JP2004038594A - System, device, method, and program for managing clinical trial database - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a clinical trial database management system for normally leaving a correction history when data is changed, and also to provide its device, its method, and its program. <P>SOLUTION: The system manages a clinical trial database 6 including a plurality of tables 4 for registering information concerning a clinical trial. The system includes: a change prohibiting means for prohibiting data change in the table 4 with respect to a data change instruction without a change right; a means for displaying a screen 62 comprising a change instruction means 625 to instruct data change; and a change permitting means for imparting the change right to the instruction when the data change instruction is issued from the change instruction means 625. <P>COPYRIGHT: (C)2004,JPO

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a clinical trial database management system, a clinical trial database management device, a clinical trial database management method, and a clinical trial database management program, and in particular, a clinical trial database management system, a clinical trial database management device, and a clinical trial database that can always leave a revision history when data is changed. The present invention relates to a management method and a trial database management program.
[0002]
[Prior art]
In the process of new drug development, we conduct basic research to select compounds with high potential from new drug candidates, and then conduct non-clinical tests to examine pharmacological effects using animals. After that, a clinical trial is conducted, and the results of the clinical trial are submitted to the Ministry of Health, Labor and Welfare for approval review. When production is approved, a new drug can be launched.
In clinical trials, in response to a request from a pharmaceutical company that developed a new drug, a medical institution administers the new drug to healthy adults or patients with a disease to which the new drug is applied, and submits the results of the clinical trial to the Ministry of Health, Labor and Welfare. After approval is received and production is approved, a new drug can be launched.
[0003]
GCP (Good Clinical Practice) is defined for the purpose of ensuring the scientific quality of clinical trials and the reliability of results. The GCP stipulates that a revision history must be left when modifying clinical trial data.
As a clinical trial management system for registering and managing clinical trial data in order to satisfy the requirements of the GCP, there is known a technology for constructing a clinical trial database provided with a history table for storing a correction history.
In a clinical trial management system equipped with such a history table, trial data such as test result data is input / corrected on the data registration / correction screen, and during the input / correction operation, the trial data before correction is manually or automatically changed. It is configured to leave in the history table.
[0004]
However, in this conventional clinical trial management system, when data is corrected via the data registration / correction screen, the trial data before correction is stored in the history table. When the data is corrected, the data before the correction is not stored.
[0005]
[Problems to be solved by the invention]
An object of the present invention is to solve the above-mentioned problems, and to provide a trial database management system, a trial database management device, a trial database management method, and a trial database management program capable of always leaving a revision history when data is changed. It is in.
Another object of the present invention is to provide a clinical trial database management system and a clinical trial database that can prevent a trial database from being changed by means other than a predetermined method and can more reliably store a correction history when data is changed. A management device, a trial database management method, and a trial database management program are provided.
[0006]
[Means for Solving the Problems]
According to the first aspect of the present invention, there is provided a system for managing a clinical trial database including a plurality of tables for registering information relating to a clinical trial, wherein a data change command without a change authority is not stored in the table. A means for displaying a screen (update screen 62) including a change prohibiting means (trigger) for prohibiting change, a change instruction means (execute button 625) for instructing data change, and a data change instruction issued by the change instruction means. In such a case, the above problem is solved by providing a change permission unit for giving the change authority to the instruction.
[0007]
According to the fourth aspect of the present invention, there is provided an apparatus for managing a clinical trial database including a plurality of tables for registering information on clinical trials, the data being stored in the table in response to a data change command having no change authority. Means for displaying a screen including change prohibition means for prohibiting change, change instruction means for instructing data change, and a change for granting the change authority to the instruction when a data change instruction is issued by the change instruction means And permission means.
[0008]
According to the seventh aspect of the present invention, there is provided a method for managing a clinical trial database including a plurality of tables for registering information on clinical trials, wherein a screen including a change instruction unit for instructing data change is displayed. Procedure, when a data change command is issued by the change command means, an authorization granting procedure for granting the change authority to the command, and when a data change command is issued, only when accompanied by the change authority, And a permission procedure for permitting data change of the table.
[0009]
According to the tenth aspect of the present invention, there is provided a device for managing a clinical trial database including a plurality of tables for registering information relating to a clinical trial, including a procedure for displaying a screen including change instruction means for instructing data change. An authorization granting procedure for granting the change authority to the data change instruction when the data change instruction is issued by the change instruction means; and And a permission procedure for permitting a data change of the trial database management program.
