KR20200067636A - Method for processing and verificating clinical trial data - Google Patents

Abstract

A method for processing and verifying clinical trial data according to one embodiment of the present invention includes the steps of: receiving first clinical trial data of a patient from a hospital terminal; receiving second clinical trial data of the patient from the patient terminal; processing the second clinical trial data into a standard data format; and verifying data by comparing the first clinical trial data and the second clinical trial data, and if the first clinical trial data and the second clinical trial data are identical, the first clinical trial data is converted into final data, and if not identical, notifying an alarm to the hospital terminal.

Description

METHOD FOR PROCESSING AND VERIFICATING CLINICAL TRIAL DATA

The present invention relates to a method for processing and verifying clinical trial data.

As the bio industry expands, clinical trials to develop new drugs are also increasing. Recently, it is becoming more common to manage case report forms (CRF) used for clinical trials rather than paper, and research on how to efficiently and safely manage data used in clinical trials. It is active.

When a patient visits a site for a clinical trial and performs various tests or questionnaires, these test records are first recorded on paper or in a hospital-mandated medical records system (EMR). Subsequently, the clinical research nurse (CRC) of the hospital (site) performs a task of first transferring the generated/recorded source data in the hospital to the electronic case record (eCRF). At this time, since many input errors occur, in most clinical trials, a source data verification (SDV) is separately performed.

Korean Patent Publication No. 10-2018-0081470: Information concealment system using a biometric authentication-based lightweight mutual authentication protocol in a mobile environment, a computer readable recording medium having a method therefor and a program for performing the method

In the case of medical data, since the place having the source data is limited to the hospital, the data verification (SDV) as described above is usually input to the hospital's medical record system and the electronic case record (eCRF). This is done through the process of someone's eye-to-eye comparison of the old data. As a result, data verification (SDV) is time consuming and expensive.

On the other hand, since all hospitals use different data formats, it is difficult to fit the data in a standardized format when performing multicenter clinical trials.

However, the technical problems to be achieved by the embodiments of the present invention are not limited to the problems mentioned above, and various technical problems can be derived within the scope apparent to a person skilled in the art from the contents to be described below.

A method for processing and verifying clinical trial data according to an embodiment of the present invention includes: receiving first clinical trial data of a patient from a hospital terminal; Receiving the second clinical trial data of the patient from the patient's terminal; Processing the second clinical trial data into a standard data format; The first clinical trial data is compared with the second clinical trial data, and if the first clinical trial data and the second clinical trial data match, the first clinical trial data is converted into final data, and the first clinical trial data is compared. And a data verification step of notifying the hospital terminal when the test data and the second clinical trial data do not match.

In an embodiment of the present invention, patients, who can obtain and secure source data by requesting to the hospital without the problem of personal information infringement, participate in the data input/verification process, time, cost, and inconvenience required for data verification Can reduce

Meanwhile, the quality of the clinical trial data can be improved by allowing the patient to know the authenticity of the entered clinical trial data to participate in the data verification (SDV) to verify the clinical trial data.

In addition, the accuracy of data verification is improved by automatically comparing data input to two different locations, rather than visually comparing source data and data input to the electronic case record.

In addition, the data entered by the patient is automatically processed into a standard data format, so that clinical trial data can be easily verified even in the case of clinical trials conducted in multiple centers.

1 is a view showing a system for implementing a clinical trial data processing and verification method according to an embodiment of the present invention.
2 is a flow chart showing a comprehensive process of a clinical trial data processing and verification method according to an embodiment of the present invention.
3 is an example of a medical record copy based on a mobile app.

Advantages and features of the present invention, and how to achieve them will be apparent with reference to the embodiments described below in detail together with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but may be implemented in various forms, 본 only these embodiments allow the disclosure of the present invention to be complete, 　 having ordinary knowledge in the art to which the present invention pertains. It is provided to fully inform the person of the scope of the invention, and the scope of the invention is only defined by the claims.

In describing the embodiments of the present invention, detailed descriptions of known functions or configurations will be omitted except when necessary in describing the embodiments of the present invention. In addition, terms to be described later are terms defined in consideration of functions in an embodiment of the present invention, which may vary according to a user's or operator's intention or practice. Therefore, the definition should be made based on the contents throughout this specification.

