JP2017111637A - Clinical trial data management device and query management system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To make it easy to manage queries related to an image taken at a clinical test.SOLUTION: A clinical trial data management device 10 is connected with a medical facility terminal 30 installed in a medical facility to perform a clinical test for a new drug and an ICRO terminal 20 installed in an image commissioned clinical test execution institution via a communication network N1 in a data communication available manner. The clinical trial data management device receives a medical image involved in the clinical test transmitted by the medical facility terminal 30, has a storage unit store the received medical image, provides the ICRO terminal 20 with the medical image, receives a query related to the medical image from the ICRO terminal 20, has the storage unit store the received query in association with the medical image, provides the query for the medical facility terminal 30, and also provides the medical image associated with the query for the medical facility terminal 30.SELECTED DRAWING: Figure 1

Description

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

  When a drug candidate is newly developed by a pharmaceutical company, a clinical trial (clinical trial) is performed to confirm the efficacy and safety of the drug for a plurality of patients. In a medical facility that conducts a clinical trial, a patient (subject) who cooperates in the clinical trial is administered and treated, and data related to the clinical trial result is collected.

  The clinical trial is carried out by a clinical trial client (pharmaceutical company), a medical facility, a CRO (Contract Research Organization), a judging doctor, and the like. CRO refers to a person who has commissioned clinical trial work from a clinical trial client, such as requesting clinical trials to a medical facility, preparation for implementation, and management. For clinical trials that determine the effects of drugs using images, ICRO (Image Contract Research Organization) specializing in images commissions work related to clinical trials.

  In the case of a clinical trial using an image, a site to be clinical trial is imaged in a medical facility by CT (Computed Tomography), CR (Computed Radiography), MRI (Magnetic Resonance Imaging) or the like. Conventionally, after anonymization is performed on image data used in a clinical trial, a recording medium on which the image data is recorded is sent from a medical facility to ICRO by mail. In recent years, in order to improve convenience, a system for transmitting image data related to a clinical trial using a wide area network line has been used.

  Specifically, image data is transmitted from a medical facility to an FTP (File Transfer Protocol) server, and the image data stored in the FTP server is referred to by ICRO. In ICRO, if a defect is found as a result of quality confirmation (QC) performed on image data, an inquiry called a query is made to a medical facility. E-mail is mainly used as an inquiry method. At this time, a screen capture image including a defective image is pasted into a document created by a general-purpose document creation application, and an explanation is attached to an e-mail to give a correction instruction to the image data. Be notified. In the medical facility, the deficiencies pointed out are improved and the image data is retransmitted.

  Further, as a system that does not involve image transmission, for example, in a clinical trial data management system in which information processing apparatuses in a pharmaceutical company, hospital, and clinical trial data management center are connected by a network, It is proposed that a hospital makes corrections or answers to clinical trial data in response to an inquiry from a pharmaceutical company (see Patent Document 1).

JP 2007-299150 A

  However, when an image is captured in a clinical trial, it is difficult to manage the captured image and a query for the image. In clinical trials involving imaging, there are many queries related to images such as the imaging method and timing, but if the imaging time is missed, the trial for the subject must be interrupted, A problem will occur.

  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 facilitate the management of queries for images taken in clinical trials.

  In order to solve the above-mentioned problems, the invention described in claim 1 includes a first terminal installed in a medical facility for conducting a clinical trial for a new drug, and a second terminal installed in an image-contract clinical trial conducting organization. A clinical trial data management apparatus connected to enable data communication via a network, receiving a medical image related to a clinical trial transmitted from the first terminal, and storing the received medical image in a storage means Means, an image providing means for providing the medical image stored in the storage means to the second terminal, a query for the medical image provided to the second terminal from the second terminal, and the received query to the second terminal A query registration unit for storing in the storage unit in association with the medical image; and a query stored in the storage unit is provided to the first terminal, and the query And a query providing means for providing a medical image that is associated with the first terminal.

  The invention according to claim 2 is the clinical trial data management apparatus according to claim 1, wherein the annotation drawn in the point indicated in the query for the medical image on the medical image provided from the second terminal to the second terminal. An annotation registration unit that stores information indicating the received annotation in association with the medical image and stores the information in the storage unit, and the query providing unit stores the medical image associated with the query as the medical image. When providing to the first terminal, the annotation is added to the medical image.

  According to a third aspect of the present invention, in the clinical trial data management apparatus according to the first or second aspect, the query registration unit includes the second terminal to the second terminal when there are a plurality of medical images corresponding to the query. Receiving the information indicating the designated key image from the plurality of medical images provided, and storing the information indicating the received key image in the storage unit in association with the query, wherein the query providing unit includes the query and When the plurality of associated medical images are provided to the first terminal, the key image is initially displayed.

  According to a fourth aspect of the present invention, in the clinical trial data management apparatus according to any one of the first to third aspects, a totaling unit that totals the queries stored in the storage unit is provided.

  According to a fifth aspect of the present invention, in the clinical trial data management apparatus according to the fourth aspect of the invention, the counting unit is configured such that the counting unit is a medical facility unit to which the medical image is transmitted or the medical image is transmitted when the medical image is transmitted. Queries are aggregated for each terminal operator.

  According to a sixth aspect of the present invention, in the clinical trial data management apparatus according to the fourth or fifth aspect, the tabulation unit counts only the queries whose date and time stored in the storage unit are within a specified period. To do.

  According to a seventh aspect of the present invention, in the clinical trial data management apparatus according to any one of the fourth to sixth aspects, the tabulating unit tabulates a query for each type of query occurrence.

  The invention according to claim 8 is a network in which a first terminal installed in a medical facility that conducts a clinical trial for a new drug, a second terminal installed in a contracted clinical trial institution, and a clinical trial data management device. The first terminal is provided with an image transmission means for transmitting a medical image related to a clinical trial to the clinical trial data management apparatus, and the clinical trial data management apparatus comprises: An image registration means for storing a medical image received from the first terminal in a storage means; and an image providing means for providing the medical image stored in the storage means to the second terminal. Comprises a query transmission means for transmitting a query for a medical image provided from the clinical trial data management device to the clinical trial data management device, and the clinical trial data management device comprises: A query registration unit for storing the query received from the two terminals in the storage unit in association with the medical image provided to the second terminal, and providing the query stored in the storage unit to the first terminal; Query providing means for providing the first terminal with a medical image associated with the query.

