JP2015125514A - Clinical trial data administration device and clinical trial system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To reliably notify a determining doctor of emergency safety information or safety alerts in a clinical trial.SOLUTION: When receiving a reference request of image data from a determining doctor terminal used by a determining doctor who determines efficacy of an investigational new drug in a clinical trial (step T11; YES), and when emergency safety information or the like exists for a medicament used in the clinical trial (step T12; YES), it is determined whether an opening flag corresponding to the determining doctor is [0: unopened] or not with respect to an object clinical trial, on the basis of a safety information administration table. When the opening flag is [0] (step T13; YES), the determining doctor terminal is notified of the emergency safety information or the like (step T14). When an opening notification of the emergency safety information or the like is received from the determining doctor terminal (step T15; YES), the opening flag corresponding to the determining doctor is changed to [1: opened] (step T16), and the determining doctor terminal is provided with image data (step T18).

Description

  The present invention relates to a clinical trial data management apparatus and a clinical trial system.

  Conventionally, when a drug candidate is newly developed by a pharmaceutical company, a test for confirming the effect and safety as a drug for a plurality of patients is performed. Specifically, a pharmaceutical company requests clinical trials and clinical research including clinical trials and investigations using images (hereinafter referred to as “clinical trials” for convenience) to clinical trial institutions such as hospitals. The institution will give medication and treatment to patients (subjects) who will cooperate in the clinical trial. In the case of a clinical trial using medical images, the site to be studied is imaged by CT (Computed Tomography), CR (Computed Radiography), MRI (Magnetic Resonance Imaging), or the like. The captured image is determined by a plurality of doctors, and the pharmaceutical company confirms the utility and safety of the new drug based on the determination result, and makes a pharmaceutical application based on the result.

  For example, RECIST (Response Evaluation Criteria in Solid Tumors) determination is used for drug efficacy determination for solid cancer. A device has been proposed that calculates the longest diameter of the slice cross section of the target lesion specified in the image data obtained by imaging before the drug administration (baseline) and multiple times after drug administration, and calculates the RECIST determination result. (See Patent Document 1).

  In addition, in the clinical trial of pharmaceuticals, when a side effect due to the drug being used or a malfunction due to a combination of medications occurs, it is obliged to provide information to pharmaceutical personnel in order to prevent this. Such provision of information is classified into emergency safety information (yellow letter) and safety bulletin (blue letter) according to the degree of urgency. Mandatory.

JP 2010-35634 A

  However, in clinical trials involving image determination as described above, multiple safety doctors are requested to make image decisions for each clinical trial, so emergency safety information or safety bulletins are distributed directly to all doctors. It took a lot of work to do. Moreover, it is not possible to confirm whether or not the judging doctor has read the distributed document simply by distributing the emergency safety information or the safety bulletin.

  The present invention has been made in view of the above-described problems in the prior art, and it is an object of the present invention to reliably notify emergency physicians of emergency safety information or safety bulletins in clinical trials.

  In order to solve the above-mentioned problem, the invention described in claim 1 is connected to a judging doctor terminal used by a judging doctor who judges the effect of an investigational drug in a clinical trial so that data communication is possible via a network. A clinical trial data management device that manages image data obtained by imaging a target region of a patient and a determination result determined by the determination physician based on the image data in association with the clinical trial. The emergency safety information or safety bulletin for the drug used in the clinical trial and the unsealing information indicating whether or not the emergency safety information or safety bulletin is displayed on the judging medical terminal are stored in association with each other. And when the image data reference request is received from the judging medical terminal, based on the opening information stored in the storage means, the emergency safety information or It is determined whether or not an integrity warning is displayed on the determination medical terminal, and when it is determined that the emergency safety information or the safety warning is displayed on the determination medical terminal, the image data for which the reference request has been made Control means for providing to the determination medical terminal.

  The invention described in claim 2 is the clinical trial data management apparatus according to claim 1, wherein the control means determines that the emergency safety information or the safety preliminary report is not displayed on the determination medical terminal. The emergency safety information or the safety bulletin is provided to the determination medical terminal, and the emergency safety information or the safety bulletin is displayed on the determination medical terminal, and then the image data requested for the reference is determined in the determination Provide to the medical terminal.

  The invention described in claim 3 is connected to the clinical trial data management apparatus according to claim 1 or 2 so that data communication is possible via a network with a pharmaceutical company terminal installed in a pharmaceutical company that requests the clinical trial, When the control means receives emergency safety information or safety bulletin for the drug used in the clinical trial from the pharmaceutical company terminal, the control means corresponds to the received emergency safety information or safety bulletin with the clinical trial. In addition, it is stored in the storage means.

  The invention according to claim 4 includes a determination medical terminal used by a determination doctor who determines the effect of a study drug in a clinical trial, image data obtained by imaging a target region of a patient in the clinical trial, and the image data. And a clinical trial data management apparatus that manages the judgment results determined by the judgment physician in association with each other via a network so that data communication is possible, the clinical trial data management apparatus, For clinical trials, emergency safety information or safety bulletin for the drug used in the trial, and unsealing information indicating whether or not the emergency safety information or safety bulletin is displayed on the judgment medical terminal, Storage means for storing the information in association with each other, and when a reference request for image data is received from the judging medical terminal, based on the opening information stored in the storage means, When it is determined whether emergency safety information or safety bulletin is displayed on the determination medical terminal, and it is determined that the emergency safety information or safety bulletin is displayed on the determination medical terminal, the reference request is Control means for providing the determined image data to the determination medical terminal.

  ADVANTAGE OF THE INVENTION According to this invention, the emergency safety information in a clinical trial or a safety preliminary report can be reliably notified to the judgment doctor.

It is a system configuration figure of a clinical trial system in an embodiment of the invention. It is a block diagram which shows the functional structure of a clinical trial data management apparatus. It is a figure which shows the example of a part of trail DB. It is a figure which shows the example of a safety information management table. It is a block diagram which shows the functional structure of a clinical trial implementation medical institution terminal. It is a block diagram which shows the functional structure of a pharmaceutical company terminal. It is a block diagram which shows the functional structure of a determination medical terminal. It is a ladder chart which shows the outline | summary of the process performed by each apparatus of a clinical trial system. It is a ladder chart which shows the outline | summary of the process performed by each apparatus of a clinical trial system. It is a ladder chart which shows the outline | summary of the process performed by each apparatus of a clinical trial system. It is a flowchart which shows emergency safety information etc. registration processing performed in a clinical trial data management apparatus. It is a flowchart which shows the process at the time of determination performed in a clinical trial data management apparatus.

  Hereinafter, an embodiment of a clinical trial system according to the present invention will be described with reference to the drawings. However, the scope of the invention is not limited to the illustrated examples.

