JP2016081474A - Clinical test viewer system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a clinical test viewer system, proposed in order to solve the conventional problem, which does not require for a CRC to input to an EDC system while watching raw data at a medical site, does not require visiting a medical institution to confirm a medical record and do work, helps to greatly save on movement cost and time and fully guarantee authenticity, and which is free of input mistake, eliminates the possibility of a pharmaceutical company developing a drug using erroneous data, and does not finally incur considerable losses.SOLUTION: The clinical test viewer system according to the prevent invention, with some work of clinical test computerized and some work guaranteed of authenticity, has a communication line network capable of transmitting/receiving to and from an information terminal fitted with a photographing function and a cloud server that receives photographic information, and is provided with a photographer specifying means, a photographed date/time specifying means, a photographed place specification means, and an authenticity guaranteeing means by which the authenticity of the photographic information is guaranteed.SELECTED DRAWING: Figure 1

Description

In the present invention, a “medicine candidate” is used as a “medicine” and a clinical trial of “medicine” that collects results for obtaining national approval as a “medicine”, that is, a part of the “clinical trial” is computerized. The present invention relates to a clinical trial viewer system.

Effective for the treatment of human diseases from chemical compounds, substances discovered from plants, fungi in soil, marine organisms, or in experiments or animal experiments in test tubes. Even those that are predicted to be safe are selected as “medicine candidates”.
In the final stage of development of this “medicine candidate”, it is essential to examine the effects and safety of humans through the cooperation of healthy people and patients.
The results obtained in this way will be reviewed by the national government, and those that are approved for use in the treatment of illness and that can be used safely will eventually be adopted as “medicine”.

  Here, human trials are generally referred to as “clinical trials”, but clinical trials that collect results for obtaining national approval using “medicine candidates” are particularly called “clinical trials”. Before clinical trials, animal tests, scientific tests, and safety tests for toxic substances are completed, and human tests are conducted. A national license is also required for conducting the trial, and the trial is conducted in phases 1 to 3.

Phase 1 study (Phase 1)
For healthy adults who volunteered based on voluntary willingness, gradually increase the dose of the study drug from a small amount, and examine the pharmacokinetics (absorption, distribution, metabolism, excretion) and safety (adverse events, side effects) of the study drug This is an exploratory test with the main purpose.

  This is the first step to apply the results of animal experiments to humans, and is an important process for considering safety. However, if surgery or a long-term follow-up is required, or if anti-cancer drugs are expected to cause side effects in advance, patients who have been treated surgically (superficially) May be tested as adjuvant chemotherapy. In the case of anticancer drug testing, it is also important to examine the limits of the dosage and dosage used in the next phase.

Phase 2 study (Phase 2)
The Phase 2 study is a study that examines efficacy, safety, pharmacokinetics, etc. in a relatively small number of patients based on the results of Phase 1. In many cases, the main purpose is to examine the dosage and administration, but gradually increase the dose while confirming the efficacy and safety, or set 3 or more dose groups including the placebo group. Various study designs are employed depending on the dose response and the purpose of the study.

  Since it often has both the purpose of search and verification, it may be divided into an exploratory first phase and a verifiable second phase. In addition, there is a test design that is continuous with the first phase as the second phase and a test design that transitions to the first phase as the second phase. In addition, for highly toxic anticancer agents, the effectiveness may be verified using an index that can be evaluated in a short period of time, such as a tumor reduction effect, in the second phase, and an application for approval may be made.

Phase 3 study (Phase 3)
Phase 3 is performed on a larger scale for patients who will actually use the compound, mainly for efficacy verification and safety studies. Since the main purpose is to prove the effectiveness studied so far, trial designs such as randomization are often adopted. Since it may be several hundred or more cases, it is often performed jointly by multiple facilities. In the case of anticancer agents, it is often performed after manufacture and sale.

Application for manufacturing / marketing approval The test results from Phase 1 to Phase 3 are compiled and a manufacturing / marketing approval application for a pharmaceutical product is made. Once approved by a regulatory authority (Pharmaceuticals and Medical Devices Agency), the product can be sold as a pharmaceutical product.

(Clinical trial flow)
Here, the flow of the clinical trial will be schematically described. To conduct a clinical trial, a pharmaceutical manufacturer conducts an animal test and then submits an application to the country for a new drug test. If permission is obtained for the application, a system for conducting the test is prepared.
Basically, a pharmaceutical manufacturer and a medical institution (hospital / clinic) that conducts clinical trials directly make a contract.

