JP2017151583A - Image transmission apparatus, image transmission system, and clinical trial data management apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To reduce the load in checking quality of a medical image.SOLUTION: A medical facility terminal acquires registered device unique information from a clinical trial data management apparatus (S11), receives a medical image to be transmitted (S12), and acquires device unique information of an imaging apparatus having captured the medical image, from the medical image (S13). When the medical image is the first image (S14: YES) and the imaging apparatus having captured the medical image has not been registered (S16: NO), a warning is displayed (S17) to prevent the medical image from being transmitted. When the imaging apparatus having captured the medical image has been registered (S16: YES) in S16, device unique information in the first picture is temporarily stored (S18). When the received medical image is the second or subsequent images in S14 (S14: NO), device unique information in the medical image is compared with the device unique information in the first image (S19). When they are different from each other (S20: YES), a warning is displayed (S21) to prevent the medical image from being transmitted.SELECTED DRAWING: Figure 7

Description

  The present invention relates to an image transmission apparatus, an image transmission system, and a clinical trial data management apparatus.

  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 requester (pharmaceutical company), a medical facility (hospital), 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 order to share data between facilities involved in clinical trials, for example, in clinical trial data management systems in which information processing devices in pharmaceutical companies, hospitals, and clinical trial data management centers are connected via a network, clinical trial data input from hospitals is used as clinical trial data. Those managed by a management center and browsing clinical trial data from a pharmaceutical company are used (see Patent Document 1).

In clinical trials using images, it is essential to confirm the quality of the imaging device in advance in order to ensure the quality at the time of image capture. In other words, clinical imaging needs to be performed with an approved imaging device.
On the other hand, in an actual image shooting site, since a general patient other than the test subject is also shot, the subject may be shot by a shooting device that has not been approved by mistake.

  Conventionally, in order to avoid this problem, the ICRO that received the image refers to the tag information attached to the image and confirms whether or not the image was taken with an approved imaging device. Yes.

JP 2007-299150 A

  When checking multiple medical images, when multiple images are sent together, a measure is taken to send only the images taken by the same device, but this rule is not always observed. In some cases, the images received by the ICRO may include images captured by a plurality of imaging devices. For this reason, in ICRO, it is necessary to individually check all the images received together, which is a heavy load for checking the quality of medical images.

  Further, if it is ensured that the medical image is taken by a photographing apparatus that has been approved in advance, the burden on the quality confirmation of the medical image is reduced.

  The present invention has been made in view of the above-described problems in the prior art, and an object of the present invention is to reduce the load in the quality confirmation of medical images.

  In order to solve the above problem, the invention according to claim 1 is an image transmission that is installed in a medical facility that conducts a clinical trial for a new drug and that transmits a medical image related to the clinical trial to a clinical trial data management apparatus via a communication network. An acquisition unit that acquires apparatus-specific information of an imaging apparatus in which a medical image to be transmitted is captured, and the transmission target when the acquired apparatus-specific information satisfies a predetermined condition Deterring means for deterring transmission of medical images.

  According to a second aspect of the present invention, in the image transmission device according to the first aspect, there are a plurality of medical images to be transmitted, a comparison unit that compares device-specific information of the plurality of medical images, and the suppression The unit suppresses transmission of the plurality of medical images when there is device unique information different from one device unique information among the device unique information of the plurality of medical images.

  According to a third aspect of the present invention, in the image transmission device according to the second aspect, a warning is displayed when there is device-specific information different from one device-specific information among the device-specific information of the plurality of medical images. A warning display means is provided.

  According to a fourth aspect of the present invention, in the image transmitting device according to the first aspect, the device-specific information acquired by the acquisition unit and the imaging device in the medical facility are used in advance for the clinical trial. Comparing means for comparing the device-specific information of the registered photographing device is provided, and the suppression means is used when the device-specific information acquired by the acquisition means is different from the device-specific information registered in advance. The transmission of the medical image to be transmitted is suppressed.

  According to a fifth aspect of the present invention, in the image transmission device according to the fourth aspect, a warning is displayed when the device specific information acquired by the acquisition unit is different from the pre-registered device specific information. A warning display means is provided.

  According to a sixth aspect of the present invention, in the image transmission device according to any one of the first to fifth aspects, the device specific information includes a station name, a manufacturer name, a model name, a device serial number, and a software version. One or more pieces of information are included.

  The invention according to claim 7 is the image transmission apparatus according to any one of claims 1 to 6, wherein additional information acquisition means for acquiring additional information attached to the medical image to be transmitted; Confirmation means for confirming whether or not the information necessary for performing the clinical trial determination work is included in the incidental information, and information necessary for performing the clinical trial determination work is included in the incidental information. And a second warning display means for displaying a warning when there is not.

  The invention according to claim 8 is the image transmission apparatus according to claim 7, further comprising registration means for registering an item confirmed by the confirmation means, wherein the confirmation means is configured for the item registered by the registration means. , Confirm.

  The invention according to claim 9 is the image transmission device according to claim 7 or 8, wherein the items confirmed by the confirmation means are a series number, an image number, a slice thickness, a pixel interval, a sex, a date of birth, Inspection date or collection date.

  According to a tenth aspect of the present invention, in the image transmission device according to any one of the first to sixth aspects, an incidental information acquisition unit that acquires incidental information attached to the medical image to be transmitted; Subject information acquisition means for acquiring subject information registered in advance, determination means for determining whether or not a predetermined warning condition is met based on the incidental information and the subject information, and the warning condition And a second warning display means for displaying a warning in the case of falling under the above.

