the case report form template, determining the matching degree corresponding to each information item in the case report form template may specifically include:

[0132] If the information item corresponding to the information item in the case report form template has an exact match result indicating a successful match, then the matching degree corresponding to the information item is determined to be 100%.

[0133] If the fuzzy matching result of the information item corresponding to the information item in the case report form template indicates that the matching fails, it is determined that the matching degree corresponding to the information item is 0%.

[0134] If the exact matching result of the information items corresponding to some information items in the case report form template indicates a failed match, but the fuzzy matching result of the information items indicates a successful match, then for each information item in this part of the information items in the case report form template, the edit distance between the information item and the information item in the target case report form with which it is successfully fuzzily matched is calculated, and the maximum edit distance is determined; for each information item in this part of the information items in the case report form template, the difference between the maximum edit distance and the edit distance corresponding to the information item is calculated, and the quotient of the difference and the maximum edit distance is calculated to obtain the matching degree corresponding to the information item.

[0135] In practical applications, since the matching relationship and matching degree between the information items in the first case report form template and the target case report form are determined in the process of calculating the second similarity between the first case report form template and the target case report form, the matching relationship and matching degree between the information items in the first case report form template and the target case report form can also be displayed on the first page to facilitate the user to update the first case report form template based on the target case report form. In addition, controls for inputting the second setting command, such as "new control", "overwrite control" and "merge control", etc., are displayed on the first page.

[0136] For ease of understanding, Figure 3 This is a schematic diagram of a first page displayed in a terminal device provided in an embodiment of this specification. Figure 3As shown, the first page 31 displays various information items in the first case report form template, such as "tumor field", "high blood pressure", "cardiovascular and cerebrovascular diseases", "irregular snoring during sleep", "history of tumor surgery", etc.; the first page 31 also displays various information items in the target case report form, such as "tumor field", "hypertension", "heart", "sleep apnea hypopnea syndrome", "combined medication", etc.

[0137] Figure 3 There is a matching relationship between the information items in the first case report form template corresponding to the same information item serial number and the information items in the target case report form, and the degree of matching between the two is the matching degree corresponding to the information item serial number. At the same time, the user can update the first case report form template through the operation control corresponding to the information item serial number.

[0138] For example, if the user clicks on the "overlay control" 301 corresponding to information item number 2, the terminal device can obtain a second setting instruction for instructing to use the "hypertension" information to overwrite the "high blood pressure" information in the first case report form template, thereby modifying the "high blood pressure" in the first case report form template to "hypertension".

[0139] If the user clicks on the “Delete Control” 302 corresponding to information item number 4, the terminal device can obtain a second setting instruction for instructing to delete the “Irregular Sleep Snoring” information in the first case report form template, thereby deleting the “Irregular Sleep Snoring” information in the first case report form template.

[0140] If the user clicks on the "New Control" 303 corresponding to information item number 6, the terminal device can obtain the second setting instruction for instructing to add the "combined medication status" to the first case report form template, so that the "combined medication status" information can be added to the first case report form template.

[0141] In the embodiment of the specification, by displaying the matching relationship and matching degree between the first case report form template and the information items in the target case report form on the first page, and providing corresponding operation controls, the user can conveniently update the first case report form template based on the target case report form according to actual needs, which is conducive to improving the efficiency of updating and maintaining the case report form template. And because the terminal device can automatically complete the creation, overwriting and deletion of information items after the user clicks the operation control, it is no longer necessary to manually check or operate one by one, thereby reducing the error rate when updating and maintaining the case report form template, so as to improve the accuracy of updating and maintaining.

[0142] In practical applications, multiple information items in the first case report form template and the target case report form may also form multiple record information. For example, assuming that the three information items of red blood cell count, white blood cell count, and platelet count contained in the first case report form template constitute the multiple record information of the blood routine test result; and the five information items of red blood cell count, white blood cell count, platelet count, hemoglobin determination, and hemoglobin determination in the target case report form constitute the multiple record information of the blood routine test result, then when calculating the matching degree between the information items in the first case report form template and the target case report form, in addition to using the method mentioned in the above embodiment, the proportion of the number of the same fields contained in the two multiple record information that are fuzzy matched successfully in the first case report form template and the target case report form (i.e., 3 / 5) can also be used as the matching degree between the two multiple record information (i.e., 60%). This method is conducive to improving the efficiency of calculating the second similarity between the case report form template and the target case report form, and is also conducive to improving the accuracy of the calculated second similarity.