The functional blocks shown in the drawings and described below are only examples of possible implementations. Other functional blocks may be used in other implementations without departing from the spirit and scope of the detailed description. Also, although one or more functional blocks of the present invention are represented as individual blocks, one or more of the functional blocks of the present invention may be a combination of various hardware and software configurations that perform the same function.

Also, the expression that includes certain components is an open expression and simply refers to the existence of the components, and should not be understood as excluding additional components.

Furthermore, when it is mentioned that a component is connected to or connected to another component, it should be understood that other components may be directly connected or connected to the other component.

In addition, expressions such as'first and second' are expressions used only for distinguishing a plurality of components, and do not limit the order or other features between components.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.

1 is a view showing a system (1) for implementing a clinical trial data processing and verification method according to an embodiment of the present invention.

Referring to FIG. 1, a system 1 for performing a clinical trial data processing and verification method according to an embodiment of the present invention includes a hospital terminal 10, a clinical trial data processing and verification apparatus 100, and a patient terminal 20 ).

The hospital terminal 10 is a terminal that can be used in a hospital conducting a clinical trial, and transmits clinical trial data of the patient to the clinical trial data processing and verification device 100. At this time, the clinical trial data may include information corresponding to the purpose of the database 101. The database 101 may include patient's disease information, tissue image information, genetic information, pathology information, medication history information, side effect information, blood test information, and clinical trial information such as a hospital visit date. The database 101 may include an electronic case record sheet (eCRF). The database 101 may include information on a form of a case record (CRF) used for a specific clinical trial and a variable related thereto. The database 101 may include information on a test record form for each hospital such as blood test/chemical test.

The clinical trial data processing and verification device 100 receives the patient's first clinical trial data from the hospital terminal 10. Meanwhile, the clinical trial data processing and verification apparatus 100 receives the second clinical trial data of the patient from the patient terminal 20. The clinical trial data processing and verification device 100 processes the second clinical trial data input by the patient into a standard data format. The standard data format may be a CDISC (Clinical Data Interchange Standards Consortium) method, but the present invention is not limited thereto.

The clinical trial data processing and verification device 100 compares the first clinical trial data inputted through the hospital terminal 10 and the processed second clinical trial data. The clinical trial data processing and verification device 100 converts the first clinical trial data (or second clinical trial data) into final data when the first clinical trial data and the (processed) second clinical trial data match. If the first clinical trial data and the second clinical trial data do not match, the hospital terminal 10 may be notified. Confirmation data may be stored in the database 101. At this time, the hospital terminal 10, the clinical trial data processing and verification device 100 and the patient terminal 20 may transmit and receive information through a wired or wireless network.

The patient terminal 20 is a terminal that can be used by a patient or a guardian who participates in a clinical trial, and transmits the patient's clinical trial data to the clinical trial data processing and verification device 100. The transmitted data may be text format data.

A clinical trial data processing and verification method for realizing a system 1 for implementing a clinical trial data processing and verification method according to an embodiment of the present invention will be described with reference to FIG. 2.

2 is a flowchart illustrating a comprehensive process of a method for processing and verifying clinical trial data according to an embodiment of the present invention. Each step of the clinical trial data processing and verification method according to FIG. 2 may be performed by the clinical trial data processing and verification device 100. The steps performed by the clinical trial data processing and verification device 100 will be described as follows.

Clinical trial data verification method according to an embodiment, receiving the first clinical trial data of the patient from the hospital terminal 10 (S100), receiving the second clinical trial data of the patient from the terminal of the patient (S200), processing the second clinical trial data into a standard data format (S300); The first clinical trial data is compared with the second clinical trial data, and if the first clinical trial data and the second clinical trial data match, the first clinical trial data is converted into final data, and the first clinical trial data is compared. And a data verification step (S400) of notifying the hospital terminal 10 when the test data and the second clinical trial data do not match.

Referring to FIG. 2, in the clinical trial data processing and verification apparatus 100, a step (S100) of receiving the patient's first clinical trial data from the hospital terminal 10 is performed. The hospital terminal 10 may be mainly used by a clinical research nurse (CRC), and the clinical research nurse (CRC) performs various tests/questions, etc. after a patient visits the hospital for a clinical trial. 1 Enter clinical trial data. The first clinical trial data include, for example, demographic information, lab results generated during the clinical trial, adverse event information, concomitant medication information, hospital visit date, etc. However, the present invention is not limited thereto.