[Composition of clinical trial system]
FIG. 1 shows a system configuration of a clinical trial system 100 in the present embodiment.
As shown in FIG. 1, the clinical trial system 100 includes a clinical trial data management apparatus 10 installed in a clinical trial contracting organization, a clinical trial implementation medical institution terminal 20, a PACS 30 and a modality installed in a clinical trial implementation medical institution conducting a trial of a new drug. 40, a pharmaceutical company terminal 50 installed in the pharmaceutical company, and a plurality of judgment doctor terminals 60 used by a plurality of judgment doctors who judge the effect of the investigational drug. The “clinical trial” in this specification includes clinical trials and clinical research including clinical trials of new drugs, research using images, and the like for convenience of explanation. The clinical trial data management apparatus 10, the clinical trial institution terminal 20, the pharmaceutical company terminal 50, and the judgment medical terminal 60 are connected to be able to perform data communication via a communication network N1 such as the Internet. In FIG. 1, one clinical trial medical institution is illustrated, but actually there are a plurality of clinical trial medical institutions.

  The clinical trial data management apparatus 10 accumulates and manages information related to clinical trials requested by pharmaceutical companies. The clinical trial data management apparatus 10 transmits the clinical trial conditions to the clinical trial medical institution terminal 20 and receives image data obtained by photographing the target region of the patient before and after the medication from the clinical trial implementation medical institution terminal 20. The clinical trial data management apparatus 10 transmits an image data determination request to the determining doctor terminal 60 and receives the determination result determined by the determining doctor from the determining doctor terminal 60.

  The clinical trial medical institution terminal 20, the PACS 30, and the modality 40 are configured to be mutually communicable via an in-facility network N2 such as a LAN (Local Area Network).

  The clinical trial institution terminal 20 transmits the imaging conditions included in the clinical trial conditions received from the clinical trial data management apparatus 10 to the modality 40. The clinical trial institution terminal 20 transmits the image data of the medical image generated by the modality 40 to the clinical trial data management apparatus 10.

  The PACS 30 stores medical image image data and the like generated by the various modalities 40, and provides medical image image data and the like in response to a request from an external device.

  The modality 40 captures an image of the patient's determination target region based on the imaging conditions transmitted from the clinical trial medical institution terminal 20, and digitally converts the captured image to generate image data of a medical image. The modality 40 is configured by, for example, CT, CR, MRI, and the like. The modality 40 appends incidental information to the medical image by writing incidental information such as patient information and imaging information in the header of the image file of the medical image in accordance with the DICOM (Digital Imaging and Communications in Medicine) standard.

  The pharmaceutical company terminal 50 is a computer device used by a pharmaceutical company person requesting a clinical trial. The pharmaceutical company terminal 50 is used when requesting a clinical trial instruction or the like from the clinical trial data management apparatus 10 or confirming the progress of each clinical trial.

  The judging doctor terminal 60 receives the image data judgment request from the clinical trial data management apparatus 10 and transmits the judgment result to the clinical trial data management apparatus 10.

FIG. 2 shows a functional configuration of the clinical trial data management apparatus 10.
As shown in FIG. 2, the clinical trial data management apparatus 10 includes a control unit 11, an operation unit 12, a display unit 13, a communication unit 14, a ROM (Read Only Memory) 15, a RAM (Random Access Memory) 16, a storage unit 17, and the like. Each part is connected by a bus 18.

  The control unit 11 is composed of a CPU (Central Processing Unit) and the like, and comprehensively controls the processing operation of each unit of the clinical trial data management apparatus 10. Specifically, the CPU reads various processing programs stored in the ROM 15 in accordance with an operation signal input from the operation unit 12 or an instruction signal received by the communication unit 14, expands the program in the RAM 16, and executes the program. Various processes are performed in cooperation with

  The operation unit 12 includes a keyboard having cursor keys, numeric input keys, various function keys, and the like, and a pointing device such as a mouse. The control unit 11 receives operation signals input by keyboard operations or mouse operations. Output to.

  The display unit 13 includes a monitor such as an LCD (Liquid Crystal Display), and displays various screens according to instructions of a display signal input from the control unit 11.

  The communication unit 14 includes a network interface and the like, and transmits and receives data to and from an external device connected via the communication network N1.

  The ROM 15 is configured by a nonvolatile semiconductor memory or the like, and stores a control program, parameters and files necessary for executing the program, and the like. For example, the ROM 15 has a function as a Web server for providing various Web screens to the Web browser by communicating with the Web browser installed in the clinical trial medical institution terminal 20, the pharmaceutical company terminal 50, and the judging doctor terminal 60 using the HTTP protocol. A web server program for realizing the above, an application program that runs on the web server, and provides an online clinical trial service to the operator of each apparatus via a web browser are stored.

  The RAM 16 forms a work area that temporarily stores various programs, input or output data, parameters, and the like read from the ROM 15 in various processes that are executed and controlled by the control unit 11. For example, the RAM 16 temporarily stores image data received from the clinical trial medical institution terminal 20.

  The storage unit 17 is configured by an HDD (Hard Disk Drive), a semiconductor nonvolatile memory, or the like, and stores various data. For example, the storage unit 17 stores a trail DB (DataBase) 171, an image DB 172, a judgment doctor candidate correspondence table 173, and a safety information management table 174.

The trail DB 171 is a database for storing data related to the clinical trial for each clinical trial.
The trail DB 171 includes, for each clinical trial, a clinical trial requester, a clinical trial drug, a lesion name, case information, clinical trial conditions, clinical trial institution information, masking information, and the like.

The clinical trial requester is an organization requesting a clinical trial such as a pharmaceutical company.
The investigational drug is the drug that is the subject of the trial.
The lesion name is the name of the lesion to be treated in the clinical trial.
Case information is information relating to a case that is a target of a new drug.
The clinical trial conditions are information indicating the clinical trial conditions, and include dosage, timing of medication / imaging, imaging device information, imaging conditions (imaging site, imaging direction, slice thickness, etc.) and the like.
The clinical trial institution information is information on a medical facility (hospital) where the clinical trial is conducted.
The masking information includes items (patient name, birthday, etc.) to be masked in the image data used for the determination of the clinical trial. Normally, personal information such as patient information that can identify the patient is deleted from the incidental information of the image data, but for items determined to be relevant for each trial, such as patient age, height, and weight, Removed from deletion.