[0143] At the same time, on the first page, the matching relationship and matching degree between the first case report form template and the multiple record information in the target case report form can also be displayed, and operation controls corresponding to the multiple record information can be set to allow users to create, overwrite and delete multiple information items contained in the multiple record information through a single operation of the operation control, which is conducive to improving the update and maintenance efficiency.

[0144] Implementation method 2

[0145] Step 208: After generating a target case report form corresponding to the form identification information based on the case report form template corresponding to the first maximum similarity value, the following may also be included:

[0146] A third setting instruction of the user for the second case report form template is obtained; the third setting instruction is used to instruct to determine a third similarity between the second case report form template and the target case report form.

[0147] In response to the third setting instruction, a second page showing a third similarity between the second case report form template and the target case report form is generated.

[0148] A fourth setting instruction input by the user based on the second page is obtained; the fourth setting instruction is used to instruct to modify the form template information included in the second case report form template based on the form information included in the target case report form.

[0149] In response to the fourth setting instruction, the second case report form template is modified to obtain an updated second case report form template.

[0150] In an embodiment of the present specification, when the user has predetermined that the case report form template to be updated is the second case report form template, the user can directly input a third setting instruction for the second case report form template, and the terminal device can respond to the third setting instruction to calculate the third similarity between the second case report form template and the target case report form, and generate a second page showing the third similarity, so that the user can update the second case report form template based on the second page.

[0151] In the embodiment of the present specification, the same principle as that for calculating the first similarity between the case report form template and the case report form to be generated in step 206 can be used to calculate the third similarity between the second case report form template and the target case report form.

[0152] That is, generating a second page showing the third similarity between the second case report form template and the target case report form may specifically include:

[0153] Each information item included in the second case report form template is accurately matched and fuzzily matched with each information item included in the target case report form to obtain an information item matching result including an information item accurate matching result and an information item fuzzy matching result.

[0154] According to the information item matching results corresponding to each information item in the second case report form template, the matching degree corresponding to each information item in the second case report form template is determined; the matching degree corresponding to any information item in the second case report form template is used to reflect the degree of matching between the any information item and the information item in the target case report form.

[0155] The product of the matching degree corresponding to each information item in the second case report form template and the preset weight of the information type to which the information item belongs is calculated to obtain the weighted matching degree corresponding to each information item in the second case report form template.

[0156] The average of the matched degrees corresponding to the information items in the second case report form template, or the average of the weighted matched degrees corresponding to the information items in the second case report form template, is determined as the second similarity between the second case report form template and the target case report form.

[0157] Wherein, according to the information item matching results corresponding to the information items in the second case report form template, determining the matching degree corresponding to each information item in the second case report form template may specifically include:

[0158] If the exact match result of the information item corresponding to the information item in the second case report form template indicates a successful match, then it is determined that the matching degree corresponding to the information item is 100%.

[0159] If the fuzzy matching result of the information item corresponding to the information item in the second case report form template indicates that the matching fails, it is determined that the matching degree corresponding to the information item is 0%.

[0160] If the exact matching result of the information items corresponding to some information items in the second case report form template indicates a failed match, but the fuzzy matching result of the information items indicates a successful match, then for each information item in this part of the information items in the second case report form template, the edit distance between the information item and the information item in the target case report form with which it is fuzzily matched successfully is calculated, and the maximum edit distance is determined; for each information item in this part of the information items in the second case report form template, the difference between the maximum edit distance and the edit distance corresponding to the information item is calculated, and the quotient of the difference and the maximum edit distance is calculated to obtain the matching degree corresponding to the information item.

[0161] Of course, if the second case report form template and the target case report form have multiple record information that are fuzzy matched successfully, the proportion of the number of identical fields contained in the multiple record information that are fuzzy matched successfully between the second case report form template and the target case report form can be used as the matching degree between the multiple record information, which is convenient and quick.