[0010]
As described above, in response to a data change command without a change authority, a change prohibiting unit that prohibits data change of the table, a unit that displays a screen including a change command unit that commands data change, By providing a change permitting means for giving the change authority to the command when a change command is issued, it is possible to permit the change of the trial database only when accessed from a predetermined screen. Therefore, if a predetermined function, such as forcibly leaving a correction history, is added to the screen including the change instruction means, it is possible to always execute the predetermined function when data is changed. Further, it is possible to prevent the trial database from being changed by directly using the INSERT statement, the UPDATE statement, and the DELETE statement without using the screen including the change instruction means.
[0011]
At this time, it is preferable that the change permission unit is configured to copy information registered in the table in which the data change instruction has been issued, to a history table for storing a history of the table.
In this way, for a data change command without change authority, data change of the table is prohibited, and information registered in the table in which the data change command is issued is stored in a history table for storing the history of the table. Since the data is copied, it is possible to satisfy the GCP's requirement that a revision history is always left when data in the clinical trial database is changed.
[0012]
At this time, it is preferable that the change authority be deleted after the data change is completed.
With this configuration, it is possible to grant change authority for each session to the trial database, prohibit data changes in the trial database by means other than predetermined, and forcibly save the revision history when data is changed Can be executed more reliably.
[0013]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, an embodiment of the present invention will be described with reference to the drawings. The configuration and the like described below do not limit the present invention and can be variously modified within the scope of the present invention.
The clinical trial database management system according to the present embodiment is a system for storing, when a change is made in the clinical trial database 6 of the clinical trial management system for managing test result data of a clinical trial, a correction history of all the changes.
[0014]
The clinical trial management system is provided with a clinical trial database 6 for storing data such as test results generated in clinical trials, and for supporting creation of a clinical trial case report requested by a pharmaceutical company or the like developing a drug. Used for
The clinical trial management system is constructed by a case report support company, and is controlled by a server computer (not shown) installed in the case report support company.
The case report support company is an organization that supports the preparation of case reports for clinical trials. The case registration company is structured as an independent organization different from pharmaceutical companies and medical institutions.
[0015]
FIG. 1 shows a process of creating the clinical trial database management system of the present embodiment.
In the present embodiment, the program of the template development tool 3 executes the program processing of the template 2 for the plurality of table-structured documents 1 to generate the plurality of tables 4 and the history table 5. At this time, a trigger is set in the table 4 and the history table 5 to prohibit data change without change authority. In this way, a clinical trial database management system is created. The generated table 4 and history table 5 constitute the clinical trial database 6.
[0016]
The clinical trial of the present embodiment is requested by a pharmaceutical company that develops a new drug to a medical institution, and is performed at the medical institution.
Pharmaceutical companies are organizations that develop new drugs, and ask medical institutions for clinical trials of the new drugs they have developed. When the clinical trial database management system according to the present embodiment is a test for confirming the effects of foods and cosmetics, a food company, a cosmetics manufacturer, and the like are used instead of a pharmaceutical company.
[0017]
When a medical institution is requested to conduct a clinical trial, the medical institution is responsible for conducting the clinical trial to the extent requested. The medical institution gives informed consent to the test candidate who intends to participate in the clinical trial, and when consent is obtained, conducts a medical interview, a medical examination, a background survey, and the like.
[0018]
In addition, samples such as blood and urine collected at a medical institution are sent to an inspection center, where a clinical test is performed.
The results of the interviews, consultations, background investigations, etc., and the results of the clinical tests are transmitted to the case report support company and registered in the clinical trial database 6 of the clinical trial management system.
[0019]
In the clinical trial database management system according to the present embodiment, the database management for the clinical trial of the new drug, but bioequivalence test of the generic drug, bioavailability test, post-marketing investigation of the drug, health food, What kind of test database should be constructed if it is a test that administers substances to humans continuously for a certain period of time, such as a test to confirm the effects of specified health foods, functional foods, cosmetics, etc. May be used.
The clinical trial of a new drug may be any of the first to third phases, and may be any of a clinical pharmacology test, an exploratory test, a confirmatory test, and a therapeutic test.
[0020]
In this specification, “computer” is meant to include all information terminals provided with a computing device. For example, in addition to a supercomputer, a general-purpose computer, an office computer, a control computer, a workstation, and a personal computer, a mobile information terminal, a mobile phone equipped with an arithmetic device, and the like are also included.
[0021]
Next, a server computer (not shown) installed in the case report support company will be described.
A server computer (not shown) is a computer that controls the clinical trial database management system and the clinical trial management system of the present embodiment, and the clinical trial database 6 is registered therein.
[0022]
FIG. 2 shows the hardware configuration of the server computer.
The server computer includes a CPU 72 as a data calculation / control processing device (central processing unit), a RAM 73, a ROM 74, an HDD 75, and a storage medium device 76 as storage devices. Further, a communication device 77, a keyboard 78, a mouse 79, a display device 80, and a printer 81 are provided.