On the other hand, the step (S200) of receiving the patient's second clinical trial data from the patient terminal 20 in the clinical trial data processing and verification apparatus 100 is performed. In the present specification and drawings, for convenience, receiving the first clinical trial data of the patient from the hospital terminal 10 (S100) and then receiving the second clinical trial data of the patient from the patient terminal 20 (S200) are performed. As described above, the present invention is not limited thereto. The temporal order of the two steps (S100, S200) may be reversed to the above, or may be performed substantially simultaneously.

The patient terminal 20 can be used by the patient himself or the guardian. The patient visits the hospital for clinical trials, performs various tests/questions, etc., and inputs the second clinical trial data. The second clinical trial data includes, for example, demographic information, lab results generated during the clinical trial, adverse event information, concomitant medication information, hospital visit date, etc. However, the present invention is not limited thereto. After the patient receives a copy of his/her medical records from the hospital for data input, the second clinical trial data can be input through the patient terminal 20 based on the patient's copy. Alternatively, the patient may receive a copy of his/her medical record electronically using a mobile app provided by the hospital or other online system.

Patients can view/grant copies of their medical records in paper form or electronically, so they can check all the source data about themselves generated in the hospital. Therefore, the patient can participate in source data verification (SDV) during the clinical trial process through the patient terminal 20.

According to an embodiment, the step of receiving the second clinical trial data of the patient from the patient's terminal is when the patient's terminal's location information is within a certain distance to the location of the hospital performing the clinical trial. And receiving a date as a visit day.

When the clinical research nurse (CRC) inputs clinical trial data in the hospital terminal 10, it is known that a high proportion of incorrectly entering the date among the total misspellers. In one embodiment, the location information of the patient terminal 20 is collected and the visit day is automatically estimated and received as the second clinical trial data. For example, when patient P performs a clinical trial in hospital H, the clinical trial data processing and verification device 100 is patient P when the location of the patient terminal 20 is within a certain distance (eg, 100 m) from the coordinates of hospital H It is judged that H visited the hospital and can automatically calculate a visit day.

On the other hand, if there is an unscheduled visit of a patient, the clinical trial data processing and verification device 100 may transmit information about this to the hospital terminal 10. In this case, even if the patient does not inform the clinical research nurse (CRC) whether or not the patient is separately visited, the clinical research nurse (CRC) can confirm that there has been an unscheduled visit and inquire about the patient.

Thereafter, the step (S300) of processing the second clinical trial data in the standard data format in the clinical trial data processing and verification apparatus 100 is performed.

3 is an example of a copy of a medical record based on a mobile app. This is a screen capture of a patient app provided by A hospital in Korea. In order to protect personal information, some values have been modified differently from actual values. [Table 1] below is the result of copying the text as it is from the patient app (app) of FIG.

[General blood] 2018/02/01
Result report date: 2018/02/01
Normal reference value
WBC [white blood cell count] 3.60 4~10 Х10³/μl
RBC [Red blood cell count] 3.34 4~5.4 Х10^6/μl
Hb [hemoglobin] 10.7 12~16 g/dL
Hct [Hematocrete] 32.1 36~48%
MCV 96.1 79~95 fL
MCH 32.0 26~32 pg
MCHC 33.3 32~36 g/dL
RDW [Red blood cell distribution coefficient] 18.3 11.5~14.5%
Platelet [Number of platelets] 252 130~400 Х10³/μl
PCT 0.16 0.15~0.32%
MPV 6.2 7.4~10.4 fL
PDW [platelet distribution coefficient] 16.6 9.9~16 fL
Seg.neut. 67.5 50~75%
Lymphocyte 15.1 20~44%
Monocyte 10.2 2~9%
Eosinophil 6.0 1-5%
Basophil 1.2 0-2%
ANC 2430 1800~7000 /μl

The blood test results illustrated in FIG. 3 and [Table 1] follow the format used in the medical records system (EMR) in a specific hospital. However, this format is different from the data format required in clinical trials. In addition, since each hospital uses its own format, a function is required to receive the second clinical trial data from the patient terminal and convert it into a standard data format for clinical trials. The standard data format for clinical trials may be CDISC format, but the present invention is not limited thereto. According to an embodiment, the step of processing the second clinical trial data into a standard data format may include extracting keywords from the second clinical trial data and assigning a variable name corresponding to the keyword from a database. It may include steps.