However, in order to conduct a clinical trial, clinical trial design, selection of medical institutions, negotiations, gathering clinical trial participants, starting the trial, and explaining (informed consent), health checkups, examinations, examinations to the subjects. Repeated many times during the trial period.
In addition, it is necessary to establish and hold a clinical trial ethics committee to review clinical trials in order to collect and analyze clinical data conducted in clinical trials from each medical institution and to conduct clinical trials appropriately.

  It is cumbersome for hospitals and clinics to carry out these procedures, staff are required, and measures that do not affect normal medical care are also required. In this way, in order to carry out the test reliably and support medical institutions, the clinical trials are commissioned from the manufacturer (pharmaceutical company) to the test company. This company is called CRO (Development Contracting Organization).

(CRO: Contract Research Organization)
A CRO is an organization (usually a company) that represents and supports all or part of various activities related to clinical trials conducted by pharmaceutical manufacturers in drug development. In other words, it can be said to be an outsourcing company for pharmaceutical development.

  From the viewpoint of GCP (Good Clinical Practice, which means “standards for conducting clinical trials of pharmaceutical products” in Japanese, that is, the standards to be observed when conducting clinical trials) It can also be called a company that supports business.

Here, CRO contracts with pharmaceutical manufacturers, etc. (1) Monitoring (visiting, negotiation) work for clinical trials conducted in medical institutions all over Japan, (2) Data that digitizes collected case report data Management work, (3) Statistical analysis work to statistically verify the effects of investigational drugs.
In this way, the CRO plays the role of a total responsibility manager for clinical trials, but in reality, the SMO CRC is sent to a medical institution to carry out the above work.

Here, CRC is an abbreviation for Clinical Research Coordinator and is also called a clinical trial coordinator.
The CRC conducts all clinical trials at medical institutions, under the direction of the investigator / participating physician, work that does not involve medical judgment, administrative work related to clinical trials, coordination within the team that performs the work, etc. to support. This CRC has also been established as a staff member of SMO, a company that conducts business at the request of CRO.

The role of CRC
CRC's work is diverse and varies depending on the medical institution and clinical trial, but generally performs the following work.

1. Preparation of clinical trial workflow before start of clinical trial
・ Creation of materials for case management
・ Communication / coordination with training / clinical trial related departments
2. Subject response / assistant explanation / subject eligibility confirmation
・ Consultation desk for subjects ・ Emergency response desk ・ Diagnosis ・ Test attendance ・ Subject schedule management ・ Confirmation of medication status (collection and return of remaining medicines)
・ Support for concomitant medications, confirmation of adverse events, compliance confirmation, and non-insurance concomitant medical treatment claims 3. Assistance with clinical trial doctors ・ Assistance for consent explanation ・ Assistance for preparation of consent manual ・ Assistance for screening work ・ Assistance for compliance with clinical trial plan ・ Assistance for preparation of case report ・ Assistance for subject eligibility investigation ・ Support for adverse events ・ Safety 3. Confirmation assistance regarding sex Contact / coordination with clinical trial-related departments, holding co-operator meetings, holding briefing sessions for each department, pharmacy (Study drug outline, ordering work)
・ Assistance of inspection department, nursing department, medical department, investigational drug import, collection Response to client, medical institution, investigational investigator eligibility survey, reporting / monitoring of clinical trial status, monitoring, SDV, response at auditing, case report feedback, direct access, manufacturer auditing, on-site investigation Correspondence of

  Here, CRC is a complicated task and is carried out by sharing work to support medical institutions, but depending on the work, SMO (Site Management Organization Support Organization) that actually supports medical institutions is actually a medical institution. We conduct clinical trials by dispatching staff to medical institutions.

This SMO (Site Management Organization) is a contract with a clinical trial facility (medical institution) and is an organization that supports complicated clinical trials at medical institutions so that appropriate and smooth clinical trials can be conducted based on GCP. It is established.
The purpose of this study is to reduce the burden on staff by supporting the work of doctors, nurses, and the secretariat involved in clinical trials, and to improve the quality and speed of clinical trials.

  Conventionally, CRCs dispatched from the SMO have entered numerical values and the like into software (EDC system) designated by a pharmaceutical company while looking at the original data (medical record) in a medical field, for example, a hospital. In other words, when entering numbers into the EDC system (system for inputting clinical trial results), the CRC always goes to a medical institution and can only be entered inside.