[0023]
The CPU 72 performs a calculation using information received from the storage device or the input device, and serves to pass a result of the calculation to the storage device or the output device. According to a program stored in the ROM 74 or the HDD 75, the CPU 72 performs various operations. Execute the process.
[0024]
The storage device stores programs and the like for executing various processes. Among the storage devices, the storage medium device 76 is configured by an external HDD, a media device such as an MO, a CD-RW, and a DVD, and is transmitted from the data transmitted via the communication device 77, the keyboard 78 and the mouse 79. Various kinds of input data can be appropriately stored and read out.
[0025]
The RAM 73 stores data and the like necessary for the CPU 72 to execute various types of processing. The keyboard 78 and the mouse 79 are appropriately operated when various commands are input to the CPU 72.
[0026]
The display device 80 is a device that displays an image or the like created by the CPU 72 according to a program stored in the ROM 74, the HDD 75, or the like. The printer 81 outputs predetermined information from each computer on paper.
The communication device 77 transmits data to the Internet or another computer, and receives data from the Internet or another computer.
[0027]
The HDD 75 stores the table structure document 1, template 2, and template development tool 3 of FIG. After the trial database 6 including the table 4 and the history table 5 is created, the trial database 6 is also stored in the HDD 75.
[0028]
An example of the table structure document 1 is shown in FIG.
FIG. 3 is a table structure document 1 of an inspection result table for registering inspection results.
Here, the table-structured document 1 refers to a document on which the table 4 is based, and a field name 11, a data type 12, a data length 13, and the like corresponding to fields other than the history management field 411 of the table 4 are registered. .
An empty field 111 is provided in the table structure document 1, and the history management field 411 of the table 4 can be formed in the empty field 111.
[0029]
The table structure document 1 is created for each table 4 included in the trial database 6. For example, as the table structure document 1 for the master table of the clinical trial database 6, a trial master table structure document having fields such as a trial name and a test drug name, and fields such as a subject number, a physician's name, and the date of obtaining consent are provided. Subject master table structure document, medical institution master table structure document with fields such as medical institution name and planned number of subjects, test item master table structure document with fields such as test item name, input range check range, trial code, Many table structure documents 1 such as a time master table structure document having a field such as a time point name are registered.
[0030]
The template 2 is a program for generating a table 4 and a history table 5 based on the table structure document 1. The processing executed by the template 2 will be described later with reference to FIG.
The template development tool 3 is a program that reads the table structure document 1 and the template 2 and issues an instruction to the template 2 to generate the table 4 and the history table 5. The processing executed by the template development tool 3 will be described later with reference to FIG.
[0031]
The table 4 is a table generated from the table structure document 1 and the template 2, and is a table for registering information acquired during the clinical trial.
An example of the table 4 is shown in FIG. FIG. 4 is an inspection result table for registering inspection results.
In Table 4, a field name 41, a data type 42, and a data size 43 of each field are defined.
The table 4 has a vertically stacked arrangement in which the fields are arranged in the vertical direction. Each record is stacked up and down, and the next record is registered below the previous record. In the example of FIG. 4, a second record 422 is registered below the first record 421.
[0032]
Each data area includes a history management field 411, a key field 412, and a content field 413.
In the history management field 411, as shown in FIG. 4, a record number which is a serial number specifying the record in the table 4, an update type indicating whether the correction is insertion, update, or deletion, a reason for the correction. , The confirmation level 1 (contents) and its updater name / update date, and the confirmation level 2 (contents) and its updater name / update date are included.
[0033]
When an insert / update / delete command is issued for the record of the table 4, the value of the history management field 411 is compared with the value of the corresponding history management field of the history table (not shown), and the table 4 is updated. It is possible to determine whether the history of the data is copied to the history table.
The key field 412 is a field in which a primary key is stored. In the example of FIG. 4, a trial code for referring to a trial project name, a sponsor name, and the like in a trial master table, and a medical institution name in a medical institution master table -Includes fields such as medical institution codes for referring to medical institution contact information.
[0034]
The content field 413 is a field in which data on test results such as test result data, subject interview results, and test dates are stored.
As shown in FIG. 4, the content field 413 includes a preset field 416, a class code field 414, and a free field 415.
The preset field 416 is a field in which items to be input are specifically defined in advance. In the example of FIG. 4, items such as an inspection date, a reception date, a unit, a comment, and the like, in which data is predetermined, correspond to the items.
[0035]
The free field 415 is a field in which items to be input are not specifically defined in advance. The items input to the free field 415 are specifically defined in the class code definition table 44 of FIG. 5 which refers to the class code as a key.
