Clinical test data management system and method

Abstract

The embodiment of the invention provides a clinical test data management system and method, and the system comprises an adverse event confirmation unit which is suitable for obtaining clinical test data, and when it is determined that an event corresponding to the clinical test data is consistent with a preset adverse event, determining that the event is consistent with the preset adverse event; taking events corresponding to the clinical test data as adverse events; the adverse event classification unit is suitable for classifying the adverse events corresponding to the clinical test data according to the types of the adverse events; the adverse event evaluation unit is suitable for evaluating each adverse event according to a preset evaluation standard and determining the priority of each adverse event; an adverse event recording unit; an adverse event generation unit; an adverse event analysis unit; an adverse event association unit; and an adverse event management unit. By the adoption of the technical scheme, adverse events occurring in the clinical test process can be monitored and managed, the adverse events are processed, and the safety of the clinical test is improved.

Description

Technical Field

[0001] The embodiments of this specification relate to the field of data processing technology, and more particularly, to a clinical trial data management system and method. Background Art

[0002] The Clinical Trial Adverse Event Reporting System is a system used to collect, record, manage, and report adverse events that occur during clinical trials. As part of the clinical trial data management system, it aims to ensure the effective handling, monitoring, and reporting of adverse events to safeguard trial safety. This allows research teams to better manage and monitor adverse events during trials and ensure compliance with regulatory requirements to protect subject safety and trial reliability.

[0003] In this context, how to provide technical solutions to manage adverse events that occur during clinical trials has become a technical problem that technical personnel in this field urgently need to solve. Summary of the Invention

[0004] In view of this, the embodiments of this specification provide a clinical trial data management system and method, which can monitor adverse events occurring during clinical trials, handle adverse events, and improve the safety of clinical trials.

[0005] This embodiment of the specification provides a clinical trial data management system, including:

[0006] an adverse event confirmation unit, adapted to obtain clinical trial data and, upon determining that an event corresponding to the clinical trial data is consistent with a preset adverse event, to treat the event corresponding to the clinical trial data as an adverse event;

[0007] an adverse event classification unit, adapted to classify the adverse events corresponding to the clinical trial data according to the type of the adverse event;

[0008] An adverse event assessment unit, adapted to assess each adverse event according to pre-set assessment criteria and determine the priority of each adverse event;

[0009] An adverse event recording unit, adapted to record each adverse event and determine an identification code corresponding to each adverse event;

[0010] An adverse event generation unit, adapted to generate an adverse event report file corresponding to each adverse event according to a pre-set event generation template;

[0011] Adverse event analysis unit, suitable for determining the severity of each adverse event, the cause of each adverse event, and the development trend of each adverse event based on each adverse event report document;

[0012] Adverse event association unit, suitable for evaluating the association between each adverse event and the trial intervention, and associating each adverse event with subject information;

[0013] The adverse event management unit is suitable for monitoring and handling each adverse event according to a pre-established safety monitoring plan.

[0014] Optionally, the adverse event confirmation unit includes:

[0015] Adverse event information provision module, suitable for providing additional documents and supporting materials used to characterize adverse events;

[0016] An adverse event entry module, adapted to input and record detailed information of the adverse event based on the additional documents and the supporting materials;

[0017] Adverse event integrity confirmation module, suitable for verifying the integrity of the input adverse event detailed information;

[0018] An adverse event description module is adapted to describe the characteristics of each adverse event based on the provided detailed information of the adverse event;

[0019] an adverse event confirmation module, adapted to obtain the clinical trial data and, upon determining that the event characteristics corresponding to the clinical trial data are consistent with the characteristics of the adverse event, to treat the event corresponding to the clinical trial data as an adverse event;

[0020] Adverse event time recording module, suitable for recording the occurrence time and duration of each adverse event;

[0021] The adverse event cause storage module is suitable for storing the cause of each adverse event.

[0022] Optionally, the adverse event classification unit includes: an adverse event classification standard providing module, suitable for providing a structured adverse event classification system; an adverse event classification type providing module, suitable for providing multiple different types of adverse event options corresponding to the adverse event classification system; an adverse event classification module, suitable for classifying each adverse event according to the type of the adverse event and the adverse event options.

[0023] Optionally, the adverse event assessment unit includes: an adverse event assessment standard providing module, suitable for providing standardized adverse event severity assessment standards; an adverse event assessment module, suitable for determining the priority of each adverse event based on the adverse event severity assessment standards, wherein the priority is used to characterize the severity of the adverse event; an adverse event management plan module, suitable for determining measures for handling adverse events based on the priority of each adverse event; and an adverse event reporting module, suitable for reporting the adverse event to an operator when it is determined that the severity of the corresponding adverse event is higher than a preset severity.

[0024] Optionally, the adverse event recording unit includes: an adverse event recording standard providing module, suitable for providing a record database, wherein the record database includes detailed information of all adverse events; an adverse event recording module, suitable for recording each adverse event according to the record database; and an adverse event marking module, suitable for determining an identification code corresponding to each adverse event according to a predefined label.