  According to an eleventh aspect of the present invention, in the image transmission device according to the tenth aspect, the determination unit is configured to determine in advance a photographing time included in the incidental information and a medication start time included in the subject information. The medical image to be transmitted is determined whether or not the medical image to be transmitted was captured within the effective period, and the medical image to be transmitted was captured within the effective period If it is determined that the warning condition is not satisfied, it is determined that the warning condition is satisfied.

  According to a twelfth aspect of the present invention, in the image transmission device according to the tenth aspect, the determination means is a clinical trial of a subject corresponding to the medical image to be transmitted based on the supplementary information and the subject information. Is determined to be interrupted, and if it is determined that the subject's clinical trial is interrupted, it is determined that the warning condition is satisfied.

  The invention described in claim 13 is a clinical trial data management apparatus and an image transmission apparatus that is installed in a medical facility that conducts a clinical trial for a new drug and that transmits a medical image related to the clinical trial to the clinical trial data management apparatus via a communication network. And an image transmission system comprising: an acquisition unit configured to acquire device-specific information of an imaging device in which a medical image to be transmitted is captured; and the acquired device-specific information is a predetermined condition. And a deterring unit that deters transmission of the medical image to be transmitted.

  The invention described in claim 14 is a clinical trial data management apparatus for registering a medical image taken at a medical facility that conducts a clinical trial for a new drug, and device-specific information of the imaging apparatus in which the medical image to be registered is taken And a deterring unit for deterring registration of the medical image to be registered when the acquired device-specific information meets a predetermined condition.

  The invention described in claim 15 is the clinical trial data management device according to claim 14, wherein there are a plurality of medical images to be registered, and comprises comparison means for comparing device-specific information of the plurality of medical images, The suppression unit suppresses registration of the plurality of medical images when there is device specific information different from one device specific information among the device specific information of the plurality of medical images.

  According to a sixteenth aspect of the present invention, in the clinical trial data management device according to the fourteenth aspect, the device-specific information acquired by the acquisition unit and the imaging device in the medical facility are used for the clinical trial. Comparing means for comparing the device specific information of the photographing apparatus registered in advance, and the suppression means is different from the device specific information acquired by the acquisition means and the device specific information registered in advance In addition, registration of the medical image to be registered is suppressed.

  According to the present invention, it is possible to reduce a load in quality confirmation of a medical image.

It is a system configuration figure of a clinical trial system in a 1st embodiment of the present invention. It is a block diagram which shows the functional structure of a clinical trial data management apparatus. It is a figure which shows a data model example. It is a block diagram which shows the functional structure of a medical facility terminal. It is a flowchart which shows the apparatus registration process performed with a medical facility terminal. It is an example of a display of a new apparatus registration screen. It is a flowchart which shows the 1st medical image transmission process performed with a medical facility terminal. It is a display example of a transmission screen. It is a flowchart which shows the 2nd medical image transmission process performed by the medical facility terminal in the 2nd Embodiment of this invention. It is a flowchart which shows incidental information check processing. It is a flowchart which shows a test subject information check process. It is a flowchart which shows the medical image registration process performed by the clinical trial data management apparatus in the 3rd Embodiment of this invention.

[First Embodiment]
First, a first embodiment of an image transmission 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.

FIG. 1 shows a system configuration of a clinical trial system 100 as an image transmission system according to the first embodiment.
As shown in FIG. 1, a clinical trial system 100 includes a clinical trial data management apparatus 10 installed in an ICRO (Image Contract Research Organization) and an image installed in a medical facility that conducts a clinical trial for a new drug. A medical facility terminal 20, a PACS 30 and a modality 40 as a transmitting device, a pharmaceutical company terminal 50 installed in a pharmaceutical company, and a determination medical terminal 60 used by a determination doctor who determines the effect and safety of a new drug. It is configured. The clinical trial data management apparatus 10, the medical facility terminal 20, the pharmaceutical company terminal 50, and the judging doctor terminal 60 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 medical facility terminals 20, modalities 40, pharmaceutical company terminals 50, and judgment medical terminals 60 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 20 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 performs quality confirmation (QC) on the image data. 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.

  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 20, the PACS 30, and the modality 40 are configured so as to be capable of 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 20 connected to the external network (communication network N1), the PACS 30 and the modality 40 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 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 a patient's determination target region as a subject, 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 attaches additional information to the 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 determined for each clinical trial and are provided to medical facilities in writing. In the medical facility, an order is registered in the HIS / RIS according to the imaging conditions, and imaging is performed by the modality 40.

  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 clinical trial instructions 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. 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, A media drive 18 and the like are provided, and each unit is connected by a bus 19.

  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 realizes a function as a Web server that provides various Web screens to the Web browser by communicating with the Web browser installed in the medical facility terminal 20, the pharmaceutical company terminal 50, and the judging doctor terminal 60 using the HTTP protocol. A web server program for running the program, 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 stores facility information D1, device information D2, device specific information D3, subject information D4, VISIT information D5, image management information D6, and image data D7.

  FIG. 3 shows an example data model. In FIG. 3, “1” and “N” attached to each information indicate that the correspondence between each information is “1 to 1” and “1 to N (plurality)”.