The class code definition table 44 in FIG. 5 refers to the class code field 441 and the field name 442, data type 443, size 444, and option code definition table 45 in FIG. 6 that define the free field 415 in FIG. The option code 445 is included.
By the class code field 441, the field name 442, the data type 443, the size 444, and the option code 445, all items of the free field 415 in FIG. 4 are specifically defined.
[0036]
In addition to the class definition table 44, the option code definition table 45 of FIG.
The option code table 45 in FIG. 6 is a table that is referred to from the table 4, the class definition table 44, and the like using the option code 445 as a key, and is a table that defines specific contents of each option.
[0037]
The option code table 45 includes an option code 451, an option value field 452, a data type 453, and a size 454 that define the values of options registered in the table 4, the class definition table 44, and the like.
[0038]
In the example of FIG. 5, the field of the result character 1 of FIG. 4 is defined as a character string option type field “whether or not consent is obtained” of size 3 by the fields 442 to 444 of FIG.
When the option code 445 is referred to in the option code definition table 45 of FIG. 6, since the data at the time of the option “1” is “Yes”, the field of the result character 1 of FIG. Yes ".
[0039]
The history table 5 is a table in which data before correction of the table 4 in FIG. 4 is registered. The configuration of the fields of the history table 5 is the same as that of the table 4 except that a history record number field is included between the record number field and the update type field.
The history record number is a number for uniquely specifying each record in the history table 5, and is separately provided from the record number for uniquely specifying each record in the table 4.
[0040]
The trial database 6 includes a table 4 and a history table 5.
The trial database 6 is generated by combining the table structure document 1 with the template 2 by the template development tool 3, as shown in FIG.
[0041]
Next, a procedure for creating the trial database 6 and a procedure for using the trial database 6 will be described with reference to FIG.
The case report support company creates a clinical trial management system in order to provide case report support services for a plurality of trials.
In the creation of the clinical trial management system, first, in process 101, a table structure document 1, a template 2, and a template development tool 3 are created. The table structure document 1 is a set of document sheets shown in FIG. The document sheets are created by the number of tables 4 necessary for managing the clinical trial information.
[0042]
Next, in a process 102, the table structure document 1 and the template 2 are designated, and the table structure document 1 is developed by the template developing tool 3.
In this process, a table 4 in which a history management field 411 is connected to the table structure document 1 and a history table 5 in which a history management field for a history table (not shown) is connected to the table structure document 1 are created.
Further, a trigger is set in the table 4 and the history table 5 to prohibit the table 4 and the history table 5 from being modified without authority.
In this process 102, all the tables 4 and the history table 5 are generated, and the clinical trial database 6 capable of managing a plurality of clinical trial information is constructed.
[0043]
When the construction of the clinical trial database 6 is completed, the case report support company can receive an order for a case report support service using the clinical trial database 6 from a pharmaceutical company.
When a pharmaceutical company requests support for preparing a case report for a clinical trial, the case report supporting company inputs initial information of the clinical trial to the clinical trial database 6 as a process 103 in a preparation stage of the clinical trial.
[0044]
Specifically, the information of the trial, for example, the trial, is stored in each master table such as the trial master table, the medical institution master table, the subject master table, the subject master table, the examination item master table, the time point master table, and the user master table in the trial database 6. The trial project number to be identified, trial name, identification number of the sponsoring pharmaceutical company, pharmaceutical company name, pharmaceutical company monitor identification number, monitor name, monitor access authority, monitor contact information, medical institution identification number, Register the name of the medical institution, the investigator's name, the access authority of the investigator, the subject identification number, the subject's initials, attributes such as the subject's gender and date of birth, test items, test time, and other information.
[0045]
By registering the initial information of the trial, the trial database 6 can input, browse, and manage test results of the trial.
Next, after the start of the clinical trial and during the progress of the clinical trial, in step 104, the case report support company registers and corrects test result data and the like.
When the clinical trial is completed, a case report or the like can be created using the test result data and the like in the clinical trial database 6 registered and corrected in the process 104 and accumulated.
[0046]
When requested to provide a case report support service for another trial, the case report support company performs the processing 103 and the processing 104 for the next trial.
Each time the case report support service is requested for a clinical trial, the processing 103 and the processing 104 are repeated, and the case report support service for a plurality of clinical trials is performed using the single clinical trial database 6.
The above is the processing of the block diagram of FIG.
[0047]
Next, details of the clinical trial database 6 creation processing of the present embodiment shown in the block diagrams of FIGS. 1 and 7 will be described.
First, the details of the process 102 in FIG. 7 will be described with reference to the flowcharts in FIGS.