  The reason is that it is considered that the authenticity cannot be maintained unless it is input while looking at the original document (medical record) under guidance from a pharmaceutical company. Therefore, in principle, it was forbidden to take the chart copy home and see it.

  In this way, every time a medical record was confirmed, a visit to a medical institution had to be performed, and the burden of travel costs and time was heavier than expected.

  Furthermore, there were some cases where medical institutions gave up clinical trials with no EDC system, and cases where cooperating medical institutions could not do it because the costs were not met at remote locations.

  In addition, there may be an input error in the input work, and if there is an input error, the pharmaceutical company will develop a drug with the data with the input error, resulting in a huge loss in the end. It could also be a thing.

  Here, a system for extracting trial candidates by computer (Japanese Patent Laid-Open No. 2014-194595) has been proposed in the past, but a system for performing a part of the clinical trial by computerization has not been proposed at all. Was the actual situation.

  By the way, 70% of clinical trial institutions conduct clinical trials using paper charts. Conventionally, there is only a scanning method to convert the paper chart into data, and the work time and labor are enormous.

  On the other hand, when an electronic medical record system is introduced, the original is in the equipment of the doctor in charge. For example, when a medical record is requested in medical trials, the original form is similar to the image of a paper medical record. It was to be printed and presented.

In the present invention, in the case of an electronic medical record, the electronic medical record displayed on the screen can be photographed, or the printed material can be photographed and converted into data.

JP 2014-194595 A

Thus, the present invention was devised to solve the above-described conventional problems, and CRC went to a medical site, for example, a medical institution, while looking at original documents (such as a clinical record of an investigator) in the hospital, There is no need to enter numerical values etc. into the software (EDC system) specified by the pharmaceutical company, so there is no need to visit a medical institution and work every time for medical chart confirmation, saving travel costs and time significantly. The medical institution does not have to give up the trial because there is no place to input with the EDC system, and the cooperating medical institution cannot conduct the trial at a remote location because the cost does not match, and Its authenticity can be sufficiently secured, input errors do not occur, pharmaceutical companies do not develop drugs with incorrect data, and ultimately there is a huge loss It is an object to provide a yarn trials viewer system.

The clinical trial viewer system according to the present invention comprises:
A clinical trial viewer system in which a part of the trial work is computerized and the authenticity of the computerized partial work is ensured,
An information terminal with a photographing function having a position information acquisition function for photographing a clinical trial original document at a hospital or clinic where the clinical trial is performed,
A cloud server for receiving shooting information taken by an information terminal with a shooting function having the position information acquisition function;
An information terminal with a photographing function having the position information acquisition function and a communication network that can be transmitted and received by a cloud server;
The information terminal with a photographing function having the position information acquisition function includes a photographer identifying means for identifying the photographer, a photographing date and time identifying means for identifying a photographing date and time, and a photographing place for identifying a photographing location. An identification means, and an authenticity guarantee means that guarantees the authenticity of the photographed shooting information,
It is characterized by
Or
The photographer specifying means has a log-in function of an information terminal with a photographing function having the position information acquisition function by fingerprint authentication and / or vein authentication to identify the photographer.
It is characterized by
Or
The photographing date and time specifying means has a configuration that can synchronize time during transmission and reception between the information terminal with a photographing function having the position information acquisition function and the cloud server, and can add photographing time to the photographing information to be transmitted. ,
It is characterized by
Or
The shooting location specifying means has a configuration for adding latitude and longitude information of an information terminal with a shooting function having the position information acquisition function to shooting information.
It is characterized by
Or
The authenticity guarantee means has a configuration in which an electronic signature and / or a time stamp is applied to shooting information at the time of shooting,
It is characterized by
Or
The authenticity guarantee means has a configuration in which an electronic signature and / or a time stamp is applied to the shooting information even on the cloud server where the shooting information is received.
It is characterized by
Or
The information terminal with a photographing function having the position information acquisition function includes an operation information recording unit, and the operation information recording unit allows the operation information to be electronically notarized as a log file, and when, who, in which place, which Can be used to support the operation
It is characterized by this.