[0025] Optionally, the adverse event generation unit includes: an adverse event generation template providing module, suitable for providing an event generation template, the event generation template including information for generating adverse events; an adverse event filling module, suitable for filling in information for generating adverse events based on recorded adverse events; an adverse event generation module, suitable for generating the adverse event report file based on the event generation template and the filling information generated by the adverse event filling unit; an adverse event review module, suitable for reviewing and editing the content of the adverse event report file; an adverse event transmission module, suitable for uploading the reviewed and edited adverse event report file to the system or operator in a preset manner; an adverse event tracking module, suitable for recording the submission time and status of the adverse event report file, and tracking the processing progress of the adverse event report file; an adverse event archiving module, suitable for archiving and filing the adverse event report file.

[0026] Optionally, the adverse event analysis unit includes: an adverse event summary module, suitable for statistics and summary of adverse event data based on the adverse event report file, the adverse event data including: the total number, distribution and severity of adverse events; an adverse event analysis module, suitable for determining the severity and distribution type of the adverse events based on the parameters of the adverse event data, and suitable for comparative analysis of each adverse event to determine the cause of occurrence and development trend of the adverse event.

[0027] Optionally, the adverse event management unit includes: an adverse event monitoring plan module, which is suitable for formulating a safety monitoring plan and providing monitoring indicators; an adverse event safety monitoring module, which is suitable for real-time monitoring of safety events during the trial according to the safety monitoring plan, wherein the safety events include the occurrence and severity of adverse events; an adverse event safety verification module, which is suitable for detecting safety monitoring signals corresponding to potential adverse events through data analysis and statistical methods, and verifying and confirming the safety monitoring signals; an adverse event safety management module, which is suitable for managing the events corresponding to the safety monitoring signals when determining that the events corresponding to the safety monitoring signals are adverse events, and recording the processing procedures of the events corresponding to the safety monitoring signals; an adverse event safety supervision reporting module, which is suitable for generating safety supervision reports that meet regulatory requirements; and an adverse event communication content storage module, which is suitable for storing information on adverse event coordination and communication.

[0028] Optionally, the clinical trial data management system further includes: an adverse event feedback unit, adapted to generate a corresponding feedback report based on the analysis results of the adverse event analysis unit and the evaluation results of the adverse event evaluation unit; and an adverse event marking unit, adapted to define information of each adverse event.

[0029] Correspondingly, an embodiment of this specification also provides a clinical trial data management method, including: when it is determined that the event corresponding to the acquired clinical trial data is consistent with the preset adverse event, the event corresponding to the clinical trial data is treated as an adverse event; according to the type of the adverse event, the adverse event corresponding to the clinical trial data is classified and processed; according to the pre-set evaluation criteria, each adverse event is smoothed and the priority of each adverse event is determined; each adverse event is recorded and an identification code corresponding to each adverse event is determined; according to a pre-set event generation template, an adverse event report file corresponding to each adverse event is generated; according to each adverse event report file, the severity of each adverse event, the cause of each adverse event, and the development trend of each adverse event are determined; the correlation between each adverse event and the trial intervention is evaluated, and each adverse event is associated with the subject information; according to a pre-established safety monitoring plan, each adverse event is monitored and processed.

[0030] By adopting the clinical trial data management scheme in the embodiment of this specification, when it is determined that the event corresponding to the clinical trial data is consistent with the preset adverse event, the event corresponding to the clinical trial data is used as an adverse event, and then each adverse event can be classified and processed according to the type of adverse event, so that each adverse event can be evaluated according to the pre-set evaluation criteria, and the priority of each adverse event can be determined; and when an adverse event occurs, each adverse event can be recorded, and the identification code corresponding to each adverse event can be determined, and then, according to the pre-set event generation template, an adverse event report file corresponding to each adverse event can be generated, and the severity of each adverse event, the cause of each adverse event, and the development trend of each adverse event can be determined through the adverse event report file, and by evaluating the correlation between each adverse event and the trial intervention, and associating each adverse event with the subject information, the relationship between the adverse event and the trial intervention, and the current state of the subject can be determined, and then each adverse event can be monitored and processed according to the pre-established safety monitoring plan. Therefore, by adopting the clinical trial data management scheme in the embodiment of this specification, adverse events occurring during the clinical trial can be monitored and processed, thereby improving the safety of the clinical trial. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying any creative work.

[0032] Figure 1 A schematic diagram of the structure of a clinical trial data management system according to an embodiment of this specification is shown;

[0033] Figure 2 A schematic structural diagram of an adverse event confirmation unit in an embodiment of this specification is shown;

[0034] Figure 3 A schematic structural diagram of an adverse event classification unit in an embodiment of this specification is shown;

[0035] Figure 4 A schematic structural diagram of an adverse event assessment unit according to an embodiment of this specification is shown;

[0036] Figure 5 A schematic structural diagram of an adverse event recording unit according to an embodiment of the present specification is shown;

[0037] Figure 6A schematic structural diagram of an adverse event generation unit in an embodiment of this specification is shown;

[0038] Figure 7 A schematic structural diagram of an adverse event analysis unit according to an embodiment of this specification is shown;

[0039] Figure 8 A schematic structural diagram of an adverse event management unit according to an embodiment of the present specification is shown;

[0040] Figure 9 A flow chart of a clinical trial data management method in an embodiment of this specification is shown. DETAILED DESCRIPTION

[0041] As described in the background art, the clinical trial adverse event reporting system is part of the clinical trial data management system, which aims to ensure the effective handling, monitoring and reporting of adverse events to protect the safety of the trial.