  The invention according to claim 9 is the query management system according to claim 8, wherein the second terminal displays a medical image provided from the clinical trial data management device, and is displayed on the display means. The clinical trial data includes: a drawing unit that draws an annotation at a point indicated in a query for the medical image on the medical image; and an annotation transmission unit that transmits information indicating the drawn annotation to the clinical trial data management apparatus. The management apparatus includes an annotation registration unit that stores information indicating the annotation received from the second terminal in the storage unit in association with the medical image provided to the second terminal, and the query providing unit includes the query and When providing the associated medical image to the first terminal, the annotate is displayed on the medical image. To provide by adding ® down.

  The invention according to claim 10 is the query management system according to claim 8 or 9, wherein when there are a plurality of medical images corresponding to the query, the second terminal designates a key image from the plurality of medical images. Information indicating the key image received from the second terminal. The specifying means for transmitting the information and the key image transmitting means for transmitting information indicating the specified key image to the clinical trial data management apparatus. Is associated with the query and stored in the storage means, and the query providing means initially displays the key image when providing the first terminal with a plurality of medical images associated with the query.

  According to the present invention, it is possible to easily manage queries for images taken in clinical trials.

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 an example of a data model in a clinical trial data management apparatus. It is an example of the process managed by progress management information. It is a figure which shows the authority of each user. It is a block diagram which shows the functional structure of an ICRO terminal, a medical facility terminal, a pharmaceutical company terminal, and a judgment doctor terminal. It is a ladder chart which shows the query registration process performed by a clinical trial data management apparatus, an ICRO terminal, and a medical facility terminal. It is a ladder chart which shows the query registration process performed by a clinical trial data management apparatus, an ICRO terminal, and a medical facility terminal. It is an example of the query reference screen displayed on a medical facility terminal. It is an example of the image reference screen displayed on a medical facility terminal. It is a ladder chart which shows the query progress confirmation process performed with a clinical trial data management apparatus and a pharmaceutical company terminal. It is a ladder chart which shows the query total process performed by a clinical trial data management apparatus and an ICRO terminal. It is an example of the query total screen displayed on an ICRO terminal.

  Hereinafter, an embodiment of a query management 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 as a query management system in the present embodiment.
As shown in FIG. 1, the clinical trial system 100 includes a clinical trial data management apparatus 10, an ICRO terminal 20 as a second terminal installed in an ICRO (Image Contract Research Organization), and a clinical trial for a new drug. The medical facility terminal 30, the PACS 40, and the modality 50 as the first terminal installed in the medical facility that conducts the test, the pharmaceutical company terminal 60 installed in the pharmaceutical company, and the judging doctor who determines the effect and safety of the new drug And a judgment doctor terminal 70 to be used. The clinical trial data management device 10, the ICRO terminal 20, the medical facility terminal 30, the pharmaceutical company terminal 60, and the judging doctor terminal 70 are connected to be able to perform data communication via a communication network N1 such as the Internet. In FIG. 1, each device is illustrated one by one, but the number of ICRO terminals 20, medical facility terminals 30, pharmaceutical company terminals 60, and judging doctor terminals 70 is not particularly limited.

  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 receives from the medical facility terminal 30 image data of a medical image obtained by imaging a target region of a patient before and after medication. The clinical trial data management apparatus 10 transmits a request for quality confirmation (hereinafter referred to as QC) for image data to the ICRO terminal 20 and receives a confirmation result (hereinafter referred to as QC result) from the ICRO terminal 20. The clinical trial data management apparatus 10 transmits an image data determination request to the determining doctor terminal 70 and receives the determination result determined by the determining doctor from the determining doctor terminal 70.

  The ICRO terminal 20 is a computer device for a user belonging to ICRO to perform registration operation and browsing of information related to clinical trials and QC work. The ICRO terminal 20 issues a query when there is a problem with the medical image transmitted from the medical facility terminal 30 to the clinical trial data management apparatus 10. A query is an inquiry for information handled in a clinical trial. For example, the query includes a correction instruction when information is incomplete.

  QC is a check of whether or not a medical image is suitable for image determination. Specifically, whether or not the imaging conditions included in the supplementary information attached to the medical image matches the imaging conditions corresponding to the clinical trial, or the masking corresponding to the clinical trial in the supplementary information attached to the medical image. Whether or not the medical image is suitable for image determination is determined based on whether or not the personal information corresponding to the item included in the information has been deleted, whether or not the imaging region has been prepared, and the like. For example, based on information described in a specific tag of image data conforming to the DICOM (Digital Imaging and Communications in Medicine) standard, the CT slice thickness is 5 mm or less, or the shooting date is the previous shooting date. To check if it is within the specified period.

  In QC, items that are automatically determined based on supplementary information of medical images may be separated from items that are determined by the operator. For example, the operator may determine whether personal information is masked or whether all necessary images are available. With respect to the items determined by the operator, it is determined that the medical image is suitable for image determination by accepting an operation instruction to approve the confirmation of the image.

The medical facility terminal 30, the PACS 40, and the modality 50 are configured to be connected to each other so as to be able to perform data communication with each other via an in-facility network N2 such as a LAN (Local Area Network).
For security reasons, the medical facility terminal 30 connected to the external network (communication network N1), the PACS 40, and the modality 50 may not be connected. In that case, image data may be transferred between apparatuses using a medium such as a CD-R or a DVD-R.

  The medical facility terminal 30 transmits the image data of the medical image generated by the modality 50 to the clinical trial data management apparatus 10.

  The PACS 40 stores medical image image data and the like generated by the various modalities 50, and provides medical image image data and the like in response to a request from an external device.

The modality 50 captures a patient's determination target region as a subject, digitally converts the captured image, and generates image data of a medical image. The modality 50 is configured by, for example, CT, CR, MRI and the like. The modality 50 attaches additional information to a medical image by writing auxiliary information such as patient information and imaging information in the header of the image file of the medical image in accordance with the DICOM standard.
In a medical facility, an order of imaging conditions is generated by HIS (Hospital Information System) or RIS (Radiology Information System). Imaging conditions are set for each clinical trial and are provided to medical facilities in writing. In a medical facility, an order is registered in the HIS / RIS according to the imaging conditions, and imaging is performed by the modality 50.

  The pharmaceutical company terminal 60 is a computer device used by a pharmaceutical company person requesting a clinical trial. The pharmaceutical company terminal 60 is used when requesting clinical trial instructions from the clinical trial data management apparatus 10 or confirming the progress of each clinical trial.

  The judging doctor terminal 70 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. The determination result includes information indicating the effect and safety of the investigational drug determined from the image data. For example, the determination result includes information indicating a change in the longest diameter of the target lesion in the image and a degree of the drug effect.

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 serves as a web server that provides various web screens to the web browser by communicating with the web browser installed in the ICRO terminal 20, the medical facility terminal 30, the pharmaceutical company terminal 60, and the judgment doctor terminal 70 using the HTTP protocol. A Web server program for realizing the above functions, an application program that runs on the Web server, and provides a clinical trial support system to the operator of each device 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.