[0162] In practical applications, since the matching relationship and matching degree between the information items and multi-record information in the second case report form template and the target case report form are determined in the process of calculating the third similarity between the second case report form template and the target case report form, in order to facilitate the user to update the second case report form template based on the target case report form, the matching relationship and matching degree corresponding to the information items, multi-record information, etc. in the second case report form template and the target case report form can also be displayed on the second page. And, controls for inputting the fourth setting command, such as "new control", "overwrite control" and "merge control", etc., are displayed on the second page. Since the information type and control type contained in the second page and the first page can be the same, the principle of the user inputting the fourth setting command based on the second page and the principle of the user inputting the second setting command based on the first page can also be the same, which will not be repeated.

[0163] In the embodiments of the present specification, by displaying the difference information between the target case report form and the case report form template on the first page and the second page, the operator does not need to check one by one to identify the difference information, which is beneficial to improving the accuracy and efficiency of updating and maintaining the case report form template; and because the user can control the terminal device to automatically complete the creation, overwriting and deletion of information items in the case report form template by triggering the operation controls in the first page and the second page, there is no need for manual checking and operation one by one, which is beneficial to further improving the accuracy and efficiency of updating and maintaining the case report form template.

[0164] Based on the same idea, the embodiments of this specification also provide a device corresponding to the above method. Figure 4 The embodiments of this specification provide corresponding to Figure 2 A schematic diagram of the structure of a case report form management device. Figure 4 As shown, the device may include:

[0165] The first acquisition module 402 is used to acquire project information of the clinical trial project.

[0166] The second acquisition module 404 is used to acquire the form identification information of the case report form to be generated in the clinical trial project.

[0167] The first determination module 406 is used to determine the first similarity between each case report form template and the case report form to be generated according to the project information and the form identification information.

[0168] The first generating module 408 is configured to generate a target case report form corresponding to the form identification information based on the case report form template corresponding to the first maximum similarity value.

[0169] based on Figure 4 The present specification also provides some specific implementation schemes of the device, which are described below.

[0170] Optionally, the first determining module 406 may include:

[0171] The first acquisition unit is used to acquire, for each case report form template, form template information included in the case report form template.

[0172] A matching unit is used to match each information item contained in the case report form information to be generated with each information item contained in the form template information to obtain an information item matching result; the case report form information to be generated includes the project information and the form identification information.

[0173] The first determination unit is used to determine the matching degree corresponding to each information item in the case report form information to be generated according to the information item matching results corresponding to each information item in the case report form information to be generated; the matching degree corresponding to any information item in the case report form information to be generated is used to reflect the matching degree between any one information item and the information item in the form template information.

[0174] The second determining unit is used to determine the first similarity between the case report form information to be generated and the form template information according to the matching degree corresponding to each information item in the case report form information to be generated.

[0175] Optionally, the matching unit may include:

[0176] The precise matching subunit is used to precisely match each information item contained in the case report form information to be generated with each information item contained in the form template information to obtain a precise matching result of the information items.

[0177] The first determining unit may include:

[0178] The first determination subunit is used to determine each first information item in the case report form information to be generated according to the accurate matching result of the information item; the accurate matching result corresponding to the first information item indicates a successful match; and determine that the matching degree corresponding to each first information item is 100%.

[0179] Optionally, the matching unit may further include:

[0180] The fuzzy matching subunit is used to perform fuzzy matching on each second information item in the case report form information to be generated with the information item in the form template information to obtain the information item fuzzy matching result; the information item exact matching result corresponding to the second information item indicates a matching failure.

[0181] The first determining unit may further include:

[0182] The second determination subunit is used to determine each third information item in the case report form information to be generated according to the fuzzy matching result of the information item; the fuzzy matching result of the information item corresponding to the third information item indicates a matching failure; and determine that the matching degree corresponding to each third information item is 0%.

[0183] Optionally, the first determining unit may further include:

[0184] The third determination subunit is used to determine each fourth information item in the case report form information to be generated according to the fuzzy matching result of the information item; the fuzzy matching result of the information item corresponding to the fourth information item indicates a successful match, and the fuzzy matching result of the information item corresponding to the fourth information item is also used to indicate the target information item in the form template information that is successfully fuzzy matched with the fourth information item.

[0185] For each of the fourth information items, an edit distance between the fourth information item and the target information item is calculated.

[0186] A maximum edit distance value is determined from the edit distances corresponding to the fourth information items.

[0187] For each of the fourth information items, a difference between the maximum edit distance and the edit distance corresponding to the fourth information item is calculated, and a quotient of the difference and the maximum edit distance is calculated to obtain a matching degree corresponding to the fourth information item.