At the case report support company, a system technician in charge of building the clinical trial database 6 first creates the table structure document 1, the template 2, and the template development tool 3 to generate the clinical trial database 6 (the processing in FIG. 7). 101).
[0048]
Next, on a screen of a terminal computer (not shown) connected to the server computer, clicking an icon (not shown) of the template development tool 3 displays a template development screen 31 of FIG.
On the template development screen 31, a document selection button 312 for selecting a file of the table structure document 1 from the HDD 75 of the server computer, a document display field 311 for displaying a file name of the selected table structure document 1, a template A template selection button 314 for selecting from the HDD 75 of the server computer, a template display field 313 for displaying the selected template name, and an execution button 315 for starting template development are displayed.
[0049]
When a document selection button 312 is clicked on the template development screen 31, a list of files in the server computer is displayed. When the file of the table structure document 1 is selected from this list, the file name of the table structure document 1 is displayed in the document display column 311. Similarly, when a template selection button 314 is clicked, a list of files in the server computer is displayed. When a template 2 is selected from this list, a file name of the template 2 is displayed in a template display field 313.
[0050]
When the template development screen 31 of FIG. 8 is displayed, the flowchart of the template development tool of FIG. 9 starts. The flowchart of FIG. 9 is controlled by the CPU 72 of the server computer.
First, in step S101, it is determined whether the execution button 315 has been clicked.
If the execution button 315 has not been clicked (step S101: NO), the system administrator determines that the user does not intend to create the clinical trial database 6, and ends the processing.
[0051]
When the execute button 315 is clicked (step S101: YES), the template 2 displayed in the template display field 313 is read in step S102.
Next, in step S103, it is determined whether reading of the template 2 has failed.
[0052]
If the reading of the template 2 has failed (step S103: YES), it is determined that the template 2 has not been selected, an error screen indicating that the path name is invalid is displayed in step S104, and an execution button is pressed in step S101. It is determined whether 315 has been clicked.
[0053]
If the reading of the template 2 has not failed (step S103: NO), it is determined that the template 2 has been properly selected and the template can be expanded, and a file for storing the trial database 6 is created in step S105. . Next, in step S106, one sheet of the document is read from the file of the table structure document 1, and in step S107, the template 2 is started by designating this sheet. As a result, the template 2 is activated, and the processing of the program shown in FIG. 10 is executed.
[0054]
Next, in step S108, it is determined whether the processing of the program of the template 2 is completed.
If the processing of the template 2 program has not been completed (step S108: NO), it is again determined in step S108 whether the processing of the template 2 program has been completed. That is, step S108 is repeated until the processing of the program of template 2 is completed.
[0055]
If the processing of the program of the template 2 is completed (step S108: YES), it is determined in step S109 whether the file of the table structure document 1 has a sheet of the next document.
If there is a sheet of the next document (step S109: YES), the sheet of the next document is read in step S110, and the template 2 is started by designating this sheet in step S107.
If there is no sheet for the next document (step S109: NO), it is assumed that the processing of the program of the template 2 in FIG. 10 has been completed for all sheets, and the processing ends.
[0056]
Next, the details of the processing of the template 2 in the processing 102 of FIG. 7 will be described based on the flowchart of FIG. The processing in FIG. 10 is controlled by the CPU 72 of the server computer.
When the template 2 is activated in step S107 of the flowchart of FIG. 9, the flowchart of FIG. 10 starts.
[0057]
First, in step S201, a table 4 corresponding to the sheet read in step S106 or step S110 in FIG. 9 is created.
Next, in step S202, a history management field 411 is generated in the table 4.
In step S203, a key field is obtained from the sheet of the table structure document 1, and a key field 412 is added below the history management field 411 of the table 4.
[0058]
Next, in step S204, a content field is acquired from the sheet of the table structure document 1, and a content field 413 is added below the key field 412 of the table 4.
In step S205, the history table 5 corresponding to the sheet read in step S106 in FIG. 9 is created.
[0059]
Next, in step S206, a history management field (not shown) is generated in the history table 5. The history management field (not shown) is similar to the history management field 411 except that a history record number is included below the record number.
In step S207, a key field is acquired from the sheet of the table structure document 1, and a key field similar to the key field 412 is added below the history management field of the history table 5.
[0060]
Next, in step S208, a content field is acquired from the sheet of the table structure document 1, and a content field similar to the content field 413 is added below the key field of the history table 5.
[0061]
In step S209, a trigger is set in the table 4 created in steps S201 to S204 to prohibit the table 4 from being modified without storing the modification history in the history table 5. Here, other triggers such as a trigger for automatically registering the record number, update date, and update type (insertion) in the history management field 411 when a record is inserted may be set.