  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 includes project information D1, facility information D2, user information D3, device information D4, subject information D5, VISIT information D6, image management information D7, image data D8, annotation information D9, progress management information D10, QC management information D11 and query management information D12 are stored.

FIG. 3 shows an example data model.
The project information D1 is basic information registered for each clinical trial (clinical trial) project. The project information D1 includes the drug subject to clinical trial, period, dosage, dosage timing, imaging timing (before administration, every 4 weeks after administration, every 8 weeks, etc.), imaging conditions (imaging site, imaging direction, slice) Thickness etc.).

  The facility information D2 is information regarding a medical facility where a clinical trial is performed. The facility information D2 includes a medical facility name, a location, a contact address, and the like. The facility information D2 is associated with the project information D1.

  The user information D3 is information relating to a user who uses the clinical trial support system. The user information D3 includes the user's name, user ID, password, affiliation, mail address, and the like. User information D3 of a user belonging to a medical facility is associated with the facility information D2. On the other hand, user information D3 of a user who does not belong to a medical facility (user such as ICRO) is not associated with the facility information D2. The user information D3 is associated with the project information D1.

  The device information D4 is information related to a device (modality) installed in each medical facility for taking an image. The device information D4 includes the device type, performance (how many slices can be imaged within CT in CT, etc.), and the like. The device information D4 is associated with the facility information D2.

  The subject information D5 is information relating to a subject that belongs to each medical facility and is a subject of a clinical test, and is managed by a subject ID. The subject information D5 includes a subject ID, an administration start date, and the like. Moreover, age, sex, etc. may be contained in the subject information D5. The subject information D5 is associated with the facility information D2.

  The VISIT information D6 is information indicating the photographing time determined for each subject. The VISIT information D6 is associated with the subject information D5.

  The image management information D7 is information for managing medical images included in each VISIT. The image management information D7 includes the medical facility / user who transmitted the medical image, the image identification information and storage location of the image data D8 included in each VISIT, information indicating the key image, and the like. The image management information D7 is associated with the VISIT information D6. In the image management information D7, one or a plurality of medical images are managed for one VISIT.

  Image data D8 is image data of a medical image transmitted from a medical facility to each VISIT. The image data D8 is associated with the image management information D7.

  The annotation information D9 is information indicating the point indicated by the query drawn on the medical image when the query is issued. The annotation information D9 includes arrows, marks, characters, symbols, information indicating their positions, etc. drawn on the medical image. The annotation information D9 is associated with the VISIT information D6 and the image management information D7.

  The progress management information D10 is information for managing the progress status of each VISIT. The progress management information D10 is associated with project information D1, device information D4, and VISIT information D6.

  FIG. 4 shows an example of processes managed by the progress management information D10. The progress management information D10 includes information indicating which process of each process P1 to P13 has progressed to each case. When each process is completed, it is possible to determine up to which process is completed by making a transition to the next state.

“Unreceived VISIT (process P1)” is a state before an image is transmitted from the medical facility to the clinical trial data management apparatus 10.
“Waiting for ICRO primary QC (process P2)” is a state in which an image is transmitted from the medical facility to the clinical trial data management apparatus 10. Here, primary QC by ICRO is performed. The primary QC is a simple confirmation of whether or not personal information is included in the incidental information of a medical image.
“ICRO primary QC completion / secondary QC waiting (process P3)” is a state in which the primary QC (minimum QC) is completed. Here, secondary QC by ICRO is performed. Secondary QC is confirmation of whether a medically necessary site | part is contained in the image.
“Waiting for QC result confirmation (process P4)” is a state in which the secondary QC is finished. Here, the ICRO manager is waiting for approval.

“Preparing judgment case list (step P5)” is a state before creation of a judgment case list by ICRO.
“Waiting for confirmation of judgment case list (process P6)” is a state of waiting for confirmation of the created judgment case list by the trial client.

“Waiting for central determination request (process P7)” is a state of waiting for a central determination request.
“Central determination in progress (step P8)” is a state of waiting for execution of central determination by the central determination doctor.
“Waiting for confirmation of central determination result (process P9)” is a state of waiting for signature of the determination result by the central determination physician.
“Checking the central determination result report (process P10)” is a state of waiting for confirmation of the determination result report created by the central determination doctor.
“Completion of determination target case (process P11)” is a state in which ICRO determines that there is no problem after confirming the determination result report.

“Non-executable VISIT (process P12)” is a state in which the image is not taken for the scheduled VISIT and is thus not determined.
The “center determination excluded case (process P13)” is a state in which the case is excluded from the determination target by the clinical trial client.

  The QC management information D11 is information for managing the QC result for each VISIT. The QC result is information indicating whether or not a medical image obtained by each VISIT is suitable for image determination. The QC management information D11 is associated with the project information D1 and the VISIT information D6.

  The query management information D12 is information for managing a query state for a medical image or device. The query management information D12 includes inquiry contents, generation type, registration date / time, issuer affiliation / user, answerer (notification destination) affiliation / user, answer deadline, query status, and the like. When the query is for an image, the query management information D12 is associated with the image management information D7. When the query is for a device, the query management information D12 is associated with the device information D4. The query management information D12 is associated with the project information D1.

  The inquiry content is the body of the query, and is the content that the query issuer wants to make an inquiry to the notification destination.

The occurrence type is a classification based on the cause of the query being issued. Queries are classified into occurrence types such as “facility”, “subject”, “case image”, and “modality”, for example.
The occurrence type “facility” is a case where there is a problem when registering the facility information D2, and is an occurrence type corresponding to the query before the start of the clinical trial.
The occurrence type “subject” is a case where there is a problem when registering the subject information D5, and is an occurrence type corresponding to the query before the start of the clinical trial.
The occurrence type “case image” is a case where there is a problem with the image and a query is issued. In this case, it is further classified into “out-of-period imaging”, “insufficient imaging region”, “insufficient imaging conditions”, “insufficient imaging information (information in image tag)”, “insufficient anonymization”, etc. It is good as well.
The occurrence type “modality” is a case where a query is issued due to a problem in the modality (device). In this case, it may be further classified into “use of unregistered modality”, “insufficient information at the time of modality registration”, “insufficient photographed image at the time of modality registration”, and the like.