In addition, in the trail DB 171, for each trial, for each of a plurality of patients, information indicating image data obtained by imaging the target region of the patient at a plurality of timings, determination results determined by the determining doctor based on the image data, and the like Are stored in association with information indicating the timing at which the image data was captured.
In the clinical trial data management apparatus 10, personal information that can identify a patient is concealed, and a patient who is a subject is managed by a clinical trial ID. The clinical trial ID is identification information assigned to each subject in order to anonymize the subject in the clinical trial. The clinical trial ID used in the clinical trial is notified from the clinical trial data management apparatus 10 to the clinical trial medical institution terminal 20.

  FIG. 3 shows an example of a part of the trail DB 171. As shown in FIG. 3, in the trail DB 171, for each of a plurality of patients (trial IDs), an imaging date, imaging timing, a sender, a transmission date and time, the number of images, a QC (Quality Control) confirmation result, a file Paths and determination results are associated with each other.

The shooting date is the date when the image was shot.
The imaging timing is information indicating the timing at which image data was captured, such as before medication, first time after medication, second time after medication, third time after medication, and so on.
The sender is information (name, user ID, etc.) indicating the person who sent the image data from the trial medical institution terminal 20.
The transmission date and time is the date and time when the image data is transmitted from the clinical trial institution terminal 20.
The number of images is the number of image data transmitted from the clinical trial medical institution terminal 20.

The QC confirmation result is information indicating whether or not the image data is suitable for image determination. For example, “1” is stored when the image data is suitable for image determination, and “0” is stored when the image data is not suitable for image determination.
The file path is information indicating a storage location of image data in the image DB 172.

In the determination result, the determination result of each determination doctor is stored for each of the plurality of determination doctors. The determination result includes information indicating the effect and safety of the investigational drug determined from the image data, and includes, for example, information indicating the longest diameter (measurement data) of the target lesion in the image and the degree of the effect. When there are a plurality of target lesions in the image, numbers are assigned to the target lesions, and changes for each imaging are described as numerical values for each target lesion.
The image data and the determination result are associated with each other through the file path of the trail DB 171.

  Note that the image data is stored in the image DB 172 only when the image data is suitable for image determination. Therefore, when the image data is not suitable for image determination (when the QC confirmation result is “0”). The file path and determination result fields are blank. When image data is retransmitted from the clinical trial institution terminal 20, it is registered as another record in the trail DB 171. In other words, even with respect to image data that has not been used for image determination, there is a history that it is determined that the image data is not suitable for image determination as a result of when it was transmitted from the clinical trial medical institution terminal 20 and QC confirmation was performed. .

  The image DB 172 stores image data of a plurality of medical images.

  The judgment doctor candidate correspondence table 173 is a table in which a plurality of judgment doctor candidates and specialized fields (parts, lesions, interpretable cases, etc.) are associated with each other and registered in advance. Candidate doctor candidates are radiologists who are interested in determination, and only doctors who can agree to the rules in the clinical trial system 100 are registered. In addition, since the judging doctor candidate is required to understand the ministerial ordinance and duties unique to the clinical trial, it is preferable that education for the judging doctor candidate is carried out regularly.

  FIG. 4 shows an example of the safety information management table 174. In the safety information management table 174, for each clinical trial, the date and time when the emergency safety information or safety bulletin for the drug used in the trial was registered, and the storage location of the emergency safety information or safety bulletin data And an opening flag and an opening date and time are associated with each of a plurality of judging doctors. “Drugs used in clinical trials” include trial drugs and control drugs used in comparative studies.

The column of the judging doctor of the safety information management table 174 stores a user ID when the judging doctor logs in to the clinical trial system 100 (online clinical trial service provided by the clinical trial data management apparatus 10).
The unsealing flag is unsealing information indicating whether the emergency safety information or the safety preliminary report is displayed on the judging doctor terminal 60 corresponding to each judging doctor.
The opening date / time is the date / time when the emergency safety information or the safety preliminary report is displayed on the judgment doctor terminal 60 corresponding to each judgment doctor.

  Emergency safety information is in a situation where urgent and serious alerts or countermeasures related to use restrictions are required for the public or medical personnel in order to prevent the occurrence or spread of health hazards due to the use of pharmaceuticals, etc. It is issued by orders from the Ministry of Health, Labor and Welfare, instructions, voluntary decisions by manufacturers and distributors, etc. The emergency safety information is called a yellow letter because it is created on yellow paper.

  The safety bulletin is based on the emergency safety information, and it is necessary to alert the pharmaceutical personnel more promptly than the general information on revision of precautions, or to take appropriate measures for proper use. It is issued in case. Since the safety bulletin is made of blue paper, it is called a blue letter.

  The control unit 11 acquires image data obtained by imaging the target region of the patient at a plurality of timings in the clinical trial from the clinical trial medical institution terminal 20 via the communication network N1, and the acquired image data is captured by the image data. The information is stored in the storage unit 17 (the trail DB 171 and the image DB 172) in association with the information indicating the timing.

  The control unit 11 acquires the determination result determined by the determining doctor based on the image data stored in the storage unit 17 from the determining medical terminal 60 via the communication network N1, and uses the acquired determination result as the determination target. Are stored in the storage unit 17 (the trail DB 171 and the image DB 172) in association with the image data.

  When the control unit 11 receives emergency safety information or a safety bulletin for a drug used in a clinical trial from the pharmaceutical company terminal 50, the control unit 11 associates the received emergency safety information with the clinical trial related to the drug or The safety bulletin is stored in the storage unit 17. Specifically, the control unit 11 stores emergency safety information or safety safety bulletin for the drug used in the clinical trial in the storage unit 17 and is used for the clinical trial project and clinical trial in the safety information management table 174. The registration date and time of emergency safety information or safety bulletin, and emergency safety information or safety bulletin file path are stored in association with each other (study drug or control drug). In addition, a plurality of decision physicians (user IDs) are stored in association with the clinical trial project, and the opening flag corresponding to each decision physician (determination physician terminal 60) is set to “0” in the initial state.

  When the control unit 11 receives a reference request for image data from the judging medical terminal 60, the control unit 11 refers to the safety information management table 174, and emergency safety information or safety bulletin corresponds to the clinical trial related to the image data. Determine whether it is attached.

  When the emergency safety information or the safety bulletin is associated with the clinical trial, the control unit 11 refers to the safety information management table 174 and refers to the corresponding determining doctor (determining medical terminal 60 in the corresponding clinical trial). Whether or not the emergency safety information or the safety preliminary report is displayed on the determining medical terminal 60 is determined based on the unsealing flag corresponding to the determining doctor who is logged in. Specifically, when the opening flag is “1”, it is determined that the emergency safety information or the safety bulletin is displayed on the determination medical terminal 60, and when the opening flag is “0” It is determined that the safety information or the safety bulletin is not displayed on the determination medical terminal 60.