[0042] In order to monitor adverse events that occur during clinical trials, the embodiments of this specification provide a clinical trial data management system, which can, when determining that the event corresponding to the clinical trial data is consistent with the preset adverse event, treat the event corresponding to the clinical trial data as an adverse event, and then classify and process each adverse event according to the type of adverse event, so that each adverse event can be evaluated according to a pre-set evaluation standard, and the priority of each adverse event can be determined; and when an adverse event occurs, each adverse event can be recorded and the identification code corresponding to each adverse event can be determined, and then, according to a pre-set event generation template, an adverse event report file corresponding to each adverse event can be generated, and the severity of each adverse event, the cause of each adverse event, and the development trend of each adverse event can be determined through the adverse event report file, and by evaluating the correlation between each adverse event and the trial intervention, and associating each adverse event with the subject information, the relationship between the adverse event and the trial intervention, as well as the current status of the subject, can be determined, and then each adverse event can be monitored and processed according to a pre-established safety monitoring plan. Therefore, the clinical trial data management scheme in the embodiments of this specification is adopted to monitor adverse events that occur during clinical trials, process adverse events, and improve the safety of clinical trials.

[0043] In order to enable those skilled in the art to better understand and implement the embodiments of this specification, the concepts, schemes, principles and advantages of the embodiments of this specification are described in detail below with reference to the drawings and through specific application examples.

[0044] First, the embodiments of this specification provide a clinical trial data management system. In some embodiments of this specification, such as Figure 1As shown, the clinical trial data management system M may include an adverse event confirmation unit M1, an adverse event classification unit M2, an adverse event assessment unit M3, an adverse event recording unit M4, an adverse event generation unit M5, an adverse event analysis unit M6, an adverse event association unit M7 and an adverse event management unit M8, wherein:

[0045] The adverse event confirmation unit M1 is adapted to obtain clinical trial data and, when determining that an event corresponding to the clinical trial data is consistent with a preset adverse event, to treat the event corresponding to the clinical trial data as an adverse event;

[0046] The adverse event classification unit M2 is adapted to classify the adverse events corresponding to the clinical trial data according to the type of the adverse event;

[0047] The adverse event assessment unit M3 is adapted to assess each adverse event according to a pre-set assessment standard and determine the priority of each adverse event;

[0048] The adverse event recording unit M4 is adapted to record each adverse event and determine an identification code corresponding to each adverse event;

[0049] The adverse event generating unit M5 is adapted to generate an adverse event report file corresponding to each adverse event according to a preset event generation template;

[0050] The adverse event analysis unit M6 is adapted to determine the severity of each adverse event, the cause of each adverse event, and the development trend of each adverse event based on each adverse event report file;

[0051] The adverse event association unit M7 is adapted to evaluate the association between each adverse event and the trial intervention, and to associate each adverse event with subject information;

[0052] The adverse event management unit M8 is adapted to monitor and process each adverse event according to a pre-established safety monitoring plan.

[0053] Reference Figure 1 When clinical trial data is obtained, the adverse event confirmation unit M1 can determine whether the event corresponding to the clinical trial data is an adverse event, and when it is determined that the event corresponding to the clinical trial data is consistent with the preset adverse event, the adverse event confirmation unit M1 can regard the event corresponding to the clinical trial data as an adverse event, wherein the adverse event may refer to an event that causes harm to the subject during the clinical trial or when the trial data is abnormal.

[0054] The adverse event classification unit M2 can classify and process adverse events, and the adverse event evaluation unit M3 can evaluate the classified adverse events according to pre-set evaluation criteria. Then, the adverse event recording unit M4 can record information about the adverse events (such as the time of occurrence of the adverse event, the severity of the adverse event, etc.), and the adverse event generation unit M5 can generate adverse event report files corresponding to each adverse event.

[0055] Since the adverse event report file can reflect all the information of the current adverse event, the adverse event analysis unit M6 can determine the severity of each adverse event, the cause of each adverse event, and the development trend of each adverse event based on each adverse event report file, and by evaluating the correlation between each adverse event and the trial intervention, and associating each adverse event with the subject information, it can determine the relationship between the adverse event and the trial intervention, as well as the current status of the subject, and then the adverse event management unit M8 can monitor and handle each adverse event according to the pre-established safety monitoring plan.

[0056] Therefore, by adopting the clinical trial data management system in the embodiment of this specification, by determining, classifying, evaluating, recording, generating, analyzing, associating and managing operations, it is possible to monitor adverse events occurring during clinical trials, handle adverse events, and improve the safety of clinical trials.

[0057] It should be noted that the connection relationship between the units shown in the above embodiments is only an example. In some embodiments, the adverse event management unit can be connected to other units respectively; or, any two units in the clinical trial data management system can be connected. The embodiments of this specification do not impose any restrictions on the connection relationship between the units in the clinical trial data management system.

[0058] In order to enable those skilled in the art to better understand and implement the embodiments of this specification, some specific examples are given below for the specific implementation of the clinical trial data management system in the embodiments of this specification.