The registration date and time is the date and time when the query (query management information D12) is stored in the storage unit 17.
The issuer's affiliation is the facility (ICRO) to which the user who issued (created) the query belongs.
The issuer user is the user who issued (created) the query.
The affiliation on the answering side is a medical facility to which a user who is notified of a query belongs, and is a medical facility where a medical facility terminal 30 to which a medical image to be queried is transmitted is installed.
The answering user is a user who is a query notification destination, and is an operator of the medical facility terminal 30 when a medical image to be queried is transmitted.
The answer deadline is a deadline set by the user who issued the query.

  The query status is information indicating the progress status of the registered query. For example, the query status takes a status such as query issuance, answer waiting, answer completed, query completed, or the like. “Query issuance” is a state in which the query is registered, but the query notification destination user has not yet referred to the query. “Waiting for answer” is a state in which the query notification user has already referred to the query but has not yet answered. “Responded” is a state in which the query notification user has finished answering the query and is waiting for re-QC. “Query completed” is a state in which the problem has been solved as a result of re-QC.

The storage unit 17 stores authority for each user managed by the clinical trial data management apparatus 10.
FIG. 5 shows the authority of each user. Each link name shown in FIG. 5 corresponds to a link button that changes from the main screen to the function screen when logging into the clinical trial support system. Control is performed so that only link buttons corresponding to functions for which the user has authority are displayed according to the authority of the user. FIG. 5 shows the highest-level authority management. Actually, more detailed authority control is performed in each link destination screen.

“Facility information search / registration” is an authority to search and register information related to medical facilities where clinical trials are performed. In the transition destination screen, the clinical trial facility is restricted so that only information on its own medical facility can be displayed. In addition, on the transition destination screen, information cannot be registered / updated except for the clinical trial facility.
“Image transmission” is an authority to transmit an image from the clinical trial facility.
“Image transmission history” is an authority to search and refer to a history of transmitted images. The clinical trial facility can refer only to images transmitted from its own medical facility.
“VISIT search” is an authority to search VISIT and refer to the progress of VISIT. The trial medical facility can refer only to the VISIT of its own medical facility.

  The “judgment case list” is an authority to refer to the judgment case list. In this system, it is assumed that a case will be made after a certain number of cases have accumulated. A request list is created in units from the decision case list, and the request from the trial client is obtained for each request list. It is a mechanism to do. The clinical trial sponsor performs management such as not making a determination request for an image of a subject who has dropped out (due to death or failure to take a picture during the period).

“Central determination guideline” is an authority to display a guideline to be confirmed by the central determination doctor.
The “central determination request list” is an authority to refer to a list of determination requests for each determining doctor.

The “correction history list” is an authority to search a correction history such as facility information and determination results. In order to prevent falsification of data, when the facility information / judgment result is modified, the history can be referred to.
The “progress management ledger” is an authority to search and display the progress information of the determination.
“Issuing a query” is an authority to issue a new query.
“Query search” is an authority to search a query.

  The control unit 11 receives the medical image related to the clinical test transmitted from the medical facility terminal 30 via the communication unit 14 and causes the storage unit 17 to store the received medical image. That is, the control unit 11 functions as an image registration unit.

  The control unit 11 requests the ICRO terminal 20 for the QC of the medical image received from the medical facility terminal 30 and acquires the QC result determined by the ICRO from the ICRO terminal 20 via the communication network N1. The obtained QC result is stored in the storage unit 17 in association with the determination-target medical image.

The control unit 11 provides the medical image stored in the storage unit 17 to the ICRO terminal 20. That is, the control unit 11 functions as an image providing unit.
The control unit 11 receives a query for a medical image provided from the ICRO terminal 20 to the ICRO terminal 20, and stores the received query in the storage unit 17 in association with the medical image. That is, the control unit 11 functions as a query registration unit.
Further, the control unit 11 receives information indicating a key image designated from a plurality of medical images in the ICRO terminal 20, and stores the information indicating the key image in the storage unit 17 in association with the query.

  The control unit 11 receives information indicating an annotation from the ICRO terminal 20 and stores the information indicating the annotation in the storage unit 17 in association with the medical image provided to the ICRO terminal 20. That is, the control unit 11 functions as an annotation registration unit.

The control unit 11 provides the medical facility terminal 30 with the query stored in the storage unit 17 and provides the medical facility terminal 30 with a medical image associated with the query. That is, the control unit 11 functions as a query providing unit.
The control unit 11 initially displays the key image when providing the medical facility terminal 30 with a plurality of medical images associated with the query. “Initial display of key image” means to display a medical image in a state where the key image is displayed as an initial state. The key image may be displayed so as to be distinguishable from other images, or only the key image may be displayed.
When providing the medical image associated with the query to the medical facility terminal 30, the control unit 11 adds the annotation to the medical image based on the information indicating the annotation associated with the medical image. To do.

  The control unit 11 acquires the determination result determined by the determining doctor based on the medical image stored in the storage unit 17 from the determining medical terminal 70 via the communication network N1, and uses the acquired determination result as the determination target. Are stored in the storage unit 17 in association with the medical image.

The control unit 11 tabulates the queries stored in the storage unit 17. That is, the control unit 11 functions as a counting unit.
The control unit 11 aggregates the queries in units of medical facilities where the medical facility terminals 30 to which the medical images are transmitted are installed or in units of operators of the medical facility terminals 30 when the medical images are transmitted.
The control unit 11 aggregates only queries in which the registration date and time of the query stored in the storage unit 17 is within a specified period.
The control unit 11 aggregates the queries for each query generation type.

As shown in FIG. 6, the ICRO 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. Has been.
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 includes an HDD, a nonvolatile semiconductor memory, and 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 ROM 25 and the storage unit 27 may be configured in the same HDD.

The display unit 23 displays the medical image provided from the clinical trial data management apparatus 10.
The control unit 21 transmits a query for the medical image provided from the clinical trial data management apparatus 10 to the clinical trial data management apparatus 10 via the communication unit 24. That is, the control unit 21 functions as a query transmission unit.

The operation unit 22 is used when an annotation is drawn at a point indicated in a query for the medical image on the medical image displayed on the display unit 23. That is, the operation unit 22 functions as a drawing unit.
The control unit 21 transmits information indicating the drawn annotation to the clinical trial data management apparatus 10 via the communication unit 24. That is, the control unit 21 functions as an annotation transmission unit.

The operation unit 22 is used when a key image is designated from the plurality of medical images when there are a plurality of medical images corresponding to the query. That is, the operation unit 12 functions as a designation unit.
The control unit 21 transmits information indicating the designated key image to the clinical trial data management apparatus 10 via the communication unit 24. That is, the control unit 21 functions as a key image transmission unit.

As shown in FIG. 6, the medical facility terminal 30 includes a control unit 31, an operation unit 32, a display unit 33, a communication unit 34, a ROM 35, a RAM 36, a storage unit 37, and the like. It is connected.
Since each part of the medical facility terminal 30 has the same configuration as each part of the ICRO terminal 20, detailed description thereof is omitted.
The communication unit 34 further transmits / receives data to / from an external device connected via the in-facility network N2.