[0188] Optionally, the second determining unit may be specifically configured to:

[0189] For any information item in the case report form information to be generated, the product of the matching degree corresponding to the any information item and the preset weight of the information type to which the any information item belongs is calculated to obtain the weighted matching degree corresponding to the any information item.

[0190] The sum of the weighted matching degrees corresponding to each information item in the case report form information to be generated is calculated to obtain a first similarity between the case report form information to be generated and the form template information.

[0191] Optionally, the first generating module may further include:

[0192] The second acquisition unit is used to obtain a first setting instruction from a user for the case report form template corresponding to the first similarity maximum value; the first setting instruction is used to instruct to modify the form template information contained in the case report form template corresponding to the first similarity maximum value.

[0193] A modification unit is used to modify the case report form template corresponding to the first similarity maximum value in response to the first setting instruction to obtain a target case report form corresponding to the form identification information.

[0194] Optional, Figure 4 The device may also include:

[0195] The second determination module is used to determine the second similarity between each case report form template and the target case report form.

[0196] The first page generating module is used to generate a first page showing the second similarity corresponding to at least part of the case report form template.

[0197] A third acquisition module is used to obtain a second setting instruction input by the user based on the first page; the second setting instruction is used to instruct to modify the form template information contained in the first case report form template based on the form information contained in the target case report form, and the first case report form template belongs to the case report template corresponding to the second similarity displayed in the first page.

[0198] The first updating module is used to modify the first case report form template in response to the second setting instruction to obtain an updated first case report form template.

[0199] Optional, Figure 4 The device may also include:

[0200] The fourth acquisition module is used to obtain a third setting instruction of the user for the second case report form template; the third setting instruction is used to instruct to determine a third similarity between the second case report form template and the target case report form.

[0201] The second page generating module is used to generate a second page showing a third similarity between the second case report form template and the target case report form in response to the third setting instruction.

[0202] A fifth acquisition module is used to acquire a fourth setting instruction input by the user based on the second page; the fourth setting instruction is used to instruct to modify the form template information included in the second case report form template based on the form information included in the target case report form.

[0203] The second updating module is used to modify the second case report form template in response to the fourth setting instruction to obtain an updated second case report form template.

[0204] Based on the same idea, the embodiments of this specification also provide a device corresponding to the above method.

[0205] Figure 5 The embodiments of this specification provide corresponding to Figure 2 A schematic diagram of the structure of a case report form management device. Figure 5 As shown, the device 500 may include:

[0206] at least one processor 510; and,

[0207] A memory 530 in communication with the at least one processor; wherein,

[0208] The memory 530 stores instructions 520 executable by the at least one processor 510. The instructions are executed by the at least one processor 510 to enable the at least one processor 510 to:

[0209] Get project information for clinical trial projects.

[0210] Obtain form identification information of a case report form to be generated in the clinical trial project.

[0211] According to the project information and the form identification information, a first similarity between each case report form template and the case report form to be generated is determined.

[0212] Based on the case report form template corresponding to the first maximum similarity value, a target case report form corresponding to the form identification information is generated.

[0213] Each embodiment in this specification is described in a progressive manner. The same or similar parts between the embodiments can be referred to each other. Each embodiment focuses on the differences from other embodiments. Figure 5 As for the device shown, since it is basically similar to the method embodiment, the description is relatively simple, and the relevant parts can be referred to the partial description of the method embodiment.

[0214] In the 1990s, improvements to a technology could be clearly distinguished as hardware improvements (for example, improvements to the circuit structure of diodes, transistors, switches, etc.) or software improvements (improvements to the method flow). However, with the development of technology, many improvements to the method flow today can be regarded as direct improvements to the hardware circuit structure. Designers almost always obtain the corresponding hardware circuit structure by programming the improved method flow into the hardware circuit. Therefore, it cannot be said that an improvement in a method flow cannot be implemented using a hardware entity module. For example, a programmable logic device (PLD) (such as a field programmable gate array (FPGA)) is such an integrated circuit whose logical function is determined by the user's programming of the device. Designers can "integrate" a digital system on a PLD by programming it themselves, without having to ask a chip manufacturer to design and produce a dedicated integrated circuit chip. Moreover, nowadays, instead of manually making integrated circuit chips, this kind of programming is mostly implemented by "logic compiler" software, which is similar to the software compiler used when developing and writing programs, and the original code before compilation must also be written in a specific programming language, which is called hardware description language (HDL). There is not only one HDL, but many kinds, such as ABEL (Advanced Boolean Expression Language), AHDL (Altera Hardware Description Language), Confluence, CUPL (Cornell University Programming Language), HDCal, JHDL (Java Hardware Description Language), Lava, Lola, MyHDL, PALASM, RHDL (Ruby Hardware Description Language), etc. The most commonly used ones are VHDL (Very-High-Speed ​​Integrated Circuit Hardware Description Language) and Verilog. Those skilled in the art should also know that it is only necessary to program the method flow slightly in the above-mentioned hardware description languages ​​and program it into the integrated circuit, and then it is easy to obtain the hardware circuit that implements the logic method flow.