  When it is determined that the emergency safety information or the safety bulletin is displayed on the determination medical terminal 60, that is, when the opening flag is “1”, the control unit 11 determines the image data requested for reference to the determination medical doctor. Provided to the terminal 60.

  When it is determined that the emergency safety information or the safety bulletin is not displayed on the determination medical terminal 60, that is, when the opening flag is “0”, the control unit 11 performs the emergency safety information or the safety bulletin. Is provided to the judging doctor terminal 60. For example, the control unit 11 notifies the judgment medical terminal 60 that there is emergency safety information or safety bulletin that should be opened for the relevant clinical trial, and the operation from the operation unit 62 of the judgment medical terminal 60 In response to an operation for opening the emergency safety information or safety bulletin file, display data for displaying the emergency safety information or safety bulletin is provided to the judgment medical terminal 60. When the emergency safety information or the safety bulletin is displayed on the judging doctor terminal 60, the control unit 11 changes the opening flag corresponding to the judging doctor in the relevant trial in the safety information management table 174 to “1”. To do. Then, after the emergency safety information or the safety bulletin is displayed on the determining medical terminal 60, the control unit 11 provides the determining medical terminal 60 with the image data requested for reference.

  When the emergency safety information or the safety bulletin is not associated with the clinical trial, the control unit 11 provides the determination medical terminal 60 with the image data requested to be referred to.

FIG. 5 shows a functional configuration of the clinical trial institution terminal 20.
As shown in FIG. 5, the clinical trial institution terminal 20 includes a control unit 21, an operation unit 22, a display unit 23, a communication unit 24, a ROM 25, a RAM 26, a storage unit 27, and the like. 28 is connected.

  The control unit 21, the operation unit 22, the display unit 23, the communication unit 24, and the RAM 26 have the same configuration as the control unit 11, the operation unit 12, the display unit 13, the communication unit 14, and the RAM 16 of the clinical trial data management apparatus 10, and are described. In order to avoid duplication, different configurations will be mainly described.

  The ROM 25 is composed of a nonvolatile semiconductor memory or the like, and stores a control program, parameters and files necessary for executing the program, and the like. For example, the ROM 25 stores a web browser program for realizing a web browser.

  The storage unit 27 is configured by an HDD, a semiconductor nonvolatile memory, or the like, and stores various data. The storage unit 27 stores clinical trial conditions 271, masking information 272, a patient ID correspondence table 273, and transmission history information 274 for each clinical trial.

The clinical trial condition 271 is information received from the clinical trial data management apparatus 10 and includes clinical trial protocol information such as a dosage in the relevant clinical trial, timing of medication / imaging, imaging apparatus information, imaging conditions, and the like. The clinical trial is conducted based on the clinical trial condition 271 in the clinical trial implementation medical institution.
The masking information 272 is information received from the clinical trial data management apparatus 10, and when the image data is transmitted from the clinical trial medical institution terminal 20 to the clinical trial data management apparatus 10 in the corresponding clinical trial, the masking information 272 is masked from the additional information of the image data. Contains items to be processed.
The patient ID correspondence table 273 includes, in each trial, a patient ID (patient identification information) of the patient in the clinical trial medical institution, and a trial ID (subject identification information) for distinguishing individual patients while anonymizing the patient in the trial. , Are associated with each other.
The transmission history information 274 is information in which an imaging date, an imaging timing, a sender, a transmission date and time, the number of images, and the like are associated with each of a plurality of patients (trial IDs) in the corresponding clinical trial.

  When transmitting the image data to the clinical trial data management apparatus 10, the control unit 21 uses the patient ID included in the incidental information attached to the image data as the clinical trial ID based on the patient ID correspondence table 273 of the clinical trial to be processed. At the same time, based on the masking information 272 of the target clinical trial, the contents of a predetermined item (the item to be masked included in the masking information 272) out of the incidental information attached to the image data are deleted.

FIG. 6 shows a functional configuration of the pharmaceutical company terminal 50.
As shown in FIG. 6, the pharmaceutical company terminal 50 includes a control unit 51, an operation unit 52, a display unit 53, a communication unit 54, a ROM 55, a RAM 56, a storage unit 57, and the like. It is connected.

  The control unit 51, the operation unit 52, the display unit 53, the communication unit 54, and the RAM 56 have the same configuration as the control unit 11, operation unit 12, display unit 13, communication unit 14, and RAM 16 of the clinical trial data management apparatus 10. In order to avoid duplication, different configurations will be mainly described.

  The ROM 55 is configured by a nonvolatile semiconductor memory or the like, and stores a control program, parameters and files necessary for executing the program, and the like. For example, the ROM 55 stores a web browser program and the like for realizing a web browser.

  The storage unit 57 is configured by an HDD, a semiconductor nonvolatile memory, or the like, and stores various data.

The control unit 51 transmits trial implementation information to the clinical trial data management apparatus 10 via the communication network N1, and requests a clinical trial.
The control unit 51 acquires the acquisition status of image data and the acquisition status of determination results for each of a plurality of timings from the clinical trial data management apparatus 10 via the communication network N1, and displays them on the display unit 53.

In FIG. 7, the functional structure of the judgment doctor terminal 60 is shown.
As shown in FIG. 7, the determination medical terminal 60 includes a control unit 61, an operation unit 62, a display unit 63, a communication unit 64, a ROM 65, a RAM 66, a storage unit 67, and the like. It is connected.

  The control unit 61, the operation unit 62, the display unit 63, the communication unit 64, and the RAM 66 have the same configuration as the control unit 11, operation unit 12, display unit 13, communication unit 14, and RAM 16 of the clinical trial data management apparatus 10. In order to avoid duplication, different configurations will be mainly described.

  The ROM 65 is configured by a nonvolatile semiconductor memory or the like, and stores a control program, parameters and files necessary for executing the program, and the like. For example, the ROM 65 stores a web browser program and the like for realizing a web browser.

  The storage unit 67 is configured by an HDD, a semiconductor nonvolatile memory, or the like, and stores various data.

When receiving a determination request from the clinical trial data management apparatus 10, the control unit 61 accesses the clinical trial data management apparatus 10 via the communication network N <b> 1 and displays a captured image on the display unit 63 based on the determination target image data. Display.
The control unit 61 transmits the determination result created by the determining doctor to the clinical trial data management apparatus 10 via the communication network N1.

[Operation in clinical trial system]
Next, the operation in the clinical trial system 100 will be described.
8 to 10 are ladder charts showing an outline of processing executed by each device of the clinical trial system 100. FIG. The processing in the clinical trial data management apparatus 10 is realized by software processing in cooperation with the control unit 11 and a program stored in the ROM 15, and the processing in the clinical trial medical institution terminal 20 is stored in the control unit 21 and the ROM 25. The process in the pharmaceutical company terminal 50 is realized by the software process in cooperation with the control unit 51 and the program stored in the ROM 55, and the process in the judgment medical terminal 60 is This is realized by software processing through cooperation between the control unit 61 and a program stored in the ROM 65.