  The storage unit 37 stores clinical trial conditions, masking information, a patient ID / subject ID correspondence table, and the like for each clinical trial.

The masking information is information received from the clinical trial data management device 10 and is an item masked from the supplementary information of the medical image when the medical image is transmitted from the medical facility terminal 30 to the clinical trial data management device 10 in the relevant clinical trial. including.
The patient ID-subject ID correspondence table includes a patient ID (patient identification information) of a patient in a medical facility and a subject ID (subject identification information) for distinguishing individual patients while anonymizing the patient in the trial in each trial. , Are associated with each other.

  The control unit 31 transmits medical images related to the clinical trial to the clinical trial data management apparatus 10 via the communication unit 34. That is, the control unit 31 functions as an image transmission unit.

  When transmitting the medical image to the clinical trial data management apparatus 10, the control unit 31 determines the patient ID included in the incidental information attached to the medical image based on the subject clinical patient ID-subject ID correspondence table. In addition to the ID, the content of a predetermined item (the item to be masked included in the masking information) is deleted from the auxiliary information attached to the medical image based on the masking information of the target clinical trial.

As shown in FIG. 6, the pharmaceutical company 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.
Since each part of the pharmaceutical company terminal 60 has the same configuration as each part of the ICRO terminal 20, detailed description thereof is omitted.

As shown in FIG. 6, the determining medical terminal 70 includes a control unit 71, an operation unit 72, a display unit 73, a communication unit 74, a ROM 75, a RAM 76, a storage unit 77, and the like. It is connected.
Since each part of the judgment medical terminal 70 is the same structure as each part of the ICRO terminal 20, detailed description is abbreviate | omitted.

When receiving a determination request from the clinical trial data management apparatus 10, the control unit 71 accesses the clinical trial data management apparatus 10 via the communication network N1, and based on the determination target image data, displays a medical image on the display unit 73. Display.
The control unit 71 transmits the determination result created by the determining physician 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.
When accessing the clinical trial data management apparatus 10 in each of the ICRO terminal 20, the medical facility terminal 30, the pharmaceutical company terminal 60, and the judging doctor terminal 70, a predetermined URL (Uniform Resource Locator) is input from the Web browser. The clinical trial data management apparatus 10 provides display data for displaying a login screen to each apparatus. 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.

  7 and 8 are ladder charts showing query registration processing executed by the clinical trial data management apparatus 10, the ICRO terminal 20, and the medical facility terminal 30. FIG. The processing in the clinical trial data management apparatus 10 is realized by software processing in cooperation with the control unit 11 and the program stored in the ROM 15, and the processing in the ICRO terminal 20 is performed by the control unit 21 and the program stored in the ROM 25. The processing in the medical facility terminal 30 is realized by software processing in cooperation with the control unit 31 and the program stored in the ROM 35.

First, in the medical facility terminal 30, the login screen provided from the clinical trial data management apparatus 10 is displayed on the display unit 33, and the user ID and password of the operator are input from the operation unit 32, and login to the clinical trial support system is performed. (Step S1).
In the clinical trial data management apparatus 10, user authentication is performed, and display data for displaying the main screen on the medical facility terminal 30 is provided.

  Next, in the medical facility terminal 30, when “image transmission” is designated from the main screen displayed on the display unit 33 by an operation from the operation unit 32, the image transmission screen is displayed on the display unit 33 (step S 30). S2).

  Next, in the modality 50 of the medical facility where the medical facility terminal 30 is installed, an image of the target region of the subject is taken, and the control unit 31 of the medical facility terminal 30 performs a medical image from the modality 50 via the communication unit 34. Is captured (step S3).

Next, in the medical facility terminal 30, VISIT (number of times of imaging) corresponding to the medical image is selected by an operation from the operation unit 32 (step S4).
Next, in the medical facility terminal 30, examination information corresponding to the medical image is input by an operation from the operation unit 32 (step S5). The inspection information includes a modality type, imaging conditions, and the like. Note that examination information stored in advance may be acquired instead of the input from the operation unit 32.

Next, in the medical facility terminal 30, the control unit 31 associates the image data of the medical image with the information indicating VISIT selected in step S4 and the examination information input in step S5. Is transmitted to the clinical trial data management apparatus 10 (step S6).
Prior to the transmission of the image data, the clinical trial medical treatment included in the incidental information of the image data of the medical image generated by the modality 50 by the control unit 31 based on the patient ID-subject ID correspondence table of the corresponding trial. The patient ID in the facility is replaced with the subject ID, and the personal information is deleted from the incidental information of the image data based on the masking information of the corresponding clinical trial.

  In the clinical trial data management apparatus 10, when image data of a medical image is received from the medical facility terminal 30 by the communication unit 14, the control unit 11 receives the received image data of the medical image as image data D8 in the storage unit 17. Registered (step S7). Further, based on the information indicating the subject ID and VISIT included in the information received from the medical facility terminal 30 by the control unit 11, the image management associated with the corresponding VISIT information D6 and corresponding to the received image data. Information D7 is registered. Specifically, the image management information D7 is included in the medical facility where the medical facility terminal 30 that transmitted the image is installed, the operator of the medical facility terminal 30 at the time of image transmission (the logged-in user), and the corresponding VISIT. The image identification information and the storage location of the image data D8 to be stored are stored in the storage unit 17.

  Next, in the clinical trial data management apparatus 10, the control unit 11 notifies the person in charge of the ICRO terminal 20 through the communication unit 14 of a mail requesting QC (step S8). The QC request destination user may be determined in advance, or may be selected from a plurality of candidates at the time of mail transmission. The mail address corresponding to the QC request destination user is read from the user information D3, and the mail is transmitted to the mail address. The e-mail contains a URL for logging in to the clinical trial support system.

  In the ICRO terminal 20, mail is received from the clinical trial data management apparatus 10 by the communication unit 24. When the URL in the mail is clicked from the operation unit 22 by the operator of the ICRO terminal 20 while the mail is displayed on the display unit 23, a login screen provided from the clinical trial data management apparatus 10 is displayed on the display unit 23. Is displayed. Then, the user ID and password of the operator are input from the operation unit 22, and login to the clinical trial support system is performed (step S9).

In the clinical trial data management apparatus 10, user authentication is performed and a medical image reference screen for referring to the medical image registered in step S7 is provided to the ICRO terminal 20.
In the ICRO terminal 20, a medical image reference screen is displayed on the display unit 23 (step S10). Note that, after logging in, instead of transitioning directly to the medical image reference screen, the operator may designate a transition destination from the main screen.