[0062]
Next, in step S210, a trigger is set in the history table 5 created in steps S205 to S208 to prohibit modification of the history table 5 without authority. Other triggers may be set, such as a trigger for automatically registering the record number, update date, and update type (insertion) in a history management field (not shown) when a record is inserted.
After that, the process ends.
[0063]
By the steps S201 to S210 in FIG. 10, the table 4 and the history table 5 corresponding to the sheet of the table structure document 1 read in the step S106 in FIG. 9 are completed.
When the processing in FIG. 10 ends, “YES” is determined in the step S108 in FIG. 9, and the processing in the step S109 is performed.
[0064]
9 and 10, the table 4 and the history table 5 are created for all the sheets of the table structure document 1 included in the file of the table structure document 1. The set of the table 4 and the history table 5 constitutes the clinical trial database 6, and the clinical trial database 6 is completed by the processing of FIGS.
[0065]
When the trial database 6 is completed, the case report support company inputs initial information of the requested trial into the trial database 6 (process 103 in FIG. 7).
After the start of the clinical trial, the test result data generated during the clinical trial is registered in the clinical trial database 6, and the data is updated or deleted as needed (processing 104 in FIG. 7).
The processing executed when the person in charge of the case report support company corrects the information in the clinical trial database 6 will be described with reference to the flowcharts of FIGS.
[0066]
When a person in charge of the case report support company connects to the server computer from the terminal computer and clicks an icon (not shown) of the clinical trial management system on the screen of the terminal computer, a main menu screen (not shown) of the clinical trial management system is displayed.
On the main menu screen, a trial selection box for selecting a trial to work on, a user information button for browsing user information of a trial management system user, a trial button for displaying a trial result screen (not shown), a subject, A subject button for displaying information, a CSV output button for outputting data stored in the trial database 6 in CSV format, a file list search button for searching a file list, and a close button for closing a main menu screen. Buttons and the like are displayed.
[0067]
When a clinical trial is selected in the clinical trial selection box on the main menu screen and the clinical trial button is clicked, a clinical trial result screen (not shown) is displayed.
On the trial result screen (not shown), the trial name selected on the main menu screen (not shown) is displayed, a test result button for displaying the test result screen 61 in FIG. The illustrated button, a button (not shown) for displaying the subject schedule, a button (not shown) for displaying the self-objective symptom screen, and the like are displayed.
[0068]
When a test result button is clicked on a test result screen (not shown), a test result screen 61 in FIG. 11 is displayed.
The test result screen 61 in FIG. 11 is a screen that displays the test results registered in the clinical trial database 6 and can be switched to a test result registration screen, an update screen 62, and a delete screen.
[0069]
On the inspection result screen 61, a selection box 611 for specifying data to be extracted, a search button 612 for extracting the data specified in the selection box 611, and a data for displaying the data extracted by clicking the search button 612 are displayed. A data display field 613, a registration button 614 for displaying a registration screen (not shown) for inputting inspection result data, a correction button 615 for displaying the update screen 62 of FIG. A deletion screen 616 for displaying a deletion screen (not shown) to be deleted, a close button 617 for closing the inspection result screen 61, and an inspection date etc. input field 618 are displayed.
[0070]
When the operator inputs an inspection date, an inspection time, a worksheet number, and the like in the inspection date etc. input field 618 and clicks a correction button 614 on the inspection result screen 61, an update screen 62 in FIG. 12 is displayed. FIG. 12 shows data extracted under the conditions entered in the input column 618 for the examination date and the like.
[0071]
On the update screen 62, an extraction condition display column 621 displaying the extraction conditions of the data displayed on the update screen 62, a data display column 622 displaying the extracted data, and an execute button 625 for executing the correction are displayed. You.
In the data display column 622, a check column 623 for selecting data to be corrected and a detail display button 624 for shifting to the detail display screen 63 are displayed for each data.
[0072]
When the check box 623 of the data to be corrected is checked and the detail display button 624 is clicked, a detail display screen 63 shown in FIG. 13 is displayed.
In the detailed display screen 63, an extraction condition display column 631 for displaying data information in detail, a correction column 632 for inputting correction contents of data, a reason column 633 for inputting a correction reason, and the input correction contents are temporarily registered. Input button 634 for returning to update screen 62 in FIG. 12 is displayed.
[0073]
When the content of the correction is input in the correction column 632, the correction reason is input in the reason column, and the input button 634 is clicked, the screen returns to the update screen 62 of FIG.
At this time, the contents input on the detailed display screen 63 of FIG. 13 are registered in the update screen 62.
[0074]
When the update screen 62 of FIG. 12 is displayed, the flowchart of FIG. 14 starts. The flowchart of FIG. 14 is controlled by the CPU 72 of the server computer.