If it is a clinical trial viewer system according to the present invention,
CRC does not need to enter numerical values into the software (EDC system) specified by the pharmaceutical company while going to a medical site, for example, a medical institution and looking at the original data (medical record) in the hospital. There is no need to visit a medical institution each time, work can be saved, travel costs and time can be greatly saved, and the EDC system needs to give up the clinical trial because there is no place to enter. In addition, there is no need for cooperative medical institutions to conduct clinical trials at remote locations because the costs do not match, and the authenticity can be sufficiently secured, and there are no input mistakes. There is an excellent effect that there is no drug development, and there is no huge loss in the end.

It is schematic structure explanatory drawing which shows the flow of a clinical trial. It is schematic structure explanatory drawing (1) of this invention. It is a schematic explanatory drawing (1) of operation by this invention. It is a schematic explanatory drawing (2) of operation by this invention. It is a schematic explanatory drawing (3) of operation by this invention. It is a schematic structure explanatory drawing (2) of this invention.

Hereinafter, the present invention will be described based on embodiments shown in the drawings.
FIG. 1 is an explanatory diagram of a schematic configuration for explaining a schematic configuration of clinical trial work. The medical institution 3 conducting the clinical trial with the pharmaceutical company 7 concludes a clinical trial implementation contract, and the clinical trial is conducted.

SMO 5 dispatches CRC 8 to the medical institution 3 to assist in the clinical trial. However, as described above, the conventional clinical trial work has many problems.
In other words, CRC8 goes to a medical site, for example, medical institution 3, and inputs numerical values etc. into the computer using software (EDC system) designated by pharmaceutical company 7 while looking at original document (medical record) 2 in the hospital. However, it is necessary to prepare data, and in order to confirm the progress of the clinical trial, it is necessary to visit the medical institution 3 each time to confirm the medical chart and to perform the input operation. Therefore, the movement cost and work time of the CRC staff have been extremely large.

  The medical institution 3 may give up the clinical trial because there is no place to input using the EDC system. Furthermore, since the cooperative medical institution 3 is a remote site, the clinical trial is abandoned because the costs are not suitable. There was also.

  Furthermore, its authenticity cannot be sufficiently secured, and there is a possibility that it may be urgent because of the limited time during the EDC input work described above. There were also concerns that Company 7 could eventually cause enormous losses if it developed drugs with incorrect data.

  Therefore, the present invention has solved these problems all at once.

FIG. 2 shows a schematic configuration diagram of the present invention.
In FIG. 2, reference numeral 1 denotes an information terminal with an imaging function having a position information acquisition function operated in a clinical trial institution 3 such as a hospital or clinic where a clinical trial is performed.

  In the information terminal 1 with a photographing function having the position information acquisition function, the original document 2 of the subject under study, that is, an electronic medical record, a paper medical record, a test result table, an inquiry, a management sheet, a prescription, and patient information A miscellaneous document such as a document is photographed. In the information terminal with a photographing function 1 having the position information acquisition function, it is not necessary to input numerical data such as a medical record. You can just take a picture of your medical records. In addition, the operation procedure is extremely simple, and anyone can take photos.

This will be described with reference to FIGS.
In the information terminal 1 with a photographing function having a position information acquisition function, an ID and a password are input to move to a protocol selection screen. Protocols are organized according to the type of “medicine” to be tested, and a desired protocol, that is, the type of “medicine” in which the desired clinical trial is being performed is selected.

Then, the screen moves to the facility / subject selection screen. Therefore, a predetermined subject is selected, and the original material 2 of the desired subject, for example, the contents of the medical chart is photographed.
Thereafter, it is transmitted as shown in FIG. Then, the transmitted photographed photo data of the source material 2 is received by the cloud server 4 via the communication line 9 (see FIG. 2).

  By the way, the following confirmation is taken when taking a picture. That is, identification of the photographer, identification of the shooting date and time, and identification of the shooting location. These specific items are added to the photo data transmission file to make various types of identification.

  Here, the photographer is specified not only by the ID and password shown in FIG. 3 but also by fingerprint authentication and / or vein authentication in the information terminal 1 with a photographing function having a position information acquisition function. On the cloud server 4 side, various fingerprints and veins are stored and stored in advance, and the photographer is identified by collating them.

  Next, the shooting date and time are specified by synchronizing the time between transmission and reception between the information terminal with shooting function 1 having a position information acquisition function and the cloud server 4 and adding the shooting time to the shooting information to be transmitted. It is performed in a configuration that can be added.