  Next, in the ICRO terminal 20, a key image is designated from among medical images that are QC targets by an operation from the operation unit 22 (step S11). For example, an image including a location where a problem is to be pointed out is designated as a key image from a plurality of images generated by CT.

  Next, in the ICRO terminal 20, query information is input by an operation from the operation unit 22 (step S12). The query information includes the contents of the inquiry (correction instruction), the occurrence type, the affiliation / user of the query issuer, the affiliation / user of the query notification destination, the answer deadline, and the like.

  Further, in the ICRO terminal 20, an annotation is drawn at a location desired to be pointed out in the query on the key image displayed on the display unit 23 by an operation from the operation unit 22 (step S13). As the annotation, an arrow, a mark, a character, a symbol or the like indicating the point to be pointed out is drawn.

  Next, in the ICRO terminal 20, the control unit 21 transmits a query (inquiry) to the clinical trial data management apparatus 10 via the communication unit 24 (step S14). Here, the information transmitted from the ICRO terminal 20 to the clinical trial data management apparatus 10 includes the information indicating the key image specified in step S11, the query information input in step S12, and the annotation drawn in step S13. Information to be shown (shape, drawing position, line type, color, etc.) is included.

In the clinical trial data management apparatus 10, when the communication unit 14 receives a query from the ICRO terminal 20, the control unit 11 associates the received query with the medical image that is the target of the query, and the storage unit 17. (Step S15).
Specifically, the control unit 11 registers the query management information D12 in association with the image management information D7 corresponding to the medical image to be queried based on the query received from the ICRO terminal 20. As the query management information D12, the contents of the inquiry, the generation type, the affiliation / user of the issuer, the affiliation / user of the answering side (notification destination), the answer deadline, etc. are stored in the storage unit 17. Further, the control unit 11 adds the registration date and time of the query to the query management information D12, and the query state included in the query management information D12 is set to “query issue”.

  Further, the control unit 11 adds information indicating the key image to the image management information D7 corresponding to the medical image to be queried. By including information indicating the key image in the image management information D7, the query management information D12 associated with the image management information D7 is associated with the key image.

  Further, information indicating an annotation is registered by the control unit 11 as annotation information D9 in association with VISIT information D6 and image management information D7. Thereby, the information indicating the annotation is associated with the medical image (particularly the key image).

  When a query for a device (modality) is issued, the query management information D12 is registered in association with the device information D4.

  Next, moving to FIG. 8, in the clinical trial data management apparatus 10, the control unit 11 notifies the medical facility terminal 30 of the occurrence of a query via the communication unit 14 (step S16). The occurrence of the query is notified by e-mail, and the URL for logging in to the clinical trial support system is described in this e-mail. Specifically, the control unit 11 reads the mail address corresponding to the notification destination user of the query management information D12 from the user information D3, and transmits the mail to the mail address.

  In the medical facility terminal 30, the occurrence of a query is notified from the clinical trial data management apparatus 10 through the communication unit 34. When an email notifying the occurrence of a query is displayed on the display unit 33 and an operator clicks a URL in the email from the operation unit 32, a login screen provided from the clinical trial data management apparatus 10 is displayed on the display unit. 33. Then, the user ID and password of the operator are input from the operation unit 32, and login to the clinical trial support system is performed (step S17).

In the clinical trial data management apparatus 10, user authentication is performed, and a query reference screen for referring to the query registered in step S15 is provided to the medical facility terminal 30. Specifically, the control unit 11 provides the medical facility terminal 30 with display data including inquiry contents based on the query management information D12 corresponding to the query issued to the operator of the medical facility terminal 30. Is done.
In the medical facility terminal 30, a query reference screen is displayed on the display unit 33 (step S18). Note that, after logging in, instead of transitioning directly to the query reference screen, the operator may designate a transition destination from the main screen.
In the clinical trial data management apparatus 10, the controller 11 changes the query state included in the query management information D12 to “waiting for answer”.

FIG. 9 shows an example of a query reference screen 331 displayed on the display unit 33 of the medical facility terminal 30. The query reference screen 331 includes a first query information display field 331a, a second query information display field 331b, and an answer input field 331c.
The first query information display field 331a displays the query priority, title, issuer affiliation, answerer affiliation, subject ID, and imaging time (VISIT).
In the second query information display column 331b, a query registration date and time, a query text (inquiry content), a sender, and a reference button B1 for displaying an image are displayed.
The answer input field 331c is an area for inputting an answer to the query.

When the operator of the medical facility terminal 30 performs an operation for referring to the medical image to be queried (pressing the reference button B1) from the operation unit 32 on the query reference screen, the image reference for referring to the medical image is performed. A screen is displayed on the display part 33 (step S19). On the image reference screen, a key image is displayed as an initial display, and an annotation is added to the key image and displayed.
Specifically, in the clinical trial data management apparatus 10, the control unit 11 specifies and specifies the medical image to be queried based on the image management information D7 associated with the query management information D12 corresponding to the query reference screen. Display data for displaying the obtained medical image is provided to the medical facility terminal 30. At this time, the control unit 11 specifies the key image based on the information indicating the key image included in the image management information D7, and generates display data for initial display of the key image. In addition, the control unit 11 generates display data in a state where an annotation is added on the key image based on the annotation information D9 associated with the image management information D7.

FIG. 10 shows an example of the image reference screen 332 displayed on the display unit 33 of the medical facility terminal 30. The image reference screen 332 includes image display fields 332a, 332b, and 332c. In the image display fields 332a, 332b, and 332c, medical images associated with the query are displayed. A medical image designated as a key image (medical image displayed in the image display field 332b) is surrounded by a frame C1 and initially displayed so as to be distinguishable from other medical images. Further, on the key image, an annotation A1 drawn on the ICRO terminal 20 indicating the point indicated in the query is drawn.
In FIG. 10, three medical images are displayed at the same time, and the key images therein are displayed so as to be identifiable. Of the plurality of medical images, only the medical images designated as the key images are initially displayed. It may be displayed.

Next, at the medical facility where the clinical trial is being performed, a response (corrective action) to the query is performed (step S20).
For example, when it is determined that the medical image is not suitable for image determination because the contents of the masked item specified in the masking information are not deleted, the medical facility terminal 30 Based on the masking information, personal information included in the accompanying information attached to the target image data is deleted.
If it is determined that the medical image is not suitable for image determination because the imaging condition included in the supplementary information attached to the medical image is different from the imaging condition specified in the clinical trial condition, Re-imaging is performed at the modality 50 of the implementation medical facility.