  When accessing the clinical trial data management apparatus 10 in each of the clinical trial institution terminal 20, the pharmaceutical company terminal 50, and the judgment doctor terminal 60, a predetermined URL (Uniform Resource Locator) is input from the Web browser, and the clinical trial is performed. The data management device 10 provides display data for displaying a login screen to each device. The display data for various Web screens including a login screen includes HTML, style sheets, image data, scripts for causing each device to execute predetermined processing, and the like.

  In the clinical trial data management apparatus 10, user authentication is performed based on the user ID and password input from the login screen in each apparatus. Specifically, it is determined that the user authentication is OK when the input combination of the user ID and password matches the previously registered combination of user ID and password.

  First, in the pharmaceutical company terminal 50, based on the operation from the operation unit 52, the control unit 51 transmits the trial medical institution candidate list and the clinical trial condition to the clinical trial data management apparatus 10 via the communication unit 54 (step). S1). The clinical trial institution candidate list is a list of trial medical institutions that handle target cases.

In the clinical trial data management apparatus 10, the trial medical institution candidate list and the clinical trial conditions are received by the communication unit 14, and the clinical trial institution included in the trial medical institution candidate list is investigated by the control unit 11 (step S2). ). Specifically, the control unit 11 has an imaging apparatus that satisfies the clinical trial condition in the clinical trial medical institution for the clinical trial medical institution terminal 20 of the clinical trial medical institution included in the trial medical institution candidate list, Further, an inquiry as to whether or not it can be used continuously during the trial period is transmitted via the communication unit 14.
In addition, the clinical trial person in charge of the clinical trial contracting organization may inquire of the clinical trial medical institution whether the clinical trial can be conducted by telephone or FAX.

  In the clinical trial medical institution terminal 20, in response to an inquiry from the clinical trial data management device 10, the control unit 21 transmits the clinical trial medical institution information in its own facility to the clinical trial data management device 10 via the communication unit 24 ( Step S3). The information on the clinical trial site includes the name of the facility, the person in charge, contact information, imaging device information (specifications, repair / replacement schedule, etc.) and the like.

In the clinical trial data management apparatus 10, the trial medical institution information is received from the trial medical institution terminal 20 by the communication unit 14, and the clinical trial institution information is stored in the storage unit 17 by the control unit 11.
The clinical trial institution information may be input from the operation unit 12 of the clinical trial data management apparatus 10 based on information obtained from the clinical trial implementation medical institution.

  Next, the control unit 11 determines whether or not the clinical trial can be performed in the clinical trial medical institution in which the clinical trial medical institution terminal 20 is installed, based on the clinical trial implementation medical institution information. For example, based on information such as whether or not a CT that can be imaged with a slice thickness of 5 mm is held, and whether or not the CT apparatus is scheduled to be changed during the trial period, the trial medical institution is suitable for the trial. It is determined whether or not. And the control part 11 transmits a suitability determination report to the pharmaceutical company terminal 50 via the communication part 14 (step S4).

  In the pharmaceutical company terminal 50, based on the suitability determination report transmitted from the clinical trial data management apparatus 10, the clinical trial medical institution that conducts the clinical trial is determined. The decided investigational medical institution carries the investigational drug from a pharmaceutical company.

  Next, in the pharmaceutical company terminal 50, based on the operation from the operation unit 52, the control unit 51 transmits the clinical trial implementation information of the target clinical trial to the clinical trial data management apparatus 10 through the communication unit 54 (step). S5). Trial information includes the clinical trial protocol and related information describing the sponsor, clinical trial and control drug, clinical trial purpose, clinical trial summary, lesion name, case information, clinical trial conditions, clinical trial institution information, number of subjects, etc. Documentation is included.

  In the clinical trial data management apparatus 10, when clinical trial information is received by the communication unit 14, the clinical trial information is registered in the trail DB 171 of the storage unit 17 by the control unit 11 as a new clinical trial. Further, the control unit 11 determines a plurality of clinical trial IDs assigned to the subjects based on the number of subjects. Further, the control unit 11 determines items to be masked from the supplementary information of the image data based on the clinical trial implementation information, generates masking information, and stores the generated masking information in the trail DB 171 in association with the clinical trial. Is done. The items to be masked may be automatically determined based on the contents of the trial, or may be designated by an operation from the operation unit 12 of the operator of the trial data management apparatus 10.

  Next, in the clinical trial data management apparatus 10, the clinical trial condition, clinical trial ID, and masking information of the newly registered clinical trial are transmitted from the control unit 11 to the clinical trial medical institution terminal 20 through the communication unit 14 (step S6). ).

  In the trial medical institution terminal 20, the trial condition, trial ID, and masking information are received from the trial data management apparatus 10 by the communication unit 24. The control unit 21 stores the received clinical trial condition and masking information in the storage unit 27 as the clinical trial condition 271 and the masking information 272 corresponding to the new clinical trial. In addition, based on the received clinical trial ID, the control unit 21 creates a patient ID correspondence table 273 that associates the patient ID of the subject in the clinical trial medical institution with the clinical trial ID for the target clinical trial.

  In the clinical trial data management apparatus 10, the control unit 11 refers to the decision physician candidate correspondence table 173 stored in the storage unit 17, and based on the lesion name, case information, and the like included in the clinical trial implementation information, From the judgment doctor candidates, judgment doctor candidates corresponding to the specialized field related to the current clinical trial are extracted. The extracted judgment doctor candidates are displayed on the display unit 13 by the control unit 11. Then, by the operation of the operator of the clinical trial data management apparatus 10 from the operation unit 12, the judgment doctor who actually requests the judgment is selected from the extracted judgment doctor candidates, and the judgment doctor is determined (step S7). . For each clinical trial doctor who has been determined, cooperation with the clinical trial is consulted for each clinical trial by e-mail, telephone, direct visit, etc., and the doctor is determined when an agreement is obtained.