[0059] In some embodiments of this specification, reference is made to Figure 2 The schematic diagram of the structure of an adverse event confirmation unit in the embodiment of this specification is shown in FIG. Figure 2 As shown, the adverse event confirmation unit M1 may include: an adverse event data providing module M11, an adverse event entry module M12, an adverse event integrity confirmation module M13, an adverse event description module M14, an adverse event confirmation module M16, an adverse event time recording module M17 and an adverse event cause storage module M15, wherein:

[0060] The adverse event information providing module M11 is adapted to provide additional documents and supporting materials for characterizing adverse events;

[0061] The adverse event entry module M12 is adapted to input and record detailed information of the adverse event based on the additional documents and the supporting materials;

[0062] The adverse event integrity confirmation module M13 is adapted to verify the integrity of the input adverse event detailed information;

[0063] The adverse event description module M14 is adapted to describe the characteristics of each adverse event based on the provided detailed information of the adverse event;

[0064] The adverse event confirmation module M16 is adapted to obtain the clinical trial data and, upon determining that the event characteristics corresponding to the clinical trial data are consistent with the characteristics of the adverse event, to treat the event corresponding to the clinical trial data as an adverse event;

[0065] The adverse event time recording module M17 is adapted to record the occurrence time and duration of each adverse event;

[0066] The adverse event cause storage module M15 is suitable for storing the cause of each adverse event.

[0067] Specifically, the additional documents and supporting materials (which may be documents, pictures, laboratory reports, etc.) can represent any information related to adverse events. By referring to the additional documents and supporting materials, the specific adverse events can be identified, and then the adverse event entry module M12 can input and record detailed information of the adverse events based on the additional documents and the supporting materials.

[0068] As an optional example, clinical trial staff may input and record detailed information of adverse events through a user interface or form, or obtain relevant information from the Internet, and this manual does not impose any restrictions on this.

[0069] In a specific implementation, to prevent misjudgments due to missing adverse event information, the adverse event integrity confirmation module M13 can verify the integrity of the detailed information of the adverse event to ensure the integrity of the entered information and that the entered information complies with the prescribed format and requirements. The adverse event description module M15 can describe the characteristics of each adverse event based on the provided detailed information of the adverse event. Then, the adverse event confirmation module M16 can obtain the clinical trial data and, if it determines that the event characteristics corresponding to the clinical trial data are consistent with the characteristics of the adverse event, treat the event corresponding to the clinical trial data as an adverse event.

[0070] In some embodiments, the adverse event confirmation module M16 can obtain the cause of the adverse event from the adverse event cause storage module M14, so that the staff can provide preliminary speculation or hypothesis on the cause of the event based on clinical experience or relevant information.

[0071] In a specific implementation, when it is determined that an adverse event occurs, the adverse event time recording module M17 can record the occurrence time and duration of each adverse event.

[0072] In some embodiments, staff can record the specific date and time of occurrence of the adverse event and the duration of the event to better understand the temporal relationship and persistence of the adverse event.

[0073] It is understandable that the data generated during the above processing can be used to trace adverse events, so the processing data generated by the adverse event confirmation unit can be recorded, which facilitates subsequent data management, review, query and tracing.

[0074] Therefore, by using the adverse event confirmation unit in the above embodiment, the occurrence of adverse events can be determined based on the detailed information of the adverse events provided and the event characteristics corresponding to the clinical trial data. Moreover, since the detailed information of the adverse events is pre-set, there is no need for manual confirmation throughout the entire process, which can improve the confirmation efficiency and accuracy.

[0075] In specific implementations, the same adverse event may be caused by multiple reasons or one reason may cause multiple different adverse events. Therefore, when determining that an adverse event has occurred, the adverse event can be classified.

[0076] In some embodiments of this specification, reference is made to Figure 3 The schematic diagram of the structure of an adverse event classification unit in this manual is shown as Figure 3 As shown, the adverse event classification unit M2 may include: an adverse event classification standard providing module M21, an adverse event classification type providing module M22 and an adverse event classification module M13, wherein:

[0077] The adverse event classification standard providing module M21 is suitable for providing a structured adverse event classification system;

[0078] The adverse event classification type providing module M22 is adapted to provide a plurality of different types of adverse event options corresponding to the adverse event classification system;

[0079] The adverse event classification module M23 is adapted to classify each adverse event according to the type of the adverse event and the adverse event options.

[0080] Specifically, the adverse event classification standard providing module M21 provides a structured adverse event classification system that can be used to classify adverse events, and then the adverse event classification type providing module M22 can provide different types of adverse event options to obtain adverse event types with corresponding types. The adverse event classification module M23 can classify each adverse event based on the type of adverse event and the adverse event options.

[0081] In some embodiments of this specification, the classification system may be based on a standard medical classification system, such as MedDRA (Medical Dictionary Correlations) or WHO-ART (World Health Organization Adverse Reaction Terminology), or customized according to the specific classification requirements of the trial. The embodiments of this specification do not impose any restrictions on the type of classification system. For example, specific adverse event classification criteria may also be provided based on the needs of a specific trial, wherein these criteria may be based on the treatment regimen of the trial, observation indicators or other relevant factors. For example, for a specific drug trial, drug-related adverse event classification and evaluation criteria may be provided.

[0082] Therefore, the adverse event classification unit in the above embodiment is used to classify each adverse event based on the type of adverse event and the adverse event options, so that the adverse event can be processed according to the type. Since adverse events of the same type have commonalities, the subsequent processing efficiency can be improved.

[0083] In specific implementations, different measures are taken for different adverse events. In some embodiments of this specification, the priority of the adverse event can be determined, and specific response measures are determined based on the priority.