According to an embodiment, the step of processing the second clinical trial data into a standard data format may include extracting keywords such as [blood], [chemical], or [yo] from the second clinical trial data input from the patient terminal, and then category. (category) may include assigning a variable.

The clinical trial data processing and verification device recognizes that the text data input to the patient terminal contains the keyword [blood], and then the category of [hetatology] (hematology) in the second clinical trial data input from the patient terminal ( category) variables can be assigned (see FIG. 3 and [Table 1]).

According to an embodiment, the step of processing the second clinical trial data into a standard data format may include extracting variable names and units from the second clinical trial data input from the patient terminal and converting them into standard variable names and units. It can contain.

Table 2 below shows some of the results of blood tests in clinical trials at two different hospitals in Korea.

2nd clinical trial data By data processing
Standard data format Patient A (Hospital A) Patient B (hospital B) Variable name unit Hb [hemoglobin] 10.7 12~16 g/dL Hemoglobin, Blood
(Unit: g/dL) Result 12.0 Hemoglobin g/dL Hct [Hematocrete]32.1 36~48% Hematocrit, Blood
(Unit: %) Result 36.9 Hematocrit % ANC 2430 1800~7000 /μl ANC (Absolute Neutrophil Count) (unit: x10³/μL) Result 1.32 ANC (Absolute Neutrophil Count) /Μl

The data entered by the A and B patients through the terminal is a copy of the results from the apps provided by the A and B hospitals, respectively. Referring to [Table 2], the data format of hospital A consists of [variable name, result value, normal range, unit], and the data format of hospital B consists of [variable name, unit, result value]. On the other hand, the names of the corresponding variables do not match each other, and there are cases where the units used are also different (eg, A hospital uses [/μl] and B hospital uses [x10³/μL)] units). . Accordingly, the clinical trial data processing and verification device performs a step of processing the second clinical trial data input in another format into a standard data format. For example, the clinical trial data processing and verification device recognizes that the text data input to the patient terminal includes the keywords [Hb] or [Hemoglobin, Blood], and then displays [Hemoglobin] in the second clinical trial data input from the patient terminal. ] Can be given a variable name.

According to an embodiment, the step of processing the second clinical trial data into a standard data format may include correcting a result value of the second clinical trial data according to a standard unit.

For example, in the clinical trial data processing and verification device, a unit of 2430, which is the result of ANC among text data input to the patient A terminal, is [/µl], and of the text data input to the patient B terminal of the ANC (Absolute Neutrophil Count) After finding out that the result value of 1.32 is [ x10³/μL ], the result of the ANC input to the B patient terminal in accordance with [/µ], the standard unit for [ANC], among the second clinical trial data input from the patient terminal. The value '1.32' can be corrected to '1320'.

That is, data related to ANC among the second clinical trial data input by patient B is processed as follows.

Variable name value unit Before processing ANC (Absolute Neutrophil Count) 1.32 x10³/μL After processing ANC (Absolute Neutrophil Count) 1320 /Μl

That is, in the step of processing the second clinical trial data into a standard data format, a step of extracting variable names from text data received from each patient terminal and correcting the standardized variable names may be performed. In addition, after extracting the unit of the result value from the text data received from each patient terminal, a step of correcting the result value according to the standardized unit may be performed. It is needless to say that the above-described variable names, correction methods, and the like are only illustrative and do not limit the present invention. Meanwhile, the standard data format, standard variable names, and standard units may be preset when designing a clinical trial.

Thereafter, a data verification step (S400) is performed in the clinical test data processing and verification device 100. In the data verification step (S400), the first clinical trial data is compared with the processed second clinical trial data. If the two data match, the data verification device 100 converts the first clinical trial data into confirmed data. If the two data do not match, the clinical trial data processing and verification device 100 notifies the hospital terminal 10.