  In addition, an answer to the query is input from the operation unit 32 by the operator of the medical facility terminal 30 to the answer input field 331c of the query reference screen 331 illustrated in FIG.

  Next, in the medical facility terminal 30, the control unit 31 sends updated information (image data of medical images obtained through correction of supplementary information and re-imaging) and a response to the query via the communication unit 34. It is transmitted to the management apparatus 10 (step S21).

In the clinical trial data management apparatus 10, when the communication unit 14 receives updated information (image data) from the medical facility terminal 30, the control unit 11 stores the received medical image image data in the storage unit 17. The data is registered as data D8, and the query management information D12 is updated (step S22). Here, the controller 11 changes the query state included in the query management information D12 to “answered”.
This completes the query registration process.

  Thereafter, when the ICRO terminal 20 performs QC again and confirms that the problem pointed out by the query has been solved, the clinical trial data management apparatus 10 causes the control unit 11 to execute the query included in the query management information D12. The status is changed to “query complete”.

  FIG. 11 is a ladder chart showing a query progress confirmation process executed by the clinical trial data management apparatus 10 and the pharmaceutical company terminal 60. 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 pharmaceutical company terminal 60 is a program stored in the control unit 61 and the ROM 65. It is realized by software processing in cooperation with.

First, in the pharmaceutical company terminal 60, a login screen provided from the clinical trial data management apparatus 10 is displayed on the display unit 63, and the user ID and password of the operator are input from the operation unit 62 to log in to the clinical trial support system. (Step S31).
In the clinical trial data management apparatus 10, user authentication is performed, and display data for displaying the main screen on the pharmaceutical company terminal 60 is provided.

Next, in the pharmaceutical company terminal 60, when “query search” is designated from the main screen displayed on the display unit 63 by an operation from the operation unit 62, a query search screen is displayed on the display unit 63 ( Step S32).
When a search condition is input from the operation unit 62 on the query search screen, a query list reference screen is displayed on the display unit 63 (step S33). The query list reference screen includes a list of queries that match the search conditions. For example, when a project, a medical facility, a subject, or the like is specified as a search condition, in the clinical trial data management apparatus 10, a query that matches the search condition is extracted by the control unit 11, and a list of extracted queries is displayed. Display data is provided to the pharmaceutical company terminal 60.

Next, in the pharmaceutical company terminal 60, a query whose progress is to be confirmed is designated by an operation from the operation unit 62 on the query list reference screen (step S34).
In the clinical trial data management apparatus 10, the control unit 11 acquires the query state from the query management information D12 corresponding to the designated query. And a query state is transmitted with respect to the pharmaceutical company terminal 60 via the communication part 14 (step S35).
In the pharmaceutical company terminal 60, the query state is displayed on the display unit 63 (step S36), and the progress of the query can be confirmed.
This completes the query progress confirmation process.

  FIG. 12 is a ladder chart showing query totalization processing executed by the clinical trial data management apparatus 10 and the ICRO terminal 20. The processing in the clinical trial data management apparatus 10 is realized by software processing in cooperation with the control unit 11 and the program stored in the ROM 15, and the processing in the ICRO terminal 20 is performed by the control unit 21 and the program stored in the ROM 25. It is realized by software processing by collaboration.

First, in the ICRO terminal 20, a login screen provided from the clinical trial data management apparatus 10 is displayed on the display unit 23, and the user ID and password of the operator are input from the operation unit 22 to log in to the clinical trial support system. (Step S41).
In the clinical trial data management apparatus 10, user authentication is performed, and display data for displaying the main screen on the ICRO terminal 20 is provided.

Next, in the ICRO terminal 20, when “search query” is specified from the main screen displayed on the display unit 23 by an operation from the operation unit 22, a query search screen is displayed on the display unit 23 (step S 30). S42).
When query aggregation is designated by an operation from the operation unit 22 on the query search screen, the query aggregation screen is displayed on the display unit 23 (step S43).

FIG. 13 shows an example of a query tabulation screen 231 displayed on the display unit 23 of the ICRO terminal 20. The query total screen 231 includes a medical facility unit button B11, a user unit button B12, a total period designation field 231a, an occurrence type designation field 231b, and a total result display field 231c.
The medical facility unit button B11 is a button for counting queries for each medical facility to which a medical image is transmitted.
The user unit button B12 is a button for tabulating queries for each user who is an operator of the medical facility terminal 30 when a medical image is transmitted.
The aggregation period designation field 231a is an area for designating the aggregation period of the query to be aggregated. Only queries whose query registration date / time is within the period specified here are subject to aggregation.
The generation type designation field 231b is an area for designating the generation type of a query to be aggregated. As the generation type, “facility”, “subject”, “case image”, “modality”, or the like is designated. In addition, “all” may be specified in order to collect all occurrence types.
The aggregation result display field 231c is an area where the aggregation result is displayed.

Next, in the ICRO terminal 20, a medical facility unit or a user unit is designated as a query total unit by an operation from the operation unit 22 on the query total screen (step S44). Specifically, the medical facility unit button B11 or the user unit button B12 on the query totaling screen 231 is pressed.
In the clinical trial data management apparatus 10, the control unit 11 acquires information indicating the aggregation unit of the query specified in the ICRO terminal 20 via the communication unit 14.

Next, the ICRO terminal 20 designates a totaling period in query totaling by an operation from the operation unit 22 (step S45). Specifically, the start date and end date of the total period are specified in the total period designation field 231a of the query total screen 231.
In the clinical trial data management apparatus 10, the control unit 11 acquires information indicating the query aggregation period specified in the ICRO terminal 20 via the communication unit 14.

Next, in the ICRO terminal 20, the generation type in the query aggregation is designated by the operation from the operation unit 22 (step S46). Specifically, the generation type of the query to be aggregated is designated in the generation type designation field 231b of the query aggregation screen 231.
In the clinical trial data management apparatus 10, the control unit 11 acquires information indicating the generation type of the query specified in the ICRO terminal 20 via the communication unit 14.

In the clinical trial data management apparatus 10, the control unit 11 aggregates the queries based on the query aggregation unit, the aggregation period, and the occurrence type specified in the ICRO terminal 20 (step S47).
When “medical facility unit” is designated as the aggregation unit, the control unit 11 designates the registration date and time within the aggregation period designated by the query management information D12 stored in the storage unit 17 The generated occurrence type queries are extracted and aggregated for each medical facility to which the query is notified.
When “user unit” is designated as the aggregation unit, the control unit 11 designates the registration date and time within the specified aggregation period from the query management information D12 stored in the storage unit 17. Queries of the generated occurrence types are extracted and aggregated for each query destination user.