First, in step S301, it is determined whether the execution button 625 has been clicked. If the execute button 625 has not been clicked (step S301: NO), it is determined that the person in charge has no intention to make a correction, and the process ends.
[0075]
If the execution button 625 is clicked (step S301: YES), in step S302, a record for the session in the table 4 specified in the extraction condition display column 621 of FIG. Determine if there is.
Registered as items in the session authority table are a session ID for specifying a session, a table name for the session, and an authority level for setting the presence or absence of authority.
[0076]
The session ID is set for each session, and even when accessing the same table 4, if the session is different, another ID is assigned.
When the authority level is greater than 0, it is determined that the authority level exists.
[0077]
If the session authority table includes a record for the session in the table 4 (step S302: YES), the authority level of the record for the session in the table 4 is incremented by one in step S303. By this processing, the authority level becomes 1.
Next, in step S305, the record to be corrected in the table 4 is sent to the history table 5.
[0078]
If there is no record in the session authority table for the session in the table 4 (step S302: NO), in step S304, a record with the authority level = 1 for the session in the table 4 is stored in the session authority table. Generate.
Next, in step S305, the record to be corrected in the table 4 is sent to the history table 5.
[0079]
In step S306, an update check program is started. This update check program is a program that executes the processing of the flowchart shown in FIG. 15, and starts up in step S306 to execute the processing of FIG.
Next, in step S307, it is determined whether write permission has been issued by the processing of the update check program. In step S307, it is determined whether the write permission in step S403 of FIG. 15 has been granted.
[0080]
If write permission has not been issued (step S307: NO), it is determined in step S310 whether an error display in step S404 has been made in the processing of the update check program in FIG.
When the error display of FIG. 15 is displayed (step S310: YES), it is determined that the update should not be permitted by the update check program, and the process ends.
In the processing of the flowchart of FIG. 14, since the authority level is a positive value in steps S303 and S304, it is extremely rare that YES is determined in step S310.
[0081]
If the error display in FIG. 15 is not displayed (step S310: NO), it is determined that the processing in FIG. 15 by the update check program has not been completed, and in step S307, it is determined whether the write permission has been issued by the processing in the update check program. I do.
If write permission is given (step S307: YES), the data is rewritten in step S308 to the correction contents instructed when the execution button is clicked in step S301.
[0082]
Next, in step S309, the authority level of the session authority table is decremented by one, and the process ends.
As in steps S303, S304, and S309 of the flowchart of FIG. 14, the session authority can be granted for each session by raising and lowering the authority level of the session authority table. , It is possible to prohibit the modification of the record of the table 4.
[0083]
Next, the processing of the flowchart in FIG. 15 will be described.
The processing of the flowchart in FIG. 15 is automatically executed by the trigger set in the table 4 in step S209. The processing of the flowchart in FIG. 15 is controlled by the CPU 72 of the server computer.
[0084]
When a correction command including update, insertion, and deletion is issued to the table 4, the flowchart of FIG. 15 starts.
When an update, insert, or delete command is issued, a registration screen (not shown) displayed by clicking a registration button 614, a correction button 615, or a deletion button 616 in FIG. 11, an update screen 62 in FIG. In addition to the case where the execution button is clicked on the deletion screen, the case where the modification is instructed directly to the table 4 using the INSERT statement, the UPDATE statement, and the DELETE statement is also included.
[0085]
First, in step S401, it is determined whether there is a record in the session authority table for the session in the table 4. In this step, a session authority table (not shown) is referred to using the table 4 name and the session ID of the session as keys, and it is determined whether there is a record to be hit.
[0086]
If there is no record in the session authority table (step S401: NO), an unillustrated message in step S404, stating, "This session does not have the authority to modify the clinical trial database. Please modify according to the correct procedure" Display an error screen. At the same time, this session is regarded as unauthorized access, and the user ID, the access time, and the contents of the commanded correction are registered in a memory (not shown).
[0087]
If there is a record in the session authority table (step S401: YES), it is determined in step S402 whether the authority level of the session in the table 4 is greater than 0.
If the authority level of the session is greater than 0 in the table 4 (step S402: YES), in step S403, a command is issued to permit the update, insertion, and deletion of the correction contents to be instructed, and the process ends.
[0088]
If the authorization level of the session in the table 4 is not> 0 (step S402: NO), that is, if the authorization level of the session is 0 or less, in step S404, "the trial database is modified for this session. You do not have the authority. Please correct it according to the correct procedure. " At the same time, this session is regarded as unauthorized access, and the user ID, the access time, and the contents of the commanded correction are registered in a memory (not shown).
After that, the process ends.