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

  The device information D2 is information related to an imaging device (modality) that is installed in each medical facility and takes an image. The device information D2 includes the device type, performance (how many slice thicknesses can be imaged in CT, etc.), and the like. The device information D2 is associated with the facility information D1.

  The device unique information D3 is information unique to the photographing device. The device unique information D3 includes a modality, a station name, a manufacturer name, a manufacturer model name, a device manufacturing number (serial number), a software version, and the like. The device specific information D3 is associated with the device information D2.

  The subject information D4 belongs to each medical facility and is information related to the subject to be clinical trial, and is managed by subject ID. The subject information D4 includes a subject ID, a medication start date, and the like. Moreover, age, sex, etc. may be contained in the subject information D4. The subject information D4 is associated with the facility information D1.

  The VISIT information D5 is information indicating a photographing period determined for each subject. The shooting period is a period during which shooting is permitted at each shooting timing. The VISIT information D5 is associated with the subject information D4.

  The image management information D6 is information for managing medical images included in each VISIT. The image management information D6 includes the medical facility / user that transmitted the medical image, the image identification information of the image data D7 included in each VISIT, the storage location, and the like. Image management information D6 is associated with device information D2 and VISIT information D5.

  Image data D7 is image data of a medical image transmitted from a medical facility to each VISIT. The image data D7 is associated with the image management information D6.

  The media drive 18 reads data stored in a medium such as a CD-R or DVD-R and writes data to the medium based on a control signal from the control unit 11.

  The control unit 11 receives the medical image related to the clinical trial transmitted from the medical facility terminal 20 via the communication unit 14 and causes the storage unit 17 to store the received medical image.

  The control unit 11 performs QC determination on the medical image received from the medical facility terminal 20 and stores the determined QC result in the storage unit 17 in association with the medical image to be determined.

FIG. 4 shows a functional configuration of the medical facility terminal 20.
As shown in FIG. 4, the medical facility 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. It 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 communication unit 24 further transmits / receives data to / from an external device connected via the in-facility network N2.

  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. Various programs executed in the medical facility terminal 20 and data necessary for the execution of the programs may be stored in the storage unit 27.

  The storage unit 27 is configured by an HDD, a semiconductor nonvolatile memory, or the like, and stores various data. For example, the storage unit 27 stores clinical trial conditions, masking information, a patient ID / subject ID correspondence table, and the like for each clinical trial.

The masking information includes items masked from the supplementary information of the medical image when the medical image is transmitted from the medical facility terminal 20 to the clinical trial data management apparatus 10 in the corresponding clinical trial.
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 21 controls the communication unit 24 to transmit a medical image related to the clinical trial to the clinical trial data management apparatus 10 via the communication network N1.

The control unit 21 acquires device-specific information of the imaging device (modality 40) on which the medical image to be transmitted is captured. Specifically, the control unit 21 acquires device specific information from the header of an image file of a medical image.
The control unit 21 suppresses transmission of a medical image to be transmitted when the acquired device specific information meets a predetermined condition.

Specifically, the control unit 21 compares device specific information of a plurality of medical images to be transmitted.
The control unit 21 suppresses transmission of the plurality of medical images when there is device unique information different from the one device unique information among the device unique information of the plurality of medical images.
The control unit 21 displays a warning when there is device unique information different from one device unique information among device unique information of a plurality of medical images.

In addition, the control unit 21 compares the acquired device-specific information with the device-specific information of the imaging device registered in advance as the one used for the clinical trial among the imaging devices in the medical facility.
The control unit 21 suppresses transmission of a medical image to be transmitted when the acquired device unique information is different from previously registered device unique information.
The control unit 21 displays a warning when the acquired device unique information is different from the device unique information registered in advance.

  When transmitting the medical image to the clinical trial data management apparatus 10, the control unit 21 determines the patient ID included in the incidental information attached to the medical image based on the subject patient ID-subject ID correspondence table of the clinical trial as a subject. 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.

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 medical facility terminal 20, the pharmaceutical company terminal 50, and the judging doctor terminal 60, a predetermined URL (Uniform Resource Locator) is input from the Web browser, and clinical trial data management is performed. The 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.

  FIG. 5 is a flowchart showing a device registration process executed by the medical facility terminal 20 installed in the medical facility where the clinical trial is performed. This processing is realized by software processing by cooperation between the control unit 21 and the program stored in the ROM 25.

  First, in the medical facility terminal 20, the control unit 21 displays a new device registration screen 231 (see FIG. 6) on the display unit 23 based on the display data provided from the clinical trial data management device 10 (step S1). ).

  FIG. 6 shows an example of a new device registration screen 231 displayed on the display unit 23. The new device registration screen 231 includes a registration modality list display area 71, a device registration button B1, and the like. In the registered modality list display area 71, device information of the imaging device used for the clinical trial is displayed. The device registration button B1 is a button for instructing registration of information on the photographing device.

  Next, device information of the imaging device (modality 40) used for the clinical trial is input by an operation from the operation unit 22 (step S2). The device information includes, for example, type, manufacturer, model, name, photographing facility, operating state, and the like.

  Next, a device evaluation phantom is photographed in the modality 40, and an image for device evaluation is captured from the modality 40 via the communication unit 24 by the control unit 21 of the medical facility terminal 20 (step S3).