Next, the totaling result of the query is transmitted from the control unit 11 to the ICRO terminal 20 via the communication unit 14 (step S48).
The ICRO terminal 20 displays the query total result on the display unit 23 (step S49).
This completes the query tabulation process.

In the query totaling screen 231 shown in FIG. 13, since the medical facility unit button B11 is pressed, the totaling result display field 231c displays the results totaled for each medical facility. For each medical facility, the number of subjects, the number of VISITs, the number of queries generated, and the rate of occurrence are displayed.
The number of subjects is the number of subjects in the medical facility. Specifically, it is the number of subjects who have taken images within a specified period in each medical facility.
The number of VISITs is the number of VISITs for all subjects included in a designated period in each medical facility. For example, if there are 10 subjects and there are 10 VISITs for each subject, the number of VISITs is 100.
The number of query occurrences is the total number of query occurrences registered within a period specified for each medical facility.
The occurrence rate is the ratio (%) of the number of query occurrences to the number of VISITs.

As described above, according to the present embodiment, the clinical trial data management apparatus 10 stores the medical image transmitted from the medical facility terminal 30 and the query received from the ICRO terminal 20 in association with each other. It is possible to facilitate the management of queries for images taken in.
In addition, since the clinical trial data management apparatus 10 provides a query to the medical facility terminal 30 and a medical image associated with the query, the medical facility terminal 30 provides the medical image associated with the query. Can be easily referred to.

In addition, when providing a medical image from the clinical trial data management apparatus 10 to the medical facility terminal 30, the key image is initially displayed. Therefore, the medical facility terminal 30 can easily recognize the key image designated on the ICRO terminal 20. Can do.
In addition, when providing a medical image from the clinical trial data management apparatus 10 to the medical facility terminal 30, an annotation is added to the medical image (key image) and displayed, so the medical facility terminal 30 confirms the point indicated in the query. Easy to do.

In addition, by collecting the queries accumulated in the clinical trial data management apparatus 10, it is possible to identify medical facilities and users who frequently generate queries and call attention.
Also, by specifying the period and totaling the queries, the queries can be totaled only for a predetermined period.
In addition, since the queries can be aggregated for each query generation type, it is easy to recognize the cause of the query.

  The description in the above embodiment is an example of the query management 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 14 Communication part 17 Memory | storage part 20 ICRO terminal 30 Medical facility terminal 60 Pharmaceutical company terminal 70 Determination medical terminal 100 Clinical trial system 231 Query totaling screen 331 Query reference screen 332 Image reference screen B1 Reference button B11 Medical facility Unit button B12 User unit button D1 Project information D2 Facility information D3 User information D4 Device information D5 Subject information D6 VISIT information D7 Image management information D8 Image data D9 Annotation information D10 Progress management information D11 QC management information D12 Query management information N1 Communication network

Claims (10)

A clinical trial data management device connected to a first terminal installed in a medical facility that conducts a clinical trial for a new drug and a second terminal installed in a contracted clinical trial institution through a network. And
Image registration means for receiving a medical image related to a clinical trial transmitted from the first terminal, and storing the received medical image in a storage means;
Image providing means for providing a medical image stored in the storage means to the second terminal;
Query registration means for receiving a query for a medical image provided to the second terminal from the second terminal, and storing the received query in the storage means in association with the medical image;
Query providing means for providing a query stored in the storage means to the first terminal and providing a medical image associated with the query to the first terminal;
A clinical trial data management device comprising: The information indicating the annotation drawn at the point indicated in the query for the medical image on the medical image provided from the second terminal to the second terminal is received, and the information indicating the received annotation is associated with the medical image. Annotation registration means for storing in the storage means,
2. The clinical trial data management apparatus according to claim 1, wherein the query providing unit adds the annotation to the medical image and provides the medical image associated with the query to the first terminal. 3. When there are a plurality of medical images corresponding to the query, the query registration unit receives information indicating a key image designated from a plurality of medical images provided to the second terminal from the second terminal, and receives the received key Information indicating an image is stored in the storage means in association with the query;
The clinical trial data management apparatus according to claim 1, wherein the query providing unit initially displays the key image when providing a plurality of medical images associated with the query to the first terminal.   The clinical trial data management apparatus according to any one of claims 1 to 3, further comprising a totaling unit that totalizes the queries stored in the storage unit.   5. The clinical trial data management apparatus according to claim 4, wherein the totaling unit totalizes queries in units of medical facilities to which the medical images are transmitted or in units of operators of the first terminal when the medical images are transmitted. .   6. The clinical trial data management apparatus according to claim 4, wherein the counting means totals only queries within a specified period of time and date stored in the storage means.   The clinical trial data management apparatus according to any one of claims 4 to 6, wherein the tabulating unit tabulates a query for each type of occurrence of the query. The first terminal installed in the medical facility that conducts clinical trials for new drugs, the second terminal installed in the contract clinical trial organization, and the clinical trial data management device are connected via a network so that data communication is possible. Query management system,
The first terminal includes image transmission means for transmitting a medical image related to a clinical trial to the clinical trial data management apparatus,
The clinical trial data management apparatus includes: an image registration unit that stores a medical image received from the first terminal in a storage unit; and an image provision unit that provides the second terminal with the medical image stored in the storage unit. Prepared,
The second terminal includes query transmission means for transmitting a query for a medical image provided from the clinical trial data management apparatus to the clinical trial data management apparatus,
The clinical trial data management apparatus includes a query registration unit that stores the query received from the second terminal in the storage unit in association with the medical image provided to the second terminal, and the query stored in the storage unit. A query management system comprising: query providing means for providing the first terminal with a medical image associated with the query while providing the medical image to the first terminal. The second terminal includes a display unit that displays a medical image provided from the clinical trial data management device, and a drawing unit that draws an annotation at a point indicated in a query for the medical image on the medical image displayed on the display unit. And annotation transmission means for transmitting information indicating the drawn annotation to the clinical trial data management apparatus,
The clinical trial data management apparatus includes an annotation registration unit that stores information indicating the annotation received from the second terminal in the storage unit in association with the medical image provided to the second terminal,
9. The query management system according to claim 8, wherein the query providing means provides the medical image associated with the query by adding the annotation to the medical image when providing the medical image to the first terminal. When there are a plurality of medical images corresponding to the query, the second terminal transmits a designation means for designating a key image from the plurality of medical images and information indicating the designated key image to the clinical trial data management apparatus. And a key image transmission means for
The query registration unit stores information indicating the key image received from the second terminal in the storage unit in association with the query,
The query management system according to claim 8 or 9, wherein the query providing unit initially displays the key image when providing the first terminal with a plurality of medical images associated with the query.

Images