[0089]
【The invention's effect】
As described above, according to the present invention, for a data change command without change authority, a change prohibition unit that prohibits data change of the table, and a unit that displays a screen including a change command unit that commands data change, When a data change instruction is issued by the change instruction means, by providing a change permission means for giving the change authority to the instruction, the change of the clinical trial database is permitted only when accessed from a predetermined screen. Becomes possible. Therefore, if a predetermined function, such as forcibly leaving a correction history, is added to the screen including the change instruction means, it is possible to always execute the predetermined function when data is changed. Further, it is possible to prevent the trial database from being changed by directly using the INSERT statement, the UPDATE statement, and the DELETE statement without using the screen including the change instruction means.
[Brief description of the drawings]
FIG. 1 is an explanatory diagram showing an outline of a trial database creation procedure.
FIG. 2 is an explanatory diagram showing a hardware configuration of a server computer of the clinical trial database management system according to one embodiment of the present invention.
FIG. 3 is an explanatory diagram showing an example of a table structure document configuration.
FIG. 4 is an explanatory diagram showing an example of a table configuration.
FIG. 5 is an explanatory diagram showing an example of a class code definition table.
FIG. 6 is an explanatory diagram showing an example of an option code definition table.
FIG. 7 is an explanatory diagram showing a procedure for creating and using a trial database.
FIG. 8 is an explanatory diagram showing a template development screen.
FIG. 9 is a flowchart illustrating processing of a template development tool.
FIG. 10 is a flowchart showing template processing.
FIG. 11 is an explanatory diagram showing an inspection result screen.
FIG. 12 is an explanatory diagram showing an update screen.
FIG. 13 is an explanatory diagram showing a detailed display screen.
FIG. 14 is a flowchart showing processing when an execution button on an update screen is clicked.
FIG. 15 is a flowchart illustrating processing of a trigger set in a table.
[Explanation of symbols]
1 Table structure document 2 Template 3 Template development tool 4 Table 5 History table 6 Clinical trial database 31 Template development screen 61 Inspection result screen 62 Update screen 63 Detailed display screen 72 CPU
73 RAM
74 ROM
75 HDD
76 storage medium device 77 communication device 78 keyboard 79 mouse 80 display device 81 printer

Claims (12)

A system for managing a clinical trial database including a plurality of tables for registering information regarding a clinical trial,
Change prohibition means for prohibiting data change of the table in response to a data change instruction not having a change right;
Means for displaying a screen including change command means for commanding data change;
A trial database management system, comprising: a change permitting unit that, when a data change command is issued by the change command unit, grants the change authority to the command. 2. The clinical trial database management system according to claim 1, wherein the change permitting unit copies information registered in the table to which the data change instruction has been issued, into a history table for storing a history of the table. 2. The clinical trial database management system according to claim 1, wherein the change authority is deleted after the data change is completed. An apparatus for managing a clinical trial database including a plurality of tables for registering information regarding a clinical trial,
Change prohibition means for prohibiting data change of the table in response to a data change instruction not having a change right;
Means for displaying a screen including change command means for commanding data change;
A trial database management device, comprising: a change permitting unit that, when a data change command is issued by the change command unit, gives the command the change authority. 5. The clinical trial database management device according to claim 4, wherein the change permitting unit copies information registered in the table to which the data change instruction has been issued, into a history table for storing a history of the table. 5. The clinical trial database management device according to claim 4, wherein the change authority is deleted after the data change is completed. A method of managing a clinical trial database having a plurality of tables for registering information regarding clinical trials,
Displaying a screen including change instruction means for instructing data change;
When a data change command is issued by the change command unit, an authorization granting procedure for granting the change authority to the command;
A method of managing a trial database, comprising: when a data change instruction is issued, performing a permission procedure for permitting data change of the table only when accompanied by the change authority. Between the authorization procedure and the permission procedure, the information registered in the table in which the data change instruction has been issued by the change instruction means is copied to a history table that stores the history of the table. The method for managing a clinical trial database according to claim 7. 8. The clinical trial database management method according to claim 7, wherein the change authority is deleted after the data change permitted in the permission procedure is completed. A device that manages a clinical trial database with multiple tables for registering information about clinical trials,
Displaying a screen including change instruction means for instructing data change;
When a data change command is issued by the change command unit, an authorization granting procedure for granting the change authority to the command;
A trial database management program for executing, when a data change instruction is issued, a permission procedure for permitting data change of the table only when accompanied by the change authority. Between the authorization procedure and the permission procedure, the information registered in the table for which the data change command has been issued by the change command means is copied to a history table for storing the history of the table. The clinical trial database management program according to claim 10, wherein: 11. The clinical trial database management program according to claim 10, wherein the change authority is deleted after completing the data change permitted in the permission procedure.

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