  Next, the device specific information is extracted from the device evaluation image by the control unit 21 (step S4). Specifically, the device specific information is acquired from the accompanying information (tag information) attached to the device evaluation image by the control unit 21. For example, the tag number (0008, 0060) has “modality”, the tag number (0008, 1010) has “station name”, the tag number (0008, 0070) has “manufacturer name”, and the tag number (0008, 1090). ) Stores the “manufacturer model name”, the tag number (0018, 1000) stores “device manufacturing number”, and the tag number (0018, 1020) stores “software version”.

Next, when the device registration button B1 on the new device registration screen 231 displayed on the display unit 23 is pressed by an operation from the operation unit 22 (step S5), the control unit 21 inputs the button in step S2. The device information, the device unique information extracted in step S4, and the image data of the device evaluation image captured in step S3 are transmitted to the clinical trial data management device 10 via the communication unit 24 (step S6).
This completes the device registration process.

In the clinical trial data management apparatus 10, the communication unit 14 receives apparatus information, apparatus specific information, and apparatus evaluation image data from the medical facility terminal 20. The image data of the apparatus evaluation image is analyzed by the control unit 11, or the apparatus evaluation image displayed on the display unit 13 is visually determined based on the image data, whereby the photographing apparatus (modality 40). Is available for clinical trials. Further, the control unit 11 determines whether or not the imaging apparatus can be used for the clinical trial based on the apparatus information and the apparatus specific information.
When it is determined that the imaging device can be used for the clinical trial, the device information received from the medical facility terminal 20 by the control unit 11 is the facility information D1 corresponding to the medical facility having the imaging device as the device information D2. It is associated and stored in the storage unit 17. Further, the device specific information received from the medical facility terminal 20 by the control unit 11 is stored in the storage unit 17 as device specific information D3 in association with the device information D2 corresponding to the imaging device.

  In a medical facility where a clinical trial is carried out, when the procedure for subject approval is completed after the device registration process is completed, a captured image of the subject can be transmitted. When a pre-dose image, a post-dose image, and the like are captured, the captured image is transmitted to the clinical trial data management apparatus 10.

  FIG. 7 is a flowchart showing a first medical image transmission process executed by the medical facility terminal 20 installed in the medical facility where the clinical trial is performed. This processing is realized by software processing by cooperation between the control unit 21 and the program stored in the ROM 25.

  First, the registered device-specific information is acquired from the clinical trial data management device 10 by the control unit 21 via the communication unit 24 (step S11). Specifically, in the clinical trial data management apparatus 10, device information D2 associated with the facility information D1 corresponding to the medical facility where the medical facility terminal 20 is installed is specified, and device specific information associated with the device information D2 D3 is specified, and the device specific information D3 is provided to the medical facility terminal 20.

  Next, when a medical image to be transmitted is selected on the transmission screen 232 (see FIG. 8) displayed on the display unit 23 by an operation from the operation unit 22, the selected medical image is selected by the control unit 21. Captured (step S12).

  FIG. 8 shows an example of a transmission screen 232 displayed on the display unit 23. The transmission screen 232 includes a medical image display area 81 and the like. In addition, the image list screen 233 displays a list of medical images captured by various modalities 40 and stored in the PACS 30. One of the medical images included in the image list screen 233 is dragged and dropped onto the medical image display area 81 by an operation from the operation unit 22, so that it is selected as a medical image to be transmitted. The selected medical image is captured from the PACS 30 by the control unit 21 and stored in the RAM 26.

  Next, the control unit 21 acquires device-specific information of the imaging device in which the medical image is captured from the captured medical image (step S13). Specifically, the device specific information is acquired from the accompanying information (tag information) attached to the medical image by the control unit 21.

Next, the control unit 21 determines whether or not the captured medical image is the first image (step S14).
If the captured medical image is the first image (step S14; YES), the device specific information of the medical image is included in the registered device specific information acquired in step S11 by the control unit 21. It is confirmed whether it has been (step S15).

  If the device-specific information of the medical image is not included in the registered device-specific information, that is, if the imaging device that captured the medical image is not registered (step S16; NO), the control unit 21 does not register the device-specific information. A warning that the device is a registered device is displayed on the display unit 23 (step S17). Then, the control unit 21 suppresses transmission of the medical image.

  In step S16, if the device-specific information of the medical image is included in the registered device-specific information, that is, if the imaging device that has captured the medical image has been registered (step S16; YES), the control unit 21. The device-specific information of the captured medical image is temporarily stored in the RAM 26 (step S18).

In step S14, if the captured medical image is not the first image (step S14; NO), that is, if it is the second or subsequent image, the controller 21 controls the captured medical image device. The unique information is compared with the device unique information of the first medical image temporarily stored (step S19).
If the device-specific information of the captured medical image is different from the device-specific information of the first medical image (step S20; NO), the control unit 21 displays a warning indicating that the device is a different device on the display unit 23. (Step S21). For example, a message “Multiple modality images cannot be captured” is displayed on the display unit 23. Then, the control unit 21 suppresses transmission of the medical image.

In step S20, when the device specific information of the captured medical image is the same as the device specific information of the first medical image (step S20; YES), or after step S18, the control unit 21 becomes a transmission target. It is determined whether there is a next image (step S22).
If there is a next image to be transmitted (step S22; YES), the process returns to step S12 and the process is repeated.