Next, although the shooting location is specified, the information terminal 1 with a shooting function has a position information acquisition function, and a location where the information terminal 1 with a shooting function having the position information acquisition function exists, that is, shooting. The latitude and longitude of the place can be recognized instantly.
Therefore, the shooting location is specified by adding the latitude and longitude of the location where the photo was taken to the transmission file.

Next, the original material 2, that is, the security of the authenticity of the photographed photographing information such as the subject's medical record will be described.
At the time of shooting, an electronic signature and / or a time stamp is added to ensure the authenticity of the photographed data.
In other words, after taking a picture, the original document 2 is changed from a genuine paper medium to a genuine electronic medium by electronic notarization (electronic signature and time stamp) without delay in the information terminal 1 with a photographing function having a position information acquisition function. It becomes possible.

  Further, as described above, an electronic signature is applied to a file at the time of shooting, and the electronic signature is similarly applied to the cloud server 4 on the cloud. That is, double authenticity is performed by pressing the time stamp in addition to the electronic signature on the cloud server 4.

  In addition, the meaning of signing both at the medical institution 3 and the cloud server 4 as a photographing location is to check whether or not the photographed medical chart image is missing information in the VPNV (during transmission). Have a purpose. Further, in the clinical trial viewer system of the present invention, the double authenticity guarantee ensures that the photograph data of the original document 2 can be used as an authentic copy of a hospital electronic chart or a paper chart that is the chart of the original document 2. It becomes.

Here, VPN is used in the present invention. Virtual Private Network (VPN) is a technology that privately expands a network across a public network such as the Internet.
With a VPN, computers can send and receive data while benefiting from the functional, security, and administrative policies of the private network as if they were connected to a private network directly connected across the public network.
This is achieved by creating a virtual connection between two sites by using a dedicated connection method and encryption.

In addition, VPNs can also be used by technologies that connect LANs or services of telecommunications carriers using a closed network that shares bandwidth with a large number of subscribers instead of a fixed dedicated communication line (dedicated line). Can be built.
This is especially true for PPVPN (Provider
Sometimes called Provisioned Virtual Private Networks.

  Since the VPN is a so-called dedicated line, it is used for highly confidential communications such as financial institutions and governments. In the present invention, such a VPN is used as the cloud server 4 as the communication network 9.

Next, the electronic signature will be described.
An electronic signature is an electromagnetic signature applied to an electronic document, and it is necessary to satisfy the following two requirements. That is, it was done to indicate the creator of the electronic document. It is possible to confirm that the created electronic document has not been tampered with.

  In other words, the electronic signature is to make up for the shortcomings of the electronic document that makes it difficult to clearly identify the creator and the presence of tampering, and to confirm who created it and whether it has been tampered with. It can be said that. Therefore, if the received electronic document has an electronic signature, it is possible to identify the creator of the electronic document. If an electronic signature has been made, the electronic signature is created after the electronic signature is created. It can be proved that no one including the person has tampered with the electronic document.

  There are three types of digital signature methods: key generation algorithm, signature (generation) algorithm, and verification algorithm.

  The key generation algorithm is an advance preparation algorithm, and a user who wants to sign must perform this algorithm in advance. When a user executes this algorithm, the algorithm outputs the user's public key and private key (called data). In the case of a seal, the secret key corresponds to a real seal, and the public key corresponds to a mount (seal registration certificate) used for seal verification.

  When a user executes a key generation algorithm, a value called a security parameter is input to the algorithm. The security parameter is a measure representing the difficulty of forging the signature text. A random number is also input to the key generation algorithm. Since a different random number is selected every time the key generation algorithm is executed, a different public / private key pair is assigned to each user.

  Each user keeps a secret key (corresponding to a real seal) so that others cannot use it, while releasing a public key (corresponding to a seal certificate) to everyone. Therefore, only the user himself knows (can use) the secret key of the user, whereas all the users can easily know the public key of the user. The public key and the private key are also called a verification key and a signature key, respectively.

  Once prepared in advance, a user can digitally sign an electronic document using a secret key (signature key) any number of times. To sign an electronic signature, first enter a message into the signature generation algorithm. Then, the signature generation algorithm outputs the signer's signature text for the message. The user who created the signature is called the signer of the signature text.

  The signer enters his / her private key along with the message when creating the signature text. Since only the signer himself knows (can use) the signer's private key, no one other than the signer can create the same signature in the same way. This is the basis for identifying the creator of the signed electronic document.