[0084] In some embodiments of this specification, reference is made to Figure 4 A schematic diagram of the structure of an adverse event assessment unit in this manual is shown as Figure 4 As shown, the adverse event classification unit M3 may include: an adverse event assessment standard providing module M31, an adverse event assessment module M32, an adverse event management plan module M33 and an adverse event reporting module M34, wherein:

[0085] The adverse event assessment criteria providing module M31 is adapted to provide standardized adverse event severity assessment criteria;

[0086] The adverse event assessment module M32 is adapted to determine the priority of each adverse event according to the adverse event severity assessment standard, wherein the priority is used to characterize the severity of the adverse event;

[0087] The adverse event management plan module M33 is adapted to determine measures for handling adverse events according to the priority of each adverse event;

[0088] The adverse event reporting module M34 is adapted to report the adverse event to the operator when it is determined that the severity of the corresponding adverse event is higher than a preset severity.

[0089] Specifically, the adverse event assessment standard providing module M31 can provide an assessment tool or guide for assessing the severity of adverse events, which can be mild, moderate, severe, etc.

[0090] The adverse event assessment module M32 can determine the priority of each adverse event, wherein the priority is used to characterize the severity of the adverse event. Then the adverse event management plan module M33 can monitor and track the adverse events, or further evaluate the requirements, related safety measures and corrective measures, etc., to ensure the safety of the trial and the welfare of the subjects, and the adverse event reporting module M34 will report the above evaluation results to the operator, wherein the operator can be a medical staff, regulatory agency personnel, research ethics committee, data monitoring committee and other relevant parties.

[0091] Therefore, by using the adverse event assessment unit in the above embodiment, the severity of the adverse event can be determined, and corresponding treatment measures can be taken when the severity is higher than the set severity, thereby ensuring the safety of the trial and the well-being of the subjects.

[0092] In order to facilitate traceability and better handle or warn of adverse events, all information about the adverse event can be recorded when it is determined that the adverse event has occurred.

[0093] As a specific example, refer to Figure 5 A schematic diagram of the structure of an adverse event recording unit in this manual is shown as Figure 5 As shown, the adverse event recording unit M4 may include: an adverse event recording standard providing module M41, an adverse event recording module M42 and an adverse event marking module M43, wherein:

[0094] The adverse event record standard providing module M41 is adapted to provide a record database, wherein the record database includes detailed information of all adverse events;

[0095] The adverse event recording module M42 is adapted to record each adverse event according to the record database;

[0096] The adverse event marking module M43 is adapted to determine the identification code corresponding to each adverse event based on a predefined label.

[0097] Specifically, the record database provided by the adverse event record standard providing module M41 can include detailed information of all adverse events, and then the adverse event record module M42 can record and track the handling process and progress of each adverse event, such as recording the handling measures for adverse events, the safety measures taken, and the communication records with subjects and regulatory agencies.

[0098] For some adverse events that are of research significance or have not occurred before, the adverse event marking module M43 can encode the adverse event to obtain a unique identification code.

[0099] In some embodiments of this specification, adverse events can also be automatically coded. As an optional example, the clinical trial data management system in the embodiments of this specification can also include an adverse event marking unit, which is suitable for defining information of each adverse event.

[0100] Therefore, the adverse event recording unit in the above embodiment can record the continuity and completeness of adverse events and ensure that necessary actions can be taken in a timely manner.

[0101] In actual implementation, multiple adverse events may occur at the same time, and the severity of different adverse events may be the same, and the measures adopted for them may also be different. Therefore, a report file corresponding to each adverse event can be generated separately.

[0102] For example, refer to Figure 6 The schematic diagram of the structure of an adverse event generation unit in this specification is shown in FIG. Figure 6 As shown, the adverse event generation unit M5 may include: an adverse event generation template providing module M51, an adverse event filling module M52, an adverse event generation module M53, an adverse event review module M54, an adverse event transmission module M55, an adverse event tracking module M56 and an adverse event archiving module M57, wherein:

[0103] The adverse event generation template providing module M51 is adapted to provide an event generation template, wherein the event generation template includes information for generating an adverse event;

[0104] The adverse event filling module M52 is adapted to fill in information for generating adverse events according to the recorded adverse events;

[0105] The adverse event generating module M53 is adapted to generate the adverse event report file according to the event generating template and the filling information generated by the adverse event filling unit;

[0106] The adverse event review module M54 is adapted to review and edit the contents of the adverse event report file;

[0107] The adverse event transmission module M55 is adapted to upload the reviewed and edited adverse event report file to the system or operator in a preset manner;

[0108] The adverse event tracking module M56 is adapted to record the submission time and status of adverse event report files and track the processing progress of adverse event report files;

[0109] The adverse event filing module M57 is adapted to file and archive the adverse event report files.

[0110] Specifically, the adverse event generation template providing module M51 can provide a predefined event generation template to ensure that the format and content of the subsequently generated adverse event report file meet regulatory requirements, wherein the event generation template usually includes necessary information, such as a description of the adverse event, relevant information of the subject, the severity of the adverse event, associated treatment and other relevant factors.

[0111] In a specific implementation, some useful information may be missing in the provided event generation template, so the adverse event filling module M52 can automatically fill in the necessary information in the adverse event report file based on the recorded adverse events, which can reduce manual input and improve the accuracy and efficiency of the report; then the adverse event generation module M53 can generate the adverse event report file based on the event generation template and the filled information generated by the adverse event filling unit.