In step S22, when there is no next image to be transmitted (step S22; NO), the image data of all the medical images captured so far by the control unit 21 is obtained through the communication unit 24. The data is transmitted to the data management device 10 (step S23).
This completes the first medical image transmission process.

  Prior to the transmission of the image data, the control unit 21 conducts the clinical trial medical treatment included in the incidental information of the image data of the medical image generated by the modality 40 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 20 by the communication unit 14, a QC determination is performed by the control unit 11, and the clinical data is suitable for image determination. The image data of the medical image is registered in the storage unit 17 as image data D7.

  As described above, according to the first embodiment, the medical facility terminal 20 acquires the device-specific information of the imaging device in which the medical image to be transmitted is captured, and the acquired device-specific information is predetermined. When the above condition is satisfied, transmission of a medical image to be transmitted is suppressed, so that it is possible to reduce a load in quality confirmation of the medical image.

  For example, in the medical facility terminal 20, if the device specific information matches a plurality of medical images, transmission to the clinical trial data management device 10 is permitted, and the device specific information is stored for the plurality of medical images. If they are not complete, they are not transmitted to the clinical trial data management apparatus 10. As a result, the clinical trial data management apparatus 10 makes a determination for each image when determining whether or not each medical image is taken by a pre-registered imaging apparatus (an approved imaging apparatus). There is no need.

  In the medical facility terminal 20, when the device unique information acquired from the medical image is different from the device unique information registered in advance, it is not transmitted to the clinical trial data management device 10. It is possible to reduce the load in quality confirmation of medical images.

  In addition, a warning is displayed when device-specific information acquired from medical images differs from pre-registered device-specific information, or when device-specific information is not available for multiple medical images. The operator can be notified that the medical image is not suitable and can be alerted.

  In step S17 and step S21, when a warning is displayed, an instruction as to whether or not to execute transmission of a medical image is accepted, and when the execution of transmission of a medical image is instructed, the medical image is forcibly executed. May be transmitted. For example, when the clinical trial period is long (2 to 3 years), there are cases where the image is taken with an unregistered device when the device is replaced. In that case, the medical image may be transmitted to the clinical trial data management apparatus 10 for the time being, and the apparatus registration may be performed after receiving an indication from the ICRO. In such a situation, it is also effective to permit transmission of a medical image taken by an unregistered device according to the operator's request.

[Second Embodiment]
Next, a second embodiment to which the present invention is applied will be described.
Since the clinical trial system in 2nd Embodiment is the structure similar to the clinical trial system 100 shown in 1st Embodiment, FIGS. 1-4 is used and illustration and description are abbreviate | omitted about the structure. . Hereinafter, a configuration and processing characteristic of the second embodiment will be described.

  In the second embodiment, the medical facility terminal 20 not only checks the imaging apparatus but also checks whether or not the medical image is suitable for image determination regarding other aspects.

The control unit 21 of the medical facility terminal 20 acquires incidental information attached to the medical image to be transmitted. Specifically, the control unit 21 acquires various incidental information from the header of the image file of the medical image.
The control unit 21 confirms whether or not the incidental information includes information necessary for performing the clinical trial determination work. Items to be confirmed here (hereinafter referred to as confirmation items) are registered in advance in the storage unit 27 by operations from the operation unit 22. The control unit 21 confirms the confirmation items registered in advance.
Examples of the confirmation item include a series number, an image number, a slice thickness, a pixel interval, a sex, a date of birth, an inspection date and time, and a collection date and time. The collection date and time is the shooting date and time for each image.
The control unit 21 displays a warning when the incidental information does not include information necessary for performing the clinical trial determination work.

In addition, the control unit 21 acquires subject information registered in advance.
The control unit 21 determines whether or not a predetermined warning condition is satisfied based on the incidental information acquired from the medical image and the subject information.
The control unit 21 displays a warning when the warning condition is met.

  For example, the control unit 21 is based on the imaging time (such as imaging date) included in the supplementary information, the medication start time (such as the medication start date) included in the subject information, and a predetermined imaging period. It is determined whether or not the medical image to be transmitted was taken within the effective period, and if it is determined that the medical image to be transmitted was not taken within the effective period, the warning condition is set. Judge as applicable.

  Based on the incidental information and the subject information, the control unit 21 determines whether or not the subject's clinical trial corresponding to the medical image to be transmitted is interrupted, and determines that the subject's clinical trial is interrupted. In this case, it is determined that the warning condition is met.

FIG. 9 is a flowchart showing a second medical image transmission process executed by the medical facility terminal 20 installed in the medical facility where the clinical trial is performed. This processing is realized by software processing by cooperation between the control unit 21 and the program stored in the ROM 25.
In the second medical image transmission process, the processes in steps S31 to S41 are the same as the processes in steps S11 to S21 in the first medical image transmission process, and thus description thereof is omitted.

  In step S40, when the device specific information of the captured medical image is the same as the device specific information of the first medical image (step S40; YES), or after step S38, the control unit 21 causes the additional information check process. Is performed (step S42).

Here, the incidental information check process will be described with reference to FIG.
Accompanying information is acquired from the captured medical image by the control unit 21 (step S51).

  Next, with respect to the confirmation items stored in the storage unit 27, the control unit 21 confirms whether or not the supplementary information includes information necessary for performing the clinical trial determination work (step S52). Specifically, the control unit 21 includes information such as series number, image number, slice thickness, pixel interval, gender, date of birth, examination date and time, collection date and time, in the supplementary information (tag information) of the medical image. It is confirmed whether or not.