  The signer sends the message and the corresponding signature to another user. The user (verifier) who has received the message and the signature text can verify whether the signature text is correct by inputting them and executing a verification algorithm. At this time, the verifier also inputs the public key (verification key) of the signer (presumed user) to the verification algorithm. (Because the public key is public information, the verifier can know the signer's public key).

  The verification algorithm determines whether or not the signature sentence was really created by the user and outputs the result. When the verification algorithm determines that the signature text is valid, it is said that the verification algorithm has accepted the A signature text or the signature text has passed verification.

  On the other hand, when the verification algorithm determines that the signature text is invalid, it is said that the verification algorithm rejected the A signature text, or “the signature text did not pass verification”.

  When publishing a public key, it is desirable to make it public through a trusted third party. Several methods are known for associating each public key with the owner of the public key, but there are two typical methods as follows.

A trusted third party creates and publishes a table (public key book) that associates each person's ID with the public key.
A trusted third-party organization operates a certificate authority and uses a PKI mechanism to associate each person's ID and public key (seal certificate).

Next, the time stamp will be described.
A time stamp (digital time stamp) is an electronic time certificate that proves that electronic data existed reliably at a certain time. By matching the encryption information described in the time stamp with the original electronic data, it is possible to reliably and easily confirm that the electronic data is the content certified by the time stamp.

  In the present invention, information such as a medical record of a subject is electronically created in the IT era, and information is produced, copied, and stored in various data formats such as images and videos as well as characters.

However, various problems are pointed out in the electronic data related to the clinical trial.
That is, how to determine when it was made, and whether it is not falsified and its authenticity is guaranteed.

  Therefore, cryptographic security techniques such as “electronic signature” and “time stamp (time authentication)” are required to prove the “authentic information that has not been tampered with”. In other words, if a time stamp or the like is obtained, anyone can easily prove whether electronic data is “information that existed or genuine information that has not been tampered with”.

  Furthermore, acquisition of a log related to a series of operations in the information terminal with a photographing function 1 having a position information acquisition function is also performed. All the operation logs performed in the information terminal 1 with the photographing function having the position information acquisition function are electronically notarized as log files, and it is possible to confirm what operation is performed by whom and when. This brings about the deterrent effect which prevents information leakage to the maximum extent.

  As previously mentioned, from the viewpoint of the CRO (pharmaceutical company helper) side, it has been necessary to visit a medical institution each time and check the medical records, which has been costly and time consuming. .

  There were also cases where medical institutions gave up clinical trials because there was no place to input using the EDC system, and cases where cooperating medical institutions could not do it because the costs were not met at remote locations.

However, in the present invention, these problems have been cleared and the acquisition of the investigator has become easier.
In addition, it was possible to unify complicated materials at the trial site.

Although the facility is different depending on the clinical trial, SMO5 staff such as CRC8 is supported at this facility, and documents and clinical trial data are collected and managed.
These operations are currently carried out using medical records and paper media, and SMO5 staff, for example, CRC8, visits medical institutions to respond.

  In the present invention, this can be converted into data, and management materials and medical records can be stored in the cloud server 4.

  The biggest merit of this is that it greatly reduces the work of the SMO 5 staff going to the medical institution 3 and can also greatly reduce time, transportation costs, and labor costs. In addition to eliminating the chronic shortage of staff at SMO5, the staff is released to some extent from time constraints.

  Furthermore, the staff originally collected the original document 2 from the medical institution 3 and arranged and submitted it to the CRO 6, but the original document 2 is transmitted from the medical institution 3 to the cloud server as photo data in real time. Therefore, monitoring at the CRO terminal 11 has become possible in real time. This makes the test smoother, reduces test costs, and greatly speeds up the entire trial.

  In recent years, the government has promoted shortening the period of approval for new drugs. Therefore, according to the present invention, a new drug is used for a patient earlier, the disease is improved and treated, and the medical cost is reduced. Furthermore, it can be said that it is a clinical trial viewer system that can make a significant contribution to reducing human burden and development costs by making the flow of clinical trials more accurate, preventing mistakes and tampering.

  By the way, in the clinical trial viewer system according to the present invention, the information terminal with imaging function 1 having a so-called position information acquisition function plays a major role. That is, the original document 2 is photographed by the information terminal 1 with the photographing function having the position information acquisition function in the medical institution 3, the photographed original document 2 is sorted for each predetermined item, and the sorted original document 2 is sorted. Is transmitted to the cloud server 4, and the cloud server 4 receives and stores the photo data.