Hereinafter, an embodiment of the present invention will be described by taking the case where the data transmitted from the hospital terminal 10 and the patient terminal 20 is information regarding a lab result during a clinical trial.

For example, the clinical research nurse (CRC) performs the blood test and then, based on the data input to the EMR, the first clinical trial data related to the laboratory test is sent to the clinical trial data processing and verification device 100 through the hospital terminal 10. Can be sent. Meanwhile, the patient copies the source data of the'blood test result' electronically issued through the app of the hospital performing the clinical trial and pastes it in a separate app for the clinical trial for laboratory testing. The second clinical trial data may be transmitted to the clinical trial data processing and verification device 100 through the patient terminal 20.

Table 4 below is a partial example of the first clinical trial data and the second clinical trial data received by the apparatus 100 for processing and verifying clinical trial data.

ANC (unit) 1st clinical trial data 1320 (/μl) 2nd clinical trial data 1320 (/μl) Match Same Confirmed data 1320

Looking at [Table 4], the first clinical trial data and the second clinical trial data values respectively received from the hospital terminal 10 and the patient terminal 20 coincide with '1320'. Since the values of the data input separately from the two terminals are identical, in this case, it can be expected that both the clinical research nurse (CRC) and the patient's data input were correct. In this case, the clinical trial data processing and verification device 100 converts the first clinical trial data into'confirmed data'. The determined data may mean data for which source data verification (SDV) has been completed. The clinical trial data processing and verification device 100 may store the finalized data in the final database 101. In this case, the final data of'ANC' used to prepare the results report of the clinical trial is '1320'. Meanwhile, the clinical trial data processing and verification apparatus 100 may transmit a signal that the first clinical trial data has been verified to the hospital terminal 10.

According to an embodiment of the present invention, the verification of the source data is performed by comparing the data inputted in two different places through the clinical test data processing and verification device 100 rather than by the human eye. On the other hand, because different patients perform their own data verification tasks, the overall data verification period is shorter than that performed by any one institution.

In addition, the data entered by the patient is automatically processed into a standard data format, so that clinical trial data can be easily verified even in the case of clinical trials conducted in multiple centers.

The method for processing and verifying clinical trial data according to an embodiment may further include the step of assigning a first reward point to the patient terminal 20 after converting the first clinical trial data into finalized data. The clinical trial data processing and verification apparatus 100 may provide a first reward point to the patient terminal 20 to compensate for the patient's participation in the data verification (SDV) process. The first reward point may be, for example, digitized cash, points, gift certificates, cryptocurrency, contribution, reliability, rank, digital assets such as emoticons, etc., but the present invention is not limited thereto.

Table 5 below is another example of the first clinical trial data and the second clinical trial data received by the apparatus 100 for processing and verifying clinical trial data.

ANC (unit) 1st clinical trial data 1.32 (x10³/μL) 2nd clinical trial data 1320 (/μl) Match Inconsistency Confirmed data 1320 (/μl)

In Table 5, unlike Table 4, the first clinical trial data and the second clinical trial data values received from the hospital terminal 10 and the patient terminal 20 are inconsistent with each other as '1.32' and '1320'. do. In this case, the clinical trial data processing and verification device 100 notifies the hospital terminal 10. In this case, the clinical research nurse (CRC) using the hospital terminal 10 can check which value is correct by referring to the source data related to'ANC'. In this case, it can be estimated that the clinical research nurse (CRC) made a mistake in entering the data without converting the unit.

The method for processing and verifying clinical trial data according to an embodiment may further include receiving third clinical trial data from the hospital terminal 10 after the data verification stage and converting third clinical trial data into finalized data. Can be. The third clinical trial data may be correction data input by a clinical research nurse (CRC) using the hospital terminal 10. In other words, if the query of the discrepancy between the first clinical trial data and the second clinical trial data is received, the clinical research nurse (CRC) may check the source data again, and then input the corrected data value, the third clinical trial data, The clinical trial data processing and verification device 100 may receive the third clinical trial data and convert it into finalized data.