  When the incidental information does not include information necessary for performing the clinical trial determination work (step S52; NO), the control unit 21 does not include information necessary for performing the clinical trial determination work. A warning to that effect is displayed on the display unit 23 (step S53). Then, the control unit 21 suppresses transmission of the medical image.

  In step S52, when the incidental information includes information necessary for performing the clinical trial determination work (step S52; YES), the process returns to FIG. 9 and the subject information check process is performed by the control unit 21. (Step S43).

Here, the subject information check process will be described with reference to FIG.
Accompanying information is acquired from the captured medical image by the control unit 21 (step S61). Specifically, the control unit 21 acquires information such as the imaging date and time and the patient ID from the accompanying information (tag information) attached to the medical image.

Next, subject information is acquired from the clinical trial data management apparatus 10 by the control unit 21 via the communication unit 24 (step S62). Specifically, when the subject ID corresponding to the patient ID included in the supplementary information of the medical image is specified by the control unit 21 from the patient ID-subject ID correspondence table, the clinical trial data management apparatus 10 sets this subject ID. Corresponding subject information D4 is identified and provided to the medical facility terminal 20.
When the patient ID attached to the medical image has already been replaced with the subject ID, subject information D4 corresponding to the subject ID is acquired from the clinical trial data management apparatus 10.

  Next, an imaging period (imaging period defined by the clinical trial protocol) registered in advance from the clinical trial data management apparatus 10 is acquired by the control unit 21 via the communication unit 24 (step S63). Specifically, in the clinical trial data management apparatus 10, the VISIT information D5 associated with the corresponding subject ID is specified, and the imaging period included in the VISIT information D5 is provided to the medical facility terminal 20. The imaging period is determined with a certain range, for example, within 3 days after 4 weeks from the medication start date.

  Next, transmission is performed by the control unit 21 based on the imaging time (imaging date) included in the supplementary information, the medication start time (medication start date) included in the subject information, and the imaging period registered in advance. It is determined whether or not the target medical image is taken within the effective period (step S64).

  When the medical image to be transmitted is not taken within the effective period (step S64; NO), the control unit 21 determines that the warning condition is satisfied, and displays a warning indicating that it is out of the effective period. 23 (step S65). For example, a message “This image is an image that cannot be used for clinical trials because it is outside the valid period” is displayed on the display unit 23. Then, the control unit 21 suppresses transmission of the medical image.

  In step S64, when the medical image to be transmitted is taken within the effective period (step S64; YES), the control unit 21 determines whether or not the subject's clinical trial is interrupted. (Step S66). Information indicating whether or not the subject's clinical trial is interrupted is included in the subject information. Specifically, the subject ID corresponding to the patient ID included in the supplementary information of the medical image is specified by the control unit 21, and the subject information corresponding to the subject ID (subject information acquired in step S62) is referred to. It is determined whether the subject's clinical trial has been interrupted.

  When the subject's clinical trial is interrupted (step S66; YES), the control unit 21 determines that the warning condition is satisfied, and displays a warning indicating that the subject is interrupted on the display unit 23 (step S67). . For example, a message “This will be a subject whose clinical trial has been interrupted” is displayed on the display unit 23. Then, the control unit 21 suppresses transmission of the medical image.

In step S66, when the subject's clinical trial is not interrupted (step S66; NO), the process returns to FIG. 9 and proceeds to step S44. The processing from step S44 to step S45 is the same as the processing from step S22 to step S23 in the first medical image transmission processing, and a description thereof will be omitted.
This completes the second medical image transmission process.

  As described above, according to the second embodiment, in addition to the same effects as those of the first embodiment, it is necessary to acquire incidental information from a medical image and perform clinical trial determination work on the incidental information. Therefore, it is possible to prevent a medical image that is not suitable for the clinical trial from being transmitted to the clinical trial data management apparatus 10.

In clinical trials, the imaging period from the start of medication is clearly determined, and images not captured during this period are invalid. In addition, there is a problem that the subject drops out of the clinical trial if the photographing is not performed within the effective period.
On the other hand, according to the second embodiment, based on the incidental information acquired from the medical image and the subject information, it is determined whether a predetermined warning condition is met, and the warning condition A warning can be displayed when this is true. For example, a warning is displayed when it is determined that the medical image to be transmitted is not taken within the effective period, or when the clinical trial of the subject corresponding to the medical image to be transmitted is interrupted Therefore, it is possible to prevent a medical image not suitable for the clinical trial from being transmitted to the clinical trial data management apparatus 10.

  In step S37, step S41, step S53, step S65, and step S67, when a warning is displayed, an instruction as to whether or not to perform transmission of a medical image is accepted, and execution of medical image transmission is instructed. In such a case, the medical image may be forcibly transmitted.

[Third Embodiment]
Next, a third embodiment to which the present invention is applied will be described.
Since the clinical trial system in 3rd Embodiment is the structure similar to the clinical trial system 100 shown in 1st Embodiment, FIGS. 1-4 is used and illustration and description are abbreviate | omitted about the structure. . Hereinafter, a configuration and processing characteristic of the third embodiment will be described.

  The third embodiment is an example in the case where a medium on which a medical image is recorded in a medical facility is brought into the clinical trial data management apparatus 10.