[0215] The controller can be implemented in any appropriate manner, for example, the controller can take the form of a microprocessor or processor and a computer-readable medium storing a computer-readable program code (such as software or firmware) that can be executed by the (micro)processor, a logic gate, a switch, an application-specific integrated circuit (ASIC), a programmable logic controller, and an embedded microcontroller. Examples of controllers include, but are not limited to, the following microcontrollers: ARC 625D, Atmel AT91SAM, Microchip PIC18F26K20, and Silicone Labs C8051F320. The memory controller can also be implemented as part of the control logic of the memory. Those skilled in the art also know that in addition to implementing the controller in a purely computer-readable program code manner, the controller can be implemented in the form of a logic gate, a switch, an application-specific integrated circuit, a programmable logic controller, and an embedded microcontroller by logically programming the method steps. Therefore, this controller can be considered as a hardware component, and the devices included therein for implementing various functions can also be regarded as structures within the hardware component. Or even, the devices for implementing various functions can be regarded as both software modules for implementing the method and structures within the hardware component.

[0216] The systems, devices, modules or units described in the above embodiments may be implemented by computer chips or entities, or by products with certain functions. A typical implementation device is a computer. Specifically, the computer may be, for example, a personal computer, a laptop computer, a cellular phone, a camera phone, a smart phone, a personal digital assistant, a media player, a navigation device, an email device, a game console, a tablet computer, a wearable device, or a combination of any of these devices.

[0217] For the convenience of description, the above device is described in various units according to their functions. Of course, when implementing the present application, the functions of each unit can be implemented in the same or multiple software and / or hardware.

[0218] Those skilled in the art will appreciate that embodiments of the present invention may be provided as methods, systems, or computer program products. Therefore, the present invention may take the form of a complete hardware embodiment, a complete software embodiment, or an embodiment combining software and hardware. Moreover, the present invention may take the form of a computer program product implemented on one or more computer-usable storage media (including but not limited to disk storage, CD-ROM, optical storage, etc.) containing computer-usable program code.

[0219] The present invention is described with reference to flowcharts and / or block diagrams of methods, devices (systems), and computer program products according to embodiments of the present invention. It should be understood that each process and / or block in the flowchart and / or block diagram, as well as the combination of processes and / or blocks in the flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, an embedded processor, or other programmable data processing device to produce a machine, so that the instructions executed by the processor of the computer or other programmable data processing device generate instructions for implementing the processes in the flowchart and / or block diagram. Figure 1 A process or multiple processes and / or boxes Figure 1 A device that provides the functions specified in a block or multiple blocks.

[0220] These computer program instructions may also be stored in a computer-readable memory capable of directing a computer or other programmable data processing device to operate in a specific manner, so that the instructions stored in the computer-readable memory produce an article of manufacture comprising an instruction device, which implements the process Figure 1 A process or multiple processes and / or boxes Figure 1 A function specified in one or more boxes.

[0221] These computer program instructions can also be loaded onto a computer or other programmable data processing device so that a series of operating steps are executed on the computer or other programmable device to produce a computer-implemented process, thereby providing instructions for implementing the process. Figure 1 A process or multiple processes and / or boxes Figure 1 The steps for the functions specified in one or more boxes.

[0222] In a typical configuration, a computing device includes one or more processors (CPU), input / output interfaces, network interfaces, and memory.

[0223] The memory may include non-permanent storage in a computer-readable medium, random access memory (RAM) and / or non-volatile memory in the form of read-only memory (ROM) or flash RAM. The memory is an example of a computer-readable medium.