At this time, in order to prevent falsification of the data of the photographed original document 2, the photograph data of the original document 2 is digitized by electronic authentication and an electronic stamp is pressed.
As a result, the stored data is equivalent to that of the original document 2. The electronic authentication is carried out twice in the transmitted data (medical institution 3) and when it is stored in the cloud server 4, and it is proved that the original document 2 has not been falsified in this situation.

Further, as described above, the photographer, the shooting location (GPS), and the shooting time are added to the data and recorded.
This is a more reliable original document 2 than the current document, and falsification can be prevented completely.

  For example, the photographed data is sorted for each data, and the communication line 9 such as a line of a mobile phone company is used from the information terminal 1 with a shooting function having a position information acquisition function to the cloud server 4 of the mobile phone company. It will be stored.

  Although this line can be a mobile phone high-speed line, there is a very high probability that hacking and the like can be prevented from the general Internet, and a VPN is used as this net line.

  This is because, in order to use the information terminal with a photographing function 1 having a position information acquisition function in the present invention, the information terminal with a camera is empirically effective.

  That is, anyone can easily use it without reading the instruction manual for the first time rather than the image quality, and can secure the authenticity of the medical record as the original document 2.

  Furthermore, CRC (SMO personnel and hospital side) travel cost reductions can be achieved by sharing information in real time, specifying shooting locations, and shooting in cooperation with Medical Institution 2.

  That is, the SMO terminal 10 can receive and browse the photograph data of the original document 2 whose authenticity is ensured via the communication line 9 from the cloud server 4, and the photograph data whose authenticity is ensured. This is because the above-mentioned EDC system can be input while watching.

In this way, in the clinical trial viewer system, medical records at medical institutions 3, examination result tables, medical examinations, management sheets, prescriptions, etc. that occur in clinical trials are transmitted to the cloud server 4 as photo data and stored, and the work of SMO 5 It is a system that smoothes the process (Fig. 6).

1 Information terminal with shooting function with location information acquisition function 2 Original document 3 Medical institution 4 Cloud server 5 SMO
6 CRO
7 Pharmaceutical company 8 CRC
9 Communication line 10 SMO terminal 11 CRO terminal

Claims (7)

A clinical trial viewer system in which a part of the trial work is computerized and the authenticity of the computerized partial work is ensured,
An information terminal with a photographing function having a position information acquisition function for photographing a clinical trial original document at a hospital or clinic where the clinical trial is performed,
A cloud server for receiving shooting information taken by an information terminal with a shooting function having the position information acquisition function;
An information terminal with a photographing function having the position information acquisition function and a communication network that can be transmitted and received by a cloud server;
The information terminal with a photographing function having the position information acquisition function includes a photographer identifying means for identifying the photographer, a photographing date and time identifying means for identifying a photographing date and time, and a photographing place for identifying a photographing location. An identification means, and an authenticity guarantee means that guarantees the authenticity of the photographed shooting information,
This is a clinical trial viewer system.
The photographer specifying means has a log-in function of an information terminal with a photographing function having the position information acquisition function by fingerprint authentication and / or vein authentication to identify the photographer.
The clinical trial viewer system according to claim 1.
The photographing date and time specifying means has a configuration that can synchronize time during transmission and reception between the information terminal with a photographing function having the position information acquisition function and the cloud server, and can add photographing time to the photographing information to be transmitted. ,
The clinical trial viewer system according to claim 1 or 2, wherein the clinical trial viewer system is used.
The shooting location specifying means has a configuration for adding latitude and longitude information of an information terminal with a shooting function having the position information acquisition function to shooting information.
The clinical trial viewer system according to claim 1, 2, or 3.
The authenticity guarantee means has a configuration in which an electronic signature and / or a time stamp is applied to shooting information at the time of shooting,
The clinical trial viewer system according to claim 1, 2, 3, or 4.
The authenticity guarantee means has a configuration in which an electronic signature and / or a time stamp is applied to the shooting information even on the cloud server where the shooting information is received.
The clinical trial viewer system according to claim 5, wherein:
The information terminal with a photographing function having the position information acquisition function includes an operation information recording unit, and the operation information recording unit allows the operation information to be electronically notarized as a log file, and when, who, in which place, which Can be used to support the operation
The clinical trial viewer system according to claim 1, claim 2, claim 3, claim 4, claim 5, or claim 6.

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