The method for processing and verifying clinical trial data according to an embodiment may further include assigning a second compensation point to the patient terminal 20 after the step of converting the third clinical trial data into finalized data. The clinical trial data processing and verification device 100 may provide a second reward point to the patient terminal 20 to compensate for the patient's participation in the data verification (SDV) process. The second reward point may be, for example, digitized cash, points, gift certificates, cryptocurrency, contribution, trustworthiness, rank, digital assets such as emoticons, etc., but the present invention is not limited thereto.

According to an embodiment, the second compensation point may be greater than the first compensation point. When the first reward point is granted, it is the case that the patient confirms that the value of the data entered by the clinical research nurse (CRC) is correct. This is the case when a data entry error is caught. That is, since the contribution of catching a data input error is greater in terms of data verification, the second compensation point is larger than the first compensation point, so that the patient can be more accurately input data through the patient terminal 20. .

According to one embodiment, the second clinical trial data is photographic data related to medical records, and the data verification step may include a step of converting and purifying the photographic data into text.

The'OCR reading text data' in [Table 6] below is actual data converted from the screenshot of FIG. 3 into text using optical character recognition (OCR) technology.

Prosecutor result Normal reference value WBC [white blood cell count] 3.60 4-10 X10 ³ /p≪ RBC [Red blood cell count] 3.34 4-5.4 X10 ^A 6/ Hb [Hemoglobin:！ 10.7 12-16 g/dL Het [Hematocrete] 32.1 3648% MCV 96.1 79-95 fL MCH 32.0 2632 pg MCHC 33.3 3236 g/dL RDW [Red blood cell distribution coefficient] 18.3 11.514.5% Platelet [Number of platelets] 252 130-400 X10 ³ / PCT 0.16 0.150.32% MPV 6.2 7.4-10.4 fL PDW [platelet distribution coefficient] 16.6 9.9-16 fL Seg.neut. 67.5 50-75% Lymphocyte 15.1 20-44% Monocyte 10.2 2-9%

When [Table 6] and FIG. 3 are compared, the actual value [Hct] is incorrectly recognized as [Het], and the units of WBC, RBC, and Platelet are missing.

According to one embodiment, the clinical trial data processing and verification device 100 converts the second clinical trial data (photo data) into text in the patient terminal 20 to confirm whether the purified results match the values shown in the screenshot. You can send a message asking for it.

If the patient determines that the source data and the OCR read text data are different, the patient may re-enter the second clinical trial data through the patient terminal 20 to match the value of the source data.

That is, it is possible to verify data by inputting data primarily through the OCR and by directly entering data through the patient terminal 20 to allow the patient to clear data. Accordingly, the quality of data verification is improved.

According to an embodiment, the clinical trial data processing and verification apparatus 100 may transparently manage the first clinical trial data and the second clinical trial data reception and modification history on a blockchain.

For example, the clinical trial data processing and verification device 100 generates a block including information obtained based on the patient's clinical trial data, and connects to blocks of other patients who have participated in the construction of the database 101 to block on the blockchain. Can be stored in.

For example, when the clinical trial data processing and verification apparatus 100 receives clinical trial data from a new patient, the public key of the patient corresponding to the identification information (or address), included in the clinical trial data A block including information (time-series information, qualitative information, or quantitative information) and a reward point may be generated and connected to a block containing information of a previous patient.

On the other hand, the information to be recorded in the block may be information including digital identification information and clinical trial data of the patient, but may be designed so that information to be recorded on the blockchain and information to be stored on the server are separately divided according to the administrator's selection. .

Meanwhile, the clinical trial data processing and verification apparatus 100 according to an embodiment of the present invention may include a reception unit, a standard data processing unit, and a data verification unit.

The reception unit may receive the first clinical trial data and the second clinical trial data from the hospital terminal 10 and the patient terminal 20, respectively.

The standard data processing unit may process the second clinical trial data in a standard data format.

The data verification unit compares the first clinical trial data and the second clinical trial data, and if the first clinical trial data and the second clinical trial data match, converts the first clinical trial data into final data, and the first clinical trial data and When the second clinical trial data do not match, the hospital terminal 10 may be notified.

On the other hand, the process for the components included in the clinical trial data processing and verification apparatus 100 according to the above-described embodiment to perform the corresponding operation has been described with reference to FIGS. 2 to 3, so a duplicate description is omitted.