[0224] Computer readable media include permanent and non-permanent, removable and non-removable media that can be implemented by any method or technology to store information. Information can be computer readable instructions, data structures, program modules or other data. Examples of computer storage media include, but are not limited to, phase change memory (PRAM), static random access memory (SRAM), dynamic random access memory (DRAM), other types of random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory or other memory technology, compact disk read-only memory (CD-ROM), digital versatile disk (DVD) or other optical storage, magnetic cassettes, magnetic disk storage or other magnetic storage devices or any other non-transmission media that can be used to store information that can be accessed by a computing device. As defined herein, computer readable media does not include temporary computer readable media (transitory media), such as modulated data signals and carrier waves.

[0225] It should also be noted that the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, commodity or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, commodity or device. In the absence of more restrictions, the elements defined by the sentence "comprises a ..." do not exclude the existence of other identical elements in the process, method, commodity or device including the elements.

[0226] Those skilled in the art will appreciate that the embodiments of the present application may be provided as methods, systems or computer program products. Therefore, the present application may adopt the form of a complete hardware embodiment, a complete software embodiment or an embodiment in combination with software and hardware. Moreover, the present application may adopt the form of a computer program product implemented on one or more computer-usable storage media (including but not limited to disk storage, CD-ROM, optical storage, etc.) that contain computer-usable program code.

[0227] The present application may be described in the general context of computer-executable instructions executed by a computer, such as program modules. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform specific tasks or implement specific abstract data types. The present application may also be practiced in distributed computing environments where tasks are performed by remote processing devices connected through a communication network. In a distributed computing environment, program modules may be located in local and remote computer storage media, including storage devices.

[0228] The above is only an embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various changes and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the scope of the claims of the present application.

Claims

1. A case report form management method, characterized in that: include: Obtain project information of clinical trial projects; Obtaining form identification information of a case report form to be generated in the clinical trial project; Determining a first similarity between each case report form template and the case report form to be generated according to the project information and the form identification information; Based on the case report form template corresponding to the first similarity maximum value, generating a target case report form corresponding to the form identification information; Wherein, after generating a target case report form corresponding to the form identification information based on the case report form template corresponding to the first similarity maximum value, the method further includes: Determining a second similarity between each case report form template and the target case report form; generating a first page showing the second similarity corresponding to at least part of the case report form template; Acquire a second setting instruction input by the user based on the first page; The second setting instruction is used to instruct to modify the form template information included in the first case report form template based on the form information included in the target case report form, and the first case report form template belongs to the case report template corresponding to the second similarity displayed on the first page; In response to the second setting instruction, the first case report form template is modified to obtain an updated first case report form template.

2. The method according to claim 1, characterized in that Determining the first similarity between each case report form template and the case report form to be generated according to the project information and the form identification information specifically includes: For each case report form template, obtaining form template information contained in the case report form template; A first similarity between the form template information and the case report form information to be generated is calculated; the case report form information to be generated includes the project information and the form identification information.

3. The method according to claim 2, characterized in that The calculating the first similarity between the form template information and the case report form information to be generated specifically includes: Matching each information item contained in the case report form information to be generated with each information item contained in the form template information to obtain an information item matching result; Determine the matching degree corresponding to each information item in the case report form information to be generated according to the information item matching result corresponding to each information item in the case report form information to be generated; The matching degree corresponding to any one of the information items in the case report form information to be generated is used to reflect the matching degree between the any one of the information items and the information items in the form template information; According to the matching degree corresponding to each information item in the case report form information to be generated, a first similarity between the case report form information to be generated and the form template information is determined.

4. The method according to claim 3, characterized in that The step of matching each information item contained in the case report form information to be generated with each information item contained in the form template information to obtain an information item matching result specifically includes: Accurately matching each information item contained in the case report form information to be generated with each information item contained in the form template information to obtain an accurate matching result of the information items; The determining, according to the information item matching result corresponding to each information item in the case report form information to be generated, the matching degree corresponding to each information item in the case report form information to be generated specifically includes: According to the accurate matching result of the information item, determining each first information item in the case report form information to be generated; the accurate matching result corresponding to the first information item indicates a successful match; It is determined that the matching degree corresponding to each of the first information items is 100%.