  The control unit 11 of the clinical trial data management apparatus 10 controls the media drive 18 to capture a medical image taken at a medical facility that conducts a clinical trial for a new drug from the media, and store the captured medical image in the storage unit 17 ( sign up).

The control unit 11 acquires device-specific information of an imaging device that has captured a medical image to be registered. Specifically, the control unit 11 acquires device-specific information from the header of the medical image file.
The control unit 11 suppresses registration of a medical image to be registered when the acquired device unique information meets a predetermined condition.

Specifically, the control unit 11 compares device specific information of a plurality of medical images to be registered.
The control unit 11 suppresses registration of the plurality of medical images when there is device unique information different from the one device unique information among the device unique information of the plurality of medical images.

In addition, the control unit 11 compares the acquired device specific information with the device specific information of the imaging device registered in advance as the one used for the clinical trial among the imaging devices in the medical facility.
The control unit 11 suppresses registration of a medical image to be registered when the acquired device unique information is different from previously registered device unique information.

  FIG. 12 is a flowchart showing a medical image registration process executed by the clinical trial data management apparatus 10. This processing is realized by software processing through cooperation between the control unit 11 and the program stored in the ROM 15.

  First, the registered device unique information is acquired from the storage unit 17 by the control unit 11 (step S71). Specifically, the device information D2 associated with the facility information D1 corresponding to the medical facility where the medical facility terminal 20 is installed is identified, the device specific information D3 associated with the device information D2 is identified, and the device The unique information D3 is acquired.

  Next, when a medical image to be registered is selected on the registration screen displayed on the display unit 13 by an operation from the operation unit 12, the control unit 11 controls the media drive 18 to select the selected medical image. Is captured from the medium (step S72). The medical image captured by the control unit 11 is stored in the RAM 16.

  Next, the control unit 11 acquires device-specific information of the imaging device in which the medical image was captured from the captured medical image (step S73). Specifically, the device specific information is acquired from the accompanying information (tag information) attached to the medical image by the control unit 11.

Next, the control unit 11 determines whether or not the captured medical image is the first image (step S74).
When the captured medical image is the first image (step S74; YES), the control unit 11 includes the device-specific information of the medical image in the registered device-specific information acquired in step S71. It is confirmed whether or not it is (step S75).

  If the device-specific information of the medical image is not included in the registered device-specific information, that is, if the imaging device that has captured the medical image is not registered (step S76; NO), the control unit 11 does not yet register it. A warning that the device is a registered device is displayed on the display unit 13 (step S77). Then, the registration of the medical image is suppressed by the control unit 11.

  In step S76, if the device-specific information of the medical image is included in the registered device-specific information, that is, if the imaging device that captured the medical image has been registered (step S76; YES), the control unit 11, the device-specific information of the captured medical image is temporarily stored in the RAM 16 (step S78).

In step S74, if the captured medical image is not the first image (step S74; NO), that is, if it is the second or subsequent image, the controller 11 controls the captured medical image device. The unique information is compared with the device unique information of the first medical image temporarily stored (step S79).
If the device-specific information of the captured medical image is different from the device-specific information of the first medical image (step S80; NO), the control unit 11 displays a warning that the device is a different device on the display unit 13. (Step S81). Then, the registration of the medical image is suppressed by the control unit 11.

In step S80, when the device-specific information of the captured medical image is the same as the device-specific information of the first medical image (step S80; YES), or after step S78, the control unit 11 becomes a registration target. It is determined whether there is a next image (step S82).
If there is a next image to be registered (step S82; YES), the process returns to step S72 and the process is repeated.

In step S82, if there is no next image to be transmitted (step S82; NO), the image data D7 of all medical images captured so far by the control unit 11 is stored in the storage unit 17. (Step S83).
This completes the medical image registration process.

  As described above, according to the third embodiment, the clinical trial data management apparatus 10 acquires the device-specific information of the imaging device in which the medical image to be registered is acquired, and the acquired device-specific information is When a predetermined condition is met, registration of a medical image to be registered is suppressed, so that it is possible to reduce a load in quality confirmation of the medical image.

  For example, in the clinical trial data management apparatus 10, when the device-specific information matches a plurality of medical images, registration in the storage unit 17 is permitted, and the device-specific information is prepared for the plurality of medical images. If it does not exist, it is not registered in the storage unit 17. Thereby, in the clinical trial data management apparatus 10, it is possible to reduce the load in the quality confirmation of the medical image.

  Further, in the clinical trial data management apparatus 10, when the device specific information acquired from the medical image is different from the device specific information registered in advance, it is not registered in the storage unit 17. It is possible to reduce the load in image quality confirmation.

  In step S77 and step S81, when a warning is displayed, an instruction as to whether or not to execute registration of a medical image is accepted, and when an instruction to execute registration of a medical image is issued, the medical image is forcibly issued. May be registered.

  In the third embodiment, the case where a medical image is delivered from the medical facility to the clinical trial data management apparatus 10 via the media has been described. However, the clinical trial data management apparatus 10 transmits the medical image transmitted from the medical facility terminal 20. The same processing may be performed when an image is received and the received medical image is registered.

  Moreover, the description in each said embodiment is an example of the image transmission apparatus which concerns on this invention, an image transmission system, and a clinical trial data management apparatus, It is not limited to this. The detailed configuration and detailed operation of each part constituting the apparatus can be changed as appropriate without departing from the spirit of the present invention.