Meanwhile, the receiving unit included in the above-described embodiment, the data verifying unit may be implemented by a computing device including a memory including instructions programmed to perform their functions, and a microprocessor performing these instructions.

According to the above-described embodiment, the quality of the clinical trial data is verified by allowing the patient who can access the clinical trial data to participate in the source data verification (SDV) without verifying personal information to verify the clinical trial data. Improve it. On the other hand, reward points can be given to patients who have contributed to the improvement of data quality in clinical trials, leading to voluntary participation of patients.

The above-described embodiments of the present invention can be implemented through various means. For example, embodiments of the present invention may be implemented by hardware, firmware, software, or a combination thereof.

For implementation by hardware, the method according to embodiments of the present invention includes one or more Application Specific Integrated Circuits (ASICs), Digital Signal Processors (DSPs), Digital Signal Processing Devices (DSPDs), Programmable Logic Devices (PLDs) , Field Programmable Gate Arrays (FPGAs), processors, controllers, microcontrollers, microprocessors, and the like.

In the case of implementation by firmware or software, the method according to embodiments of the present invention may be implemented in the form of a module, procedure, or function that performs the functions or operations described above. A computer program in which software code or the like is recorded may be stored in a computer-readable recording medium or memory unit and driven by a processor. The memory unit is located inside or outside the processor, and can exchange data with the processor by various means already known.

Also, combinations of each block of the block diagram and each step of the flowchart attached to the present invention may be performed by computer program instructions. These computer program instructions may be mounted on an encoding processor of a general purpose computer, special purpose computer, or other programmable data processing equipment, so that the instructions performed through the encoding processor of a computer or other programmable data processing equipment may include each block in the block diagram or In each step of the flowchart, means are created to perform the functions described. These computer program instructions can also be stored in computer readable or computer readable memory that can be oriented to a computer or other programmable data processing equipment to implement functionality in a particular way, so that computer readable or computer readable memory The instructions stored in it are also possible to produce an article of manufacture containing instructions means for performing the functions described in each block or flowchart step of the block diagram. Computer program instructions can also be mounted on a computer or other programmable data processing equipment, so a series of operational steps are performed on a computer or other programmable data processing equipment to create a process that is executed by the computer to generate a computer or other programmable data. It is also possible for instructions to perform processing equipment to provide steps for performing the functions described in each block of the block diagram and in each step of the flowchart.

In addition, each block or each step can represent a module, segment, or portion of code that includes one or more executable instructions for executing a specified logical function. It should also be noted that in some alternative embodiments it is possible that the functions mentioned in blocks or steps occur out of order. For example, two blocks or steps shown in succession may in fact be executed substantially simultaneously, or it is also possible that the blocks or steps are sometimes performed in reverse order depending on the corresponding function.

As such, those skilled in the art to which the present invention pertains will appreciate that the present invention may be implemented in other specific forms without changing its technical spirit or essential features. Therefore, it should be understood that the embodiments described above are illustrative in all respects and not restrictive. The scope of the present invention is indicated by the following claims rather than the detailed description, and all changes or modifications derived from the meaning and scope of the claims and equivalent concepts should be interpreted to be included in the scope of the present invention. .

10: hospital terminal
100: clinical trial data verification and processing equipment
101: database
20: Patient terminal

Claims (3)

Receiving first clinical trial data of the patient from the hospital terminal;
Receiving the second clinical trial data of the patient from the patient's terminal;
Processing the second clinical trial data into a standard data format;
The first clinical trial data is compared with the second clinical trial data, and if the first clinical trial data and the second clinical trial data match, the first clinical trial data is converted into final data, and the first clinical trial data is compared. A data verification step of notifying the hospital terminal when test data and the second clinical trial data do not match; including, clinical trial data processing and verification method.
According to claim 1,
Receiving the second clinical trial data of the patient from the terminal of the patient;
Including from the location information of the terminal of the patient, receiving a date when a date near a certain distance to the location of the hospital performing the clinical trial (visit day); including, clinical trial data processing and verification method.
According to claim 1,
Processing the second clinical trial data into a standard data format;
Extracting a variable unit from the second clinical trial data;
Comprising the step of correcting the result of the variable in accordance with the standard unit; including, clinical trial data processing and verification method.

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