5. The method according to claim 4, characterized in that The step of matching each information item contained in the case report form information to be generated with each information item contained in the form template information to obtain an information item matching result further includes: Performing fuzzy matching on each second information item in the case report form information to be generated and the information item in the form template information to obtain a fuzzy matching result of the information item; an exact matching result of the information item corresponding to the second information item indicates a matching failure; The step of determining the matching degree corresponding to each information item in the case report form information to be generated according to the information item matching result corresponding to each information item in the case report form information to be generated further includes: According to the fuzzy matching result of the information item, determining each third information item in the case report form information to be generated; the fuzzy matching result of the information item corresponding to the third information item indicates that the matching fails; It is determined that the matching degree corresponding to each of the third information items is 0%.

6. The method according to claim 5, characterized in that The step of determining the matching degree corresponding to each information item in the case report form information to be generated according to the information item matching result corresponding to each information item in the case report form information to be generated further includes: Determine each fourth information item in the case report form information to be generated according to the fuzzy matching result of the information item; The fuzzy matching result of the information item corresponding to the fourth information item indicates a successful match, and the fuzzy matching result of the information item corresponding to the fourth information item is also used to indicate a target information item in the form template information that successfully fuzzily matches the fourth information item; For each of the fourth information items, calculating an edit distance between the fourth information item and the target information item; Determine a maximum edit distance from the edit distances corresponding to the fourth information items; for each fourth information item, calculate a difference between the maximum edit distance and the edit distance corresponding to the fourth information item, and calculate a quotient of the difference and the maximum edit distance to obtain a matching degree corresponding to the fourth information item.

7. The method according to claim 3, characterized in that The determining, according to the matching degree corresponding to each information item in the case report form information to be generated, the first similarity between the case report form information to be generated and the form template information specifically includes: For any information item in the case report form information to be generated, calculate the product of the matching degree corresponding to the any information item and the preset weight of the information type to which the any information item belongs, and obtain the weighted matching degree corresponding to the any information item; The sum of the weighted matching degrees corresponding to each information item in the case report form information to be generated is calculated to obtain a first similarity between the case report form information to be generated and the form template information.

8. The method according to claim 1, characterized in that The step of generating a target case report form corresponding to the form identification information based on the case report form template corresponding to the first similarity maximum value specifically includes: Obtaining a first setting instruction from a user for the case report form template corresponding to the first maximum similarity value; the first setting instruction is used to instruct to modify form template information included in the case report form template corresponding to the first maximum similarity value; In response to the first setting instruction, the case report form template corresponding to the first maximum similarity value is modified to obtain a target case report form corresponding to the form identification information.

9. The method according to claim 1, characterized in that After generating a target case report form corresponding to the form identification information based on the case report form template corresponding to the first similarity maximum value, the method further includes: Obtaining a third setting instruction from a user for a second case report form template; the third setting instruction is used to instruct determination of a third similarity between the second case report form template and the target case report form; In response to the third setting instruction, generating a second page showing a third similarity between the second case report form template and the target case report form; Acquire a fourth setting instruction input by the user based on the second page; the fourth setting instruction is used to instruct to modify the form template information included in the second case report form template based on the form information included in the target case report form; In response to the fourth setting instruction, the second case report form template is modified to obtain an updated second case report form template.

10. A case report form management device, characterized in that: include: The first acquisition module is used to obtain project information of clinical trial projects; A second acquisition module is used to acquire form identification information of a case report form to be generated in the clinical trial project; A first determination module, configured to determine a first similarity between each case report form template and the case report form to be generated according to the project information and the form identification information; A first generating module, configured to generate a target case report form corresponding to the form identification information based on the case report form template corresponding to the first similarity maximum value; Wherein, the device further comprises: A second determination module, used to determine a second similarity between each case report form template and the target case report form; A first page generating module, used for generating a first page showing the second similarity corresponding to at least part of the case report form template; A third acquisition module is used to acquire a second setting instruction input by the user based on the first page; the second setting instruction is used to instruct to modify the form template information included in the first case report form template based on the form information included in the target case report form, and the first case report form template belongs to the case report template corresponding to the second similarity displayed on the first page; The first updating module is used to modify the first case report form template in response to the second setting instruction to obtain an updated first case report form template.