[0112] In some embodiments, when an adverse event report file is generated, the content of the adverse event report file can also be reviewed and edited to ensure the accuracy and completeness of the adverse event report file, to ensure that all necessary information is included in the report, and then to make necessary corrections to the adverse event report file when errors are found. Afterwards, the reviewed and edited adverse event report file can be uploaded to the system or operator in a preset manner. For example, the adverse event report file can be uploaded through an electronic submission system, email, online platform or other suitable communication method. When the adverse event report file is received, the adverse event report file can be archived and filed to ensure the traceability and completeness of the report while meeting the requirements of the regulatory agency.

[0113] In some embodiments, the adverse event generation unit M5 may also record the submission time and status of the adverse event report file and track the progress of the report processing, for example, whether the adverse event report file has been received, whether further information or supplementary materials are required, etc.

[0114] Therefore, by using the adverse event generation unit in the above embodiment, when it is determined that an adverse event has occurred, a corresponding adverse event report file can be generated, which is convenient for relevant personnel to review. By automatically filling in the necessary information in the adverse event report file, manual input can be reduced and the accuracy and efficiency of the report can be improved.

[0115] After the adverse event report file is generated, the adverse event can also be analyzed in order to make the best treatment measures.

[0116] In some embodiments of this specification, reference is made to Figure 7 The schematic diagram of the structure of an adverse event analysis unit in this specification is shown in FIG. Figure 7 As shown, the adverse event analysis unit M6 may include: an adverse event summary module M61 and an adverse event analysis module M62, wherein:

[0117] The adverse event summary module M61 is adapted to collect and summarize adverse event data according to the adverse event report file, wherein the adverse event data includes: the total number, distribution, and severity of adverse events;

[0118] The adverse event analysis module M62 is adapted to determine the severity and distribution type of the adverse event based on the parameters of the adverse event data, and is adapted to conduct comparative analysis on each adverse event to determine the cause of occurrence and development trend of the adverse event.

[0119] Specifically, the adverse event summary module M61 can count and summarize adverse event data, for example, it can count the total number of adverse events, distribution, severity and other key indicators, which can help researchers and regulators understand the overall situation of adverse events in the trial, and then the adverse event analysis module M62 can analyze the severity of adverse events to understand the severity distribution and proportion of adverse events, for example, it can be presented by calculating the number and percentage of events of different severity levels. Among them, severity analysis helps to evaluate the impact of trial interventions on the safety of subjects, and through the severity distribution and proportion of adverse events, the trend of adverse events can be analyzed to detect and identify patterns and changes in the occurrence of events. Therefore, by generating charts, trend lines and statistical data, it can show the changes of events over time, helping researchers to evaluate the safety and risks of the trial.

[0120] In specific implementations, when an adverse event occurs, it can also be associated with other factors. For example, the adverse event association module can evaluate the association between the adverse event and the trial intervention, which can help determine whether there is a possible causal relationship and the temporal relationship between the event and the trial intervention. For another example, the adverse event association module can associate the adverse event with relevant information about the subject, where the relevant information about the subject may include the subject number, gender, age, treatment group, etc., so as to accurately identify the association between the adverse event and the subject in the report.

[0121] When an adverse event occurs, the adverse event can be treated. Figure 8 The schematic diagram of the structure of an adverse event management unit in this manual is shown as Figure 8 As shown, the adverse event management unit M8 may include: an adverse event monitoring plan module M81, an adverse event safety monitoring module M82, an adverse event safety testing module M83, an adverse event safety management module M84, an adverse event safety supervision reporting module M85 and an adverse event communication content storage module M86, wherein:

[0122] The adverse event monitoring plan module M81 is suitable for formulating a safety monitoring plan and providing monitoring indicators;

[0123] The adverse event safety monitoring module M82 is adapted to monitor safety events during the trial in real time according to the safety monitoring plan, wherein the safety events include the occurrence and severity of adverse events;

[0124] The adverse event safety detection module M83 is suitable for detecting safety monitoring signals corresponding to potential adverse events through data analysis and statistical methods, and verifying and confirming the safety monitoring signals;

[0125] The adverse event safety management module M84 is adapted to manage the event corresponding to the safety monitoring signal when it is determined that the event corresponding to the safety monitoring signal is an adverse event, and record the processing flow of the event corresponding to the safety monitoring signal;

[0126] The adverse event safety supervision reporting module M85 is suitable for generating safety supervision reports that meet regulatory requirements;

[0127] The adverse event communication content storage module M86 is suitable for storing adverse event coordination and communication information.

[0128] Specifically, the Adverse Event Monitoring Plan Module M81 supports the development of a safety monitoring plan, including the definition of monitoring indicators, frequency, and methods. Monitoring indicators can include adverse events, serious adverse events, laboratory indicators, physiological indicators, and other safety indicators related to the trial intervention. Furthermore, the Adverse Event Safety Monitoring Module M82 monitors safety events during the trial in real time, including the occurrence and severity of adverse events. It also provides real-time alerts and notifications, and monitors the trends and distribution of adverse events.