  Next, in the modality 40 of the clinical trial medical institution where the clinical trial medical institution terminal 20 is installed, an image of the target site of each subject before medication is taken (baseline). In the clinical trial medical institution terminal 20, the control unit 21 controls the patient in the clinical trial medical institution included in the incidental information of the image data of the medical image generated by the modality 40 based on the patient ID correspondence table 273 of the corresponding trial. The ID is replaced with the clinical trial ID, and the personal information is deleted from the incidental information of the image data based on the masking information 272 of the corresponding clinical trial. Then, the personal information is deleted by the control unit 21 and the image data with the clinical trial ID attached is transmitted to the clinical trial data management apparatus 10 via the communication unit 24 (step S8). Further, the control unit 21 transmits information indicating the photographing timing, photographing date, sender, transmission date and number of images, etc. to the clinical trial data management apparatus 10 together with the image data or as supplementary information attached to the image data. The Further, the control unit 21 records, for each trial ID (patient), the shooting date, the shooting timing, the sender, the transmission date and time, the number of images, and the like for each trial ID (patient) in the transmission history information 274.

  In the clinical trial data management apparatus 10, when information such as image data is received from the trial medical institution terminal 20 by the communication unit 14, the received image data is temporarily stored in the RAM 16 by the control unit 11. Information regarding the image data is registered in the trail DB 171. Specifically, in the trail DB 171, the imaging date, the sender, the transmission date and time, the number of images, and the like are stored in association with the corresponding imaging timing of the corresponding patient (trial ID) in the corresponding clinical trial.

  Next, the controller 11 checks whether or not the image data is suitable for image determination (step S9). Specifically, the control unit 11 determines whether or not the imaging conditions included in the incidental information attached to the image data match the imaging conditions corresponding to the corresponding clinical trial stored in the trail DB 171. In the incidental information attached to, whether the personal information corresponding to the item included in the masking information corresponding to the relevant trial stored in the trail DB 171 has been deleted, whether the imaging region is available, etc. Based on the above, it is determined whether or not the image data is suitable for image determination. For example, it is confirmed whether information described in a specific tag of DICOM image data is within a specified range. It is confirmed whether the slice thickness of CT (contents described in the tag No (0018, 0050)) is 5 mm or less, whether the shooting date is within a specified period from the previous shooting date, and the like.

  If the image data is not suitable for image determination, the control unit 11 determines that the image data is not suitable for image determination, and sends a request for retransmission of the image data via the communication unit 14 to the trial medical institution. It is transmitted to the terminal 20. The image data retransmission request may be notified by e-mail or telephone. If the image data is not suitable for image determination, the control unit 11 stores “0” in the QC confirmation result of the image data in the trail DB 171 and erases the image data from the RAM 16. .

  If the image data is suitable for image determination, the control unit 11 moves the image data stored in the RAM 16 to the image DB 172 and deletes it from the RAM 16. Then, the control unit 11 stores “1” in the QC confirmation result of the image data in the trail DB 171 and stores the storage location of the image data in the image DB 172 in the file path of the trail DB 171. When the QC confirmation result is “1” in the trail DB 171, the image data is disclosed to the judging doctor.

Next, in the clinical trial data management apparatus 10, the control unit 11 reports to the communication unit 14 that the image data obtained by photographing the relevant patient before medication in the relevant clinical trial and suitable for image determination is acquired. Is transmitted to the pharmaceutical company terminal 50 (step S10).
The acquisition status of the image data may be viewable from the pharmaceutical company terminal 50 when the clinical trial data management apparatus 10 is accessed from the pharmaceutical company terminal 50.

  Next, moving to FIG. 9, in the clinical trial data management apparatus 10, the control unit 11 requests the registration determination request to the determination medical terminal 60 corresponding to each of the plurality of determination doctors determined in step S <b> 7 for the relevant clinical trial. Is transmitted via the communication unit 14 (step S11). Specifically, an e-mail for a registration determination request is transmitted to an e-mail address corresponding to each determination doctor. Registration determination refers to determining whether the patient is suitable for administration of the investigational drug or is an appropriate image as a baseline image.

  Each judging doctor who has received the registration judgment request accesses the clinical trial data management apparatus 10 from the judging doctor terminal 60, and based on the image data to be judged, the display unit 63 of the judging doctor terminal 60 displays the patient before medication. Image (baseline) is displayed. The determination doctor performs image determination by measuring the longest diameter of the target lesion on the image, and inputs a registration determination result by an operation from the operation unit 62. The input registration determination result is transmitted by the control unit 61 to the clinical trial data management apparatus 10 via the communication unit 64 (step S12).

  It is also determined whether or not the patient is suitable for the clinical trial for the patient before medication. For example, when a tumor such as cancer is treated with medication, depending on the location of the tumor in the body, the position of the tumor may not be clear in the photographed image due to ascites, etc. It is determined whether or not the shape of the target tumor can be clearly confirmed from the image.

  In the clinical trial data management apparatus 10, when the registration determination result is received by the communication unit 14, the received registration determination result is stored in the trail DB 171 in association with the determination target image data by the control unit 11. Specifically, the received registration determination result is associated with the corresponding imaging timing (baseline) of the corresponding patient (trial ID) of the corresponding clinical trial and stored as the determination result of the corresponding determining doctor. . In addition, the control unit 11 transmits a report to the pharmaceutical company terminal 50 via the communication unit 14 that the determination result by the corresponding determining doctor at the corresponding imaging timing of the corresponding patient of the corresponding clinical trial is acquired.

Next, medication is started for the patient. When the registration determination based on the image is not performed, the medication is started without performing the processing of Step S11 and Step S12 after capturing an appropriate baseline image.
In the modality 40 of the clinical trial medical institution in which the clinical trial medical institution terminal 20 is installed, an image of the target site of each subject for the first time after medication is taken. In the clinical trial medical institution terminal 20, the image data of the medical image generated by the modality 40 is transmitted to the clinical trial data management apparatus 10 via the communication unit 24 (step S13).

  Since the processing of step S13 to step S15 is the same as the processing of step S8 to step S10 except that the shooting timing is different, description thereof will be omitted.

  Next, in the clinical trial data management apparatus 10, the control unit 11 sends an effect determination request to the determination medical terminal 60 corresponding to each of the plurality of determination doctors determined in step S7 for the corresponding clinical trial. (Step S16). Specifically, an e-mail for an effect determination request is transmitted to an e-mail address corresponding to each determination doctor.

  Each judging doctor who has received an effect judgment request accesses the clinical trial data management apparatus 10 from the judging doctor terminal 60, so that the patient image is displayed on the display unit 63 of the judging doctor terminal 60 based on the image data to be judged. Is displayed. The determination doctor performs image determination by measuring the longest diameter of the target lesion on the image, and inputs an effect determination result (effect determination report) by an operation from the operation unit 62. The result of the effect determination includes not only the measurement data of the size of the lesion, but also the presence / absence / size of the effect of the investigational drug (new guideline for determining the effect of treatment of solid cancer (RECIST guideline), revised version 1.1 reference). The input effect determination result is transmitted by the control unit 61 to the clinical trial data management apparatus 10 via the communication unit 64 (step S17).