  For example, in each of the embodiments described above, the QC determination is performed in the clinical trial data management apparatus 10 that manages information related to the clinical trial. However, the apparatus that manages information related to the clinical trial and the apparatus that performs the QC determination are different. It may be a device.

  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 Storage part 18 Media drive 20 Medical facility terminal 21 Control part 22 Operation part 23 Display part 24 Communication part 27 Storage part 40 Modality 100 Clinical trial system 231 New apparatus registration screen 232 Transmission screen D1 Facility information D2 Device information D3 Device specific information D4 Subject information D5 VISIT information D6 Image management information D7 Image data N1 Communication network N2 Facility network

Claims (16)

An image transmitting apparatus that is installed in a medical facility that conducts a clinical trial for a new drug and transmits a medical image related to the clinical trial to a clinical trial data management apparatus via a communication network,
An acquisition means for acquiring device-specific information of an imaging device in which a medical image to be transmitted is captured;
Deterring means for deterring transmission of the medical image to be transmitted when the acquired device-specific information meets a predetermined condition;
An image transmission apparatus comprising: There are a plurality of medical images to be transmitted,
Comparing means for comparing device-specific information of the plurality of medical images,
The image transmission device according to claim 1, wherein the suppression unit suppresses transmission of the plurality of medical images when there is device unique information different from one device unique information among the device unique information of the plurality of medical images. .   The image transmission device according to claim 2, further comprising: a warning display unit that displays a warning when there is device unique information different from one device unique information among the device unique information of the plurality of medical images. Comparing means for comparing the device-specific information acquired by the acquisition unit with the device-specific information of the imaging device registered in advance as the one used in the clinical trial among the imaging devices in the medical facility,
The image according to claim 1, wherein the suppression unit suppresses transmission of the medical image to be transmitted when the device specific information acquired by the acquisition unit is different from the previously registered device specific information. Transmitter device.   The image transmission device according to claim 4, further comprising: a warning display unit that displays a warning when the device specific information acquired by the acquisition unit is different from the device specific information registered in advance.   The image transmission device according to claim 1, wherein the device-specific information includes one or more pieces of information among a station name, a manufacturer name, a model name, a device manufacturing number, and a software version. Incidental information acquisition means for acquiring incidental information attached to the medical image to be transmitted;
Confirmation means for confirming whether or not the necessary information is included in the incidental information for performing the clinical trial determination work;
A second warning display means for displaying a warning when the incidental information does not include information necessary for performing the clinical trial determination work;
An image transmission apparatus according to any one of claims 1 to 6. Registration means for registering items confirmed by the confirmation means;
The image transmitting apparatus according to claim 7, wherein the confirmation unit confirms the item registered by the registration unit.   The image transmitting apparatus according to claim 7 or 8, wherein the items confirmed by the confirmation unit are a series number, an image number, a slice thickness, a pixel interval, a sex, a date of birth, an inspection date and time, or a collection date and time. Incidental information acquisition means for acquiring incidental information attached to the medical image to be transmitted;
Subject information acquisition means for acquiring subject information registered in advance;
Based on the incidental information and the subject information, determination means for determining whether or not a predetermined warning condition is satisfied,
Second warning display means for displaying a warning when the warning condition is satisfied;
An image transmission apparatus according to any one of claims 1 to 6.   The determination means determines that the medical image to be transmitted is within an effective period based on the imaging time included in the supplementary information, the medication start time included in the subject information, and a predetermined imaging period. 11. The method according to claim 10, wherein it is determined whether the warning condition is satisfied when it is determined whether the medical image to be transmitted is not captured within an effective period. The image transmission device described.   The determination means determines whether or not a subject's clinical trial corresponding to the medical image to be transmitted is interrupted based on the incidental information and the subject information, and the subject's clinical trial is interrupted. The image transmission device according to claim 10, wherein the image transmission device determines that the warning condition is satisfied when it is determined. An image transmission system comprising: a clinical trial data management device; and an image transmission device that is installed in a medical facility that conducts a clinical trial for a new drug and that transmits a medical image related to the clinical trial to the clinical trial data management device via a communication network. ,
The image transmission device includes:
An acquisition means for acquiring device-specific information of an imaging device in which a medical image to be transmitted is captured;
Deterring means for deterring transmission of the medical image to be transmitted when the acquired device-specific information meets a predetermined condition;
An image transmission system comprising: A clinical trial data management device for registering medical images taken at a medical facility that conducts a clinical trial for a new drug,
An acquisition means for acquiring device-specific information of an imaging device in which a medical image to be registered is captured;
Deterring means for deterring registration of the medical image to be registered when the acquired device specific information meets a predetermined condition;
A clinical trial data management device comprising: There are a plurality of medical images to be registered,
Comparing means for comparing device-specific information of the plurality of medical images,
15. The clinical trial data management according to claim 14, wherein the suppression means suppresses registration of the plurality of medical images when there is device specific information different from one device specific information among the device specific information of the plurality of medical images. apparatus. Comparing means for comparing the device-specific information acquired by the acquisition unit with the device-specific information of the imaging device registered in advance as the one used in the clinical trial among the imaging devices in the medical facility,
15. The clinical trial according to claim 14, wherein the suppression unit suppresses registration of the medical image to be registered when the device specific information acquired by the acquisition unit is different from the previously registered device specific information. Data management device.