[0129] During this period, the adverse event safety testing module M83 can detect potential safety signals through data analysis and statistical methods, which may involve the use of statistical tools and algorithms to analyze the distribution, frequency and correlation of adverse events in order to identify unusual or increased safety risks associated with the trial intervention, and verify and confirm the detected potential safety signals, for example, which may include further data analysis, review of research literature, expert evaluation and other methods to determine the authenticity and clinical significance of the signal.

[0130] When the event corresponding to the safety monitoring signal is determined to be an adverse event, the adverse event safety management module M84 can manage the event corresponding to the safety monitoring signal and record the processing flow of the event corresponding to the safety monitoring signal, thereby generating a safety supervision report that meets regulatory requirements. The safety supervision report may include a safety monitoring plan, a safety event summary, signal detection and assessment results, safety signal management measures, etc., to provide regulatory agencies with trial safety data. At the same time, the adverse event communication content storage module M86 can also store information on adverse event coordination and communication, which can help ensure that the trial complies with applicable regulatory guidelines and regulations; the regulatory compliance database unit is used to store compliance with regulatory requirements.

[0131] In some embodiments of the present specification, the adverse event management unit may also include an adverse event monitoring and alarm module for real-time monitoring of adverse events and providing alarms or reminders to enable timely implementation of necessary measures. For example, a threshold or warning line may be set. Once the adverse event exceeds the set threshold, the system will automatically trigger an alarm and notify relevant personnel to take action.

[0132] The adverse event management unit may also include an adverse event management decision module to provide decision support tools to assist researchers or monitoring committees in making decisions regarding adverse event management. These decisions may include providing recommendations and guidance based on factors such as the severity, relevance, and potential risks of the event, such as whether to adjust the trial protocol, suspend the trial, or adjust the treatment dose.

[0133] The adverse event management unit may also include an adverse event management plan module for generating and managing an adverse event management plan, which may include monitoring and tracking measures for adverse events, further evaluation requirements, relevant safety measures and corrective measures, etc.

[0134] In some embodiments of this specification, after analyzing adverse events, a feedback report may be generated for learning. Based on this, the clinical trial data management system in the embodiments of this specification may also include an adverse event feedback unit adapted to generate a corresponding feedback report based on the analysis results of the adverse event analysis unit and the evaluation results of the adverse event evaluation unit.

[0135] Among them, feedback reports can include the root causes of adverse events, common patterns of adverse events, development trends of adverse events, improvement measures, etc., which can promote experience sharing and feedback exchanges among staff, thereby further improving the safety and quality of clinical trials.

[0136] It is understood that the above description provides multiple embodiments of the present specification. The various optional methods described in each embodiment can be combined and cross-referenced with each other without conflict, thereby extending to a variety of possible embodiments, all of which can be considered as embodiments disclosed and open to the public in this specification. For example, any unit in a clinical trial data management system can include a module with a recording function.

[0137] This specification also provides a clinical trial data management method corresponding to the above-mentioned clinical trial data management system, which is described in detail below through specific embodiments with reference to the accompanying drawings.

[0138] Reference Figure 9 In some embodiments of this specification, such as Figure 9 As shown, clinical trial data can be managed in the following steps:

[0139] S11, when it is determined that the event corresponding to the acquired clinical trial data is consistent with the preset adverse event, the event corresponding to the clinical trial data is regarded as an adverse event.

[0140] S12, classifying the adverse events corresponding to the clinical trial data according to the types of the adverse events.

[0141] S13, according to the pre-set evaluation criteria, each adverse event is smoothed out and the priority of each adverse event is determined.

[0142] S14, recording each adverse event and determining an identification code corresponding to each adverse event.

[0143] S15, generating an adverse event report file corresponding to each adverse event according to a preset event generation template.

[0144] S16. Determine the severity, cause, and development trend of each adverse event based on each adverse event report document.

[0145] S17, assess the association between each adverse event and the trial intervention, and associate each adverse event with subject information.

[0146] S18, monitor and handle each adverse event according to the pre-established safety monitoring plan.

[0147] By adopting the above clinical trial data management method, through identification, classification, evaluation, recording, generation, analysis, association and management operations, it is possible to monitor adverse events that occur during clinical trials, handle adverse events, and improve the safety of clinical trials.

[0148] Although the embodiments of this specification are disclosed above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention should be based on the scope defined by the claims.

Claims

1. A clinical trial data management system, characterized in that: include: an adverse event confirmation unit, adapted to obtain clinical trial data and, upon determining that an event corresponding to the clinical trial data is consistent with a preset adverse event, to treat the event corresponding to the clinical trial data as an adverse event; an adverse event classification unit, adapted to classify the adverse events corresponding to the clinical trial data according to the type of the adverse event; An adverse event assessment unit, adapted to assess each adverse event according to pre-set assessment criteria and determine the priority of each adverse event; An adverse event recording unit, adapted to record each adverse event and determine an identification code corresponding to each adverse event; An adverse event generation unit, adapted to generate an adverse event report file corresponding to each adverse event according to a pre-set event generation template; Adverse event analysis unit, suitable for determining the severity of each adverse event, the cause of each adverse event, and the development trend of each adverse event based on each adverse event report document; Adverse event association unit, suitable for evaluating the association between each adverse event and the trial intervention, and associating each adverse event with subject information; The adverse event management unit is suitable for monitoring and handling each adverse event according to a pre-established safety monitoring plan.