  In the clinical trial data management apparatus 10, when the effect determination result is received by the communication unit 14, the received effect determination result is stored in the trail DB 171 in association with the determination target image data by the control unit 11. Specifically, the received effect determination result is stored in association with the corresponding imaging timing of the corresponding patient (trial ID) in the corresponding trial as the determination result of the corresponding determining doctor. In addition, the control unit 11 transmits a report indicating that the effect determination result by the corresponding determining doctor at the corresponding imaging timing of the corresponding patient of the corresponding clinical trial is acquired to the pharmaceutical company terminal 50 via the communication unit 14.

Next, in the clinical trial data management apparatus 10, it is determined by the control unit 11 based on the clinical trial execution information corresponding to the clinical trial whether or not the required number of imaging has been completed (step S18).
If the required number of imaging has not been completed (step S18; NO), the process returns to step S13, and the next imaging is performed in the modality 40 of the clinical trial institution. In the clinical trial institution terminal 20, the image data of the medical image generated by the modality 40 is transmitted to the clinical trial data management apparatus 10 via the communication unit 24.
In this way, the processes in steps S13 to S18 are repeated until the required number of times of shooting is completed.

  In step S18, when the required number of times of imaging has been completed (step S18; YES), the process moves to FIG. A comprehensive effect determination request is transmitted to the medical terminal 60 via the communication unit 14 (step S19). Specifically, an e-mail for a comprehensive effect determination request is transmitted to an e-mail address corresponding to each determination doctor.

  Each judging doctor who has received the request for comprehensive effect determination makes a comprehensive determination throughout the entire trial based on the image data and the measurement data of the lesion taken so far. (Refer to version 1.1 of the revised guideline for determining the therapeutic effect of solid cancer (RECIST guideline) 1.1). In addition, each judging doctor inputs the best overall effect (confirmation of the effect) by an operation from the operation unit 62 based on the overall effect determination result. The inputted overall effect determination result and the best overall effect are transmitted to the clinical trial data management apparatus 10 by the control unit 61 via the communication unit 64 (step S20).

  The overall effect assessment results include imaging time, target lesion information (increase rate (%), reduction rate (%), target lesion evaluation, etc.), non-target lesion information (non-target lesion evaluation, etc.), new lesion, comprehensive evaluation, etc. Is included.

  In the clinical trial data management apparatus 10, the comprehensive effect determination result and the best comprehensive effect received by the control unit 11 are associated with the corresponding patient of the corresponding clinical trial in the trail DB 171, and the comprehensive effect determination of the corresponding determining doctor is performed. Stored as result and best overall effect.

  Next, the comprehensive effect determination result and the best comprehensive effect for each patient by the control unit 11 for the corresponding clinical trial are sent to the pharmaceutical company terminal 50 via the communication unit 14 as the comprehensive effect determination report and the best comprehensive effect report. (Step S21).

  In the pharmaceutical company terminal 50, the control unit 51 displays the overall effect determination report and the best overall effect report on the display unit 53, and the overall effect determination report and the best overall effect report are confirmed. Based on the operation from the operation unit 52, the control unit 51 transmits a data lock instruction from the pharmaceutical company terminal 50 to the clinical trial data management apparatus 10 via the communication unit 54 (step S22).

  In the clinical trial data management apparatus 10, when a data lock instruction is received by the communication unit 14, the control unit 11 locks information related to the relevant clinical trial (step S23). Specifically, only browsing is permitted for information regarding the relevant clinical trials stored in the trail DB 171 and the image DB 172, and addition / change is prohibited. In addition, it is possible to back up information related to the clinical trial stored in the trail DB 171 and the image DB 172 to a non-rewritable medium such as a recording medium and store the state at that time.

  Next, the control unit 11 determines whether or not a predetermined period (data storage period) has elapsed since the data was locked (step S24). For example, for each trial, the date and time when the data was locked and the retention period were recorded, and whether the data retention period passed by comparing the period from the data lock date and time to the current date and the retention period Is judged. Alternatively, the storage end date may be recorded, and it may be determined whether the data storage period has elapsed based on whether the storage end date has been reached. If the data storage period has not elapsed since the data was locked (step S24; NO), the process returns to step S24.

  In step S24, when the data storage period has elapsed since the data was locked (step S24; YES), the control unit 11 confirms with the clinical trial client such as a pharmaceutical company and then the trail DB 171, the image DB 172, and the safety Information related to the relevant clinical trial stored in the sex information management table 174 is deleted (step S25).

Next, the control unit 11 transmits a business end notification about the corresponding clinical trial to the pharmaceutical company terminal 50 via the communication unit 14 (step S26).
Thus, the process in the clinical trial system 100 is completed.

  Next, emergency safety information registration processing executed in the clinical trial data management apparatus 10 will be described with reference to FIG.

  When a pharmaceutical company orders the creation and distribution of emergency safety information or safety bulletin (hereinafter referred to as emergency safety information) from the Ministry of Health, Labor and Welfare, it creates and issues emergency safety information. In the pharmaceutical company terminal 50, the control unit 51 transmits emergency safety information or the like (electronic data) for the drug used in the clinical trial to the clinical trial data management apparatus 10 via the communication unit 54.

  In the clinical trial data management apparatus 10, when the communication unit 14 receives emergency safety information or the like for the drug used in the clinical trial from the pharmaceutical company terminal 50 (step T <b> 1; YES), the control unit 11 performs the target clinical trial. On the other hand, emergency safety information and the like are registered (step T2). Specifically, the control unit 11 stores a data file such as emergency safety information in the storage unit 17, and in the safety information management table 174, “emergency safety” is associated with the clinical trial related to the corresponding drug. The current date / time is stored in “Registration Date / Time of Safety Information / Safety Bulletin”, and the storage location of the data file such as emergency safety information is stored in “File Path of Emergency Safety Information / Safety Bulletin”. The plurality of “determining physicians” corresponding to the clinical trial in the safety information management table 174 are registered with the determinating physicians determined in step S7, and the opening flag is set to “0: not opened”.

  In step T1, when emergency safety information or the like for the drug used in the clinical trial is not received from the pharmaceutical company terminal 50 (step T1; NO), or after step T2, the emergency safety information and the like registration process ends. .

  Next, with reference to FIG. 12, the determination time process executed in the clinical trial data management apparatus 10 will be described.

  Each determination doctor who has received the determination request (registration determination request, effect determination request, comprehensive effect determination request) accesses the clinical trial data management apparatus 10 from the determination medical terminal 60 and determines from the determination medical terminal 60 to the clinical trial data management apparatus 10. A reference request for target image data is transmitted.