11. The device according to claim 10, characterized in that The first determination module includes: a first acquisition unit, configured to acquire, for each case report form template, form template information included in the case report form template; A matching unit, used for matching each information item contained in the case report form information to be generated with each information item contained in the form template information to obtain an information item matching result; the case report form information to be generated includes the project information and the form identification information; A first determining unit is used to determine the matching degree corresponding to each information item in the case report form information to be generated according to the information item matching result corresponding to each information item in the case report form information to be generated; the matching degree corresponding to any one information item in the case report form information to be generated is used to reflect the matching degree between the any one information item and the information item in the form template information; The second determining unit is used to determine the first similarity between the case report form information to be generated and the form template information according to the matching degree corresponding to each information item in the case report form information to be generated.

12. The device according to claim 11, characterized in that The matching unit comprises: An accurate matching subunit, used for accurately matching each information item contained in the case report form information to be generated with each information item contained in the form template information to obtain an accurate matching result of the information items; The first determination unit includes: a first determination subunit, used to determine each first information item in the case report form information to be generated according to the accurate matching result of the information item; the accurate matching result corresponding to the first information item indicates a successful match; and determine that the matching degree corresponding to each first information item is 100%.

13. The device according to claim 12, characterized in that The matching unit further includes: A fuzzy matching subunit is used to perform fuzzy matching on each second information item in the case report form information to be generated and the information item in the form template information to obtain a fuzzy matching result of the information item; an exact matching result of the information item corresponding to the second information item indicates a matching failure; The first determination unit also includes: a second determination subunit, which is used to determine each third information item in the case report form information to be generated according to the fuzzy matching result of the information item; the fuzzy matching result of the information item corresponding to the third information item indicates a matching failure; and determine that the matching degree corresponding to each third information item is 0%.

14. The device according to claim 13, characterized in that The first determining unit further includes: A third determination subunit is used to determine each fourth information item in the case report form information to be generated according to the fuzzy matching result of the information item; the fuzzy matching result of the information item corresponding to the fourth information item indicates a successful match, and the fuzzy matching result of the information item corresponding to the fourth information item is also used to indicate a target information item in the form template information that successfully fuzzily matches the fourth information item; for each of the fourth information items, the edit distance between the fourth information item and the target information item is calculated; from the edit distances corresponding to each of the fourth information items, a maximum edit distance value is determined; for each of the fourth information items, a difference between the maximum edit distance value and the edit distance corresponding to the fourth information item is calculated, and a quotient of the difference and the maximum edit distance value is calculated to obtain a matching degree corresponding to the fourth information item.

15. The device according to claim 10, characterized in that The first generating module comprises: A second acquisition unit is used to acquire a first setting instruction of a user for the case report form template corresponding to the first similarity maximum value; the first setting instruction is used to instruct to modify the form template information included in the case report form template corresponding to the first similarity maximum value; A modification unit is used to modify the case report form template corresponding to the first similarity maximum value in response to the first setting instruction to obtain a target case report form corresponding to the form identification information.

16. The device according to claim 10, characterized in that The device also includes: A fourth acquisition module, used to acquire a third setting instruction of the user for the second case report form template; the third setting instruction is used to instruct to determine a third similarity between the second case report form template and the target case report form; A second page generating module, configured to generate, in response to the third setting instruction, a second page showing a third similarity between the second case report form template and the target case report form; a fifth acquisition module, configured to acquire a fourth setting instruction input by a user based on the second page; the fourth setting instruction is configured to instruct to modify the form template information included in the second case report form template based on the form information included in the target case report form; The second updating module is used to modify the second case report form template in response to the fourth setting instruction to obtain an updated second case report form template.

17. A case report form management device, characterized in that: include: at least one processor; and a memory connected to the at least one processor in communication; wherein the memory stores instructions executable by the at least one processor, the instructions being executed by the at least one processor so that the at least one processor can: obtain project information of a clinical trial project; obtain form identification information of a case report form to be generated in the clinical trial project; determine a first similarity between each case report form template and the case report form to be generated based on the project information and the form identification information; generate a target case report form corresponding to the form identification information based on the case report form template corresponding to the first similarity maximum value; determine a second similarity between each case report form template and the target case report form; generate a first page displaying the second similarity corresponding to at least part of the case report form template; obtain a second setting instruction input by a user based on the first page; the second setting instruction is used to instruct to modify the form template information contained in the first case report form template based on the form information contained in the target case report form, the first case report form template belonging to the case report template corresponding to the second similarity displayed in the first page; in response to the second setting instruction, modify the first case report form template to obtain an updated first case report form template.

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