2. The clinical trial data management system according to claim 1, characterized in that: The adverse event confirmation unit includes: Adverse event information provision module, suitable for providing additional documents and supporting materials used to characterize adverse events; An adverse event entry module, adapted to input and record detailed information of the adverse event based on the additional documents and the supporting materials; Adverse event integrity confirmation module, suitable for verifying the integrity of the input adverse event detailed information; An adverse event description module is adapted to describe the characteristics of each adverse event based on the provided detailed information of the adverse event; an adverse event confirmation module, adapted to obtain the clinical trial data and, upon determining that the event characteristics corresponding to the clinical trial data are consistent with the characteristics of the adverse event, to treat the event corresponding to the clinical trial data as an adverse event; Adverse event time recording module, suitable for recording the occurrence time and duration of each adverse event; The adverse event cause storage module is suitable for storing the cause of each adverse event.

3. The clinical trial data management system according to claim 1, characterized in that: The adverse event classification unit includes: The adverse event classification standard provides modules suitable for providing a structured adverse event classification system; An adverse event classification type providing module, adapted to provide multiple adverse event options of different types corresponding to the adverse event classification system; The adverse event classification module is adapted to classify each adverse event according to the type of the adverse event and the adverse event options.

4. The clinical trial data management system according to claim 1, characterized in that: The adverse event assessment unit includes: Adverse event assessment criteria provide a module suitable for providing standardized adverse event severity assessment criteria; an adverse event assessment module, adapted to determine the priority of each adverse event according to the adverse event severity assessment criteria, wherein the priority is used to characterize the severity of the adverse event; Adverse event management plan module, which is suitable for determining measures to deal with adverse events based on the priority of each adverse event; The adverse event reporting module is adapted to report the adverse event to the operator when it is determined that the severity of the corresponding adverse event is higher than a preset severity.

5. The clinical trial data management system according to claim 1, characterized in that: The adverse event recording unit includes: An adverse event record standard providing module, adapted to provide a record database, wherein the record database includes detailed information of all adverse events; An adverse event recording module, adapted to record each adverse event according to the record database; The adverse event marking module is adapted to determine the identification code corresponding to each adverse event based on predefined labels.

6. The clinical trial data management system according to claim 1, characterized in that: The adverse event generating unit comprises: an adverse event generation template providing module, adapted to provide an event generation template, wherein the event generation template includes information for generating an adverse event; An adverse event filling module, adapted to fill in information for generating adverse events based on recorded adverse events; An adverse event generation module, adapted to generate the adverse event report file according to the event generation template and the filling information generated by the adverse event filling unit; Adverse event review module, suitable for reviewing and editing the content of adverse event report files; An adverse event transmission module is adapted to upload the reviewed and edited adverse event report files to the system or operator in a preset manner; Adverse event tracking module, suitable for recording the submission time and status of adverse event report documents, and tracking the processing progress of adverse event report documents; The adverse event archiving module is suitable for archiving and filing the adverse event report documents.

7. The clinical trial data management system according to claim 1, characterized in that: The adverse event analysis unit comprises: An adverse event summary module is adapted to collect and summarize adverse event data based on the adverse event report file, wherein the adverse event data includes: the total number, distribution, and severity of adverse events; The adverse event analysis module is adapted to determine the severity and distribution type of the adverse event based on the parameters of the adverse event data, and is adapted to conduct comparative analysis on each adverse event to determine the cause of occurrence and development trend of the adverse event.

8. The clinical trial data management system according to claim 1, characterized in that: The adverse event management unit includes: Adverse event monitoring plan module, suitable for formulating safety monitoring plans and providing monitoring indicators; An adverse event safety monitoring module, adapted to monitor safety events during the trial in real time according to the safety monitoring plan, wherein the safety events include the occurrence and severity of adverse events; Adverse event safety testing module, suitable for detecting safety monitoring signals corresponding to potential adverse events through data analysis and statistical methods, and verifying and confirming the safety monitoring signals; an adverse event safety management module, adapted to manage the event corresponding to the safety monitoring signal when determining that the event corresponding to the safety monitoring signal is an adverse event, and record the processing flow of the event corresponding to the safety monitoring signal; Adverse event safety supervision reporting module, suitable for generating safety supervision reports that meet regulatory requirements; The adverse event communication content storage module is suitable for storing adverse event coordination and communication information.

9. The clinical trial data management system according to any one of claims 1 to 8, characterized in that: Also includes: An adverse event feedback unit, adapted to generate a corresponding feedback report based on the analysis result of the adverse event analysis unit and the evaluation result of the adverse event evaluation unit; Adverse event marker unit, suitable for defining information of each adverse event.

10. A clinical trial data management method, characterized in that: include: When it is determined that the event corresponding to the acquired clinical trial data is consistent with the preset adverse event, the event corresponding to the clinical trial data is regarded as the adverse event; Classify and process the adverse events corresponding to the clinical trial data according to the type of the adverse event; According to the pre-set evaluation criteria, each adverse event is resolved and the priority of each adverse event is determined; Record each adverse event and determine the corresponding identification code for each adverse event; Generate adverse event report files corresponding to each adverse event based on the pre-set event generation template; Determine the severity, cause, and development trend of each adverse event based on each adverse event report document; Assess the association between each adverse event and the trial intervention, and relate each adverse event to subject information; Each adverse event is monitored and handled according to the pre-established safety monitoring plan.

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