  In the clinical trial data management apparatus 10, when a reference request for image data is received from the judging medical terminal 60 (step T11; YES), the safety information management table 174 is referred to by the control unit 11, and the relevant image data is related. The presence / absence of emergency safety information for the clinical trial (target clinical trial) is confirmed (step T12).

  When there is emergency safety information or the like for the target clinical trial (step T12; YES), the control unit 11 makes a determination of the determination medical terminal 60 that has made a reference request for the target clinical trial based on the safety information management table 174. It is determined whether or not the opening flag corresponding to the doctor is “0: not opened” (step T13).

  When the opening flag is “0: not opened” (step T13; YES), the control unit 11 notifies the judgment medical terminal 60 of emergency safety information and the like via the communication unit 14 (step T14). .

  When emergency safety information or the like is received, the judgment medical terminal 60 opens a data file such as emergency safety information or the like by an operation from the operation unit 62 and displays the emergency safety information or the like on the display unit 63. .

  Next, in the clinical trial data management apparatus 10, when an unsealing notification such as emergency safety information is received from the judging doctor terminal 60 (step T <b> 15; YES), the control unit 11 performs the target clinical trial of the safety information management table 174. The opening flag corresponding to the corresponding judgment doctor is changed to “1: opened” (step T16). Further, the control unit 11 notifies the pharmaceutical company terminal 50 of arrival of emergency safety information or the like to the corresponding determination doctor (step T17).

  In the pharmaceutical company, it is confirmed that emergency safety information or the like has been transmitted to the judging doctor by notification of arrival of emergency safety information or the like.

  After step T17, when there is no emergency safety information or the like for the target clinical trial at step T12 (step T12; NO), or when the opening flag is “1: opened” at step T13 (step T13). NO), the control unit 11 provides image data for which a reference request has been made to the judgment medical terminal 60 (step T18).

  In the judging doctor terminal 60, the image data requested for reference is displayed on the display unit 63, and image judgment by the judging doctor is performed.

  Next, the control unit 11 receives a determination result from the determining medical terminal 60 (step T19).

  After step T19 or in step T11, when the reference request for image data is not received from the determining medical terminal 60 (step T11; NO), the determination time process is ended.

  As described above, according to the present embodiment, in the clinical trial data management apparatus 10, emergency safety information or safety bulletin is registered for a drug used in a clinical trial. Only when information or the like is displayed on the judging doctor terminal 60, the image data requested for reference is provided to the judging doctor terminal 60. Therefore, emergency safety information in the clinical trial or safety breaking news is surely notified to the judging doctor. Can be done.

  Also, until emergency safety information and the like are displayed on the judging doctor terminal 60, image data related to the clinical trial is not provided to the judging doctor terminal 60, so that the judging doctor is surely notified of the emergency safety information and the like. can do.

  In addition, when the clinical trial data management apparatus 10 receives emergency safety information or safety bulletin for a drug used in a clinical trial from the pharmaceutical company terminal 50, the clinical trial data management apparatus 10 receives the received emergency safety information or safety bulletin for the drug. Can be registered in association with clinical trials related to

  The description in the above embodiment is an example of a clinical trial system according to the present invention, and the present invention is not limited to this. The detailed configuration and detailed operation of each device constituting the system can be changed as appropriate without departing from the spirit of the present invention.

  In the above description, an example in which a ROM is used as a computer-readable medium storing a program for executing each process is disclosed, but the present invention is not limited to this example. As other computer-readable media, a non-volatile memory such as a flash memory and a portable recording medium such as a CD-ROM can be applied. A carrier wave may be applied as a medium for providing program data via a communication line.

DESCRIPTION OF SYMBOLS 10 Clinical trial data management apparatus 11 Control part 12 Operation part 13 Display part 14 Communication part 17 Storage part 20 Clinical trial medical institution terminal 21 Control part 24 Communication part 27 Storage part 30 PACS
40 modality 50 pharmaceutical company terminal 51 control unit 54 communication unit 57 storage unit 60 judgment medical terminal 61 control unit 62 operation unit 63 display unit 64 communication unit 67 storage unit 100 clinical trial system 171 trail DB
172 Image DB
173 Decision doctor candidate correspondence table 174 Safety information management table N1 Communication network

Claims (4)

Image data obtained by imaging a target region of a patient in the clinical trial and connected to a judgment medical terminal used by a judgment physician for judging the effect of the investigational drug in a clinical trial via a network, and the image data A clinical trial data management device that manages the determination results determined by the determining physician based on the association with each other,
For the trial, emergency safety information or safety bulletin for the drug used in the trial, and unsealing information indicating whether the emergency safety information or safety bulletin is displayed on the judging medical terminal, , And a storage means for storing them in association with each other,
Whether or not the emergency safety information or the safety bulletin is displayed on the determination medical terminal based on the unsealing information stored in the storage means when a request for reference to image data is received from the determination medical terminal Control means for providing the image data for which the reference request has been made to the determination medical terminal when it is determined that the emergency safety information or the safety bulletin is displayed on the determination medical terminal;
A clinical trial data management device comprising:   When it is determined that the emergency safety information or the safety bulletin is not displayed on the judgment medical terminal, the control means provides the emergency safety information or the safety bulletin to the judgment medical terminal, and The clinical trial data management apparatus according to claim 1, wherein after the safety information or the safety bulletin is displayed on the determination medical terminal, the image data requested for the reference is provided to the determination medical terminal. Connected to the pharmaceutical company terminal installed in the pharmaceutical company requesting the clinical trial via the network so that data communication is possible,
When the control means receives emergency safety information or safety bulletin for the drug used in the clinical trial from the pharmaceutical company terminal, the control means corresponds to the received emergency safety information or safety bulletin with the clinical trial. The clinical trial data management apparatus according to claim 1 or 2, further comprising the storage means for storage. Determined by the determining doctor based on the determination doctor terminal used by the determining doctor who determines the effect of the investigational drug in the clinical trial, image data obtained by imaging the target region of the patient in the clinical trial, and the image data A clinical trial data management apparatus that associates and manages determination results with a clinical trial system connected to enable data communication via a network,
The clinical trial data management device comprises:
For the trial, emergency safety information or safety bulletin for the drug used in the trial, and unsealing information indicating whether the emergency safety information or safety bulletin is displayed on the judging medical terminal, , And a storage means for storing them in association with each other,
Whether or not the emergency safety information or the safety bulletin is displayed on the determination medical terminal based on the unsealing information stored in the storage means when a request for reference to image data is received from the determination medical terminal Control means for providing the image data for which the reference request has been made to the determination medical terminal when it is determined that the emergency safety information or the safety bulletin is displayed on the determination medical terminal;
Clinical trial system.

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