A regulatory remote verification portal system

Abstract

The application discloses a kind of supervisory remote check portal systems, belong to clinical trial supervision check field.The application includes: remote access module (L23), provides safe remote access portal for regulatory agency (FDA, EMA, NMPA);Data viewing module (L24), support real-time viewing source data (EDC / CRF / laboratory data), audit tracking record (data creation / modification / deletion record and operation time stamp / user), eTMF document (clinical trial scheme / informed consent / researcher manual / ethics batch piece);Access control module (L25), provide role-based access control, data access range isolation, operation permission control, IP white list;Log module (L26), record all operations;Evidence download module (L27), support downloading check evidence.The application realizes the safe compliance supervisory remote check, and check time is shortened from average 5 days to 1 day, and travel cost is reduced by 95%.

Description

Technical Field

[0001] This invention relates to the field of clinical trial regulatory verification technology, specifically to a system and method that provides a secure remote verification portal for regulatory agencies, supports real-time viewing of source data, audit trails, and eTMF documents, and supports remote regulatory verification. Background Technology

[0002] Regulatory agencies need to conduct on-site inspections of clinical trials, which is costly and time-consuming. Therefore, there is an urgent need for a secure and compliant remote regulatory inspection portal system. Summary of the Invention

[0003] To address the shortcomings of existing technologies, this invention proposes a remote monitoring and verification portal system and method.

[0004] Technical solution

[0005] To achieve the above objectives, the present invention adopts the following technical solution:

[0006] In a first aspect, the present invention provides a remote regulatory verification portal system, comprising:

[0007] The data acquisition interface (L21) is used to access source data, audit trails, and eTMF documents (L11, L12, L13).

[0008] The processing module is configured to perform the following operations:

[0009] • Provide a secure remote access portal for regulatory agencies (L23);

[0010] •Supports real-time viewing of source data (L24);

[0011] • Supports viewing audit trail records (L24);

[0012] • Supports viewing eTMF documentation (L24);

[0013] • Complete access control and operation logs (L25, L26);

[0014] • Support regulatory agencies in downloading verification evidence (L27);

[0015] The output module (L28) is used to output remote verification reports.

[0016] Secondly, the present invention provides a method for remote regulatory verification, including a login authentication step, a verification object selection step, a source data viewing step, an audit trail viewing step, an eTMF document viewing step, a question marking step, an evidence download step, and a report generation step.

[0017] Thirdly, the present invention provides a computer-readable storage medium having a computer program stored thereon, which, when executed by a processor, implements the steps of the above-described method.

[0018] Beneficial effects

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] 1. Supports remote regulatory verification, reducing costs;

[0021] 2. Secure access control to ensure data security;

[0022] 3. Complete operation logs that meet audit requirements;

[0023] 4. Supports evidence download, improving verification efficiency. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the system structure provided in an embodiment of the present invention. The diagram shows the composition and connection relationship of the data source layer (L1), the remote regulatory verification platform (L2), and the user terminal (L3).

[0025] Figure 2 This is a schematic diagram of access control and permission management provided in an embodiment of the present invention. The diagram shows user roles (R1), permission control (R2), and authentication methods (R3).

[0026] Figure 3 This is a flowchart of the remote verification process provided in an embodiment of the present invention. The flowchart shows the complete process from step 1 (S2) to step 11 (S12). Detailed Implementation

[0027] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments.

[0028] Example 1: System Structure

[0029] like Figure 1 As shown, this embodiment provides a remote regulatory verification portal system.

[0030] The data source layer (L1) includes:

[0031] • Source data (L11): EDC data, CRF data, laboratory data;

[0032] • Audit trail (L12): System operation log;

[0033] • eTMF documents (L13): Experimental documents, protocols, ICFs, etc.

[0034] The regulatory remote verification platform (L2) includes:

[0035] • Data acquisition interface (L21) is used to receive source data, audit trails, and eTMF documents;

[0036] • Preprocessing module (L22) is used for data desensitization and format standardization;

[0037] • The remote access module (L23) is configured to provide a secure remote access portal for regulatory agencies;

[0038] • The data viewing module (L24) is configured to support real-time viewing of source data, audit trails, and eTMF documents;

[0039] • The access control module (L25) is configured for full access control;

[0040] • The logging module (L26) is configured to record all operations;

[0041] • The evidence download module (L27) is configured to support regulatory agencies in downloading and verifying evidence;

[0042] • Output module (L28) is used to output remote verification reports.

[0043] The user side (L3) includes regulatory agencies (L31) (FDA, EMA, NMPA, etc.).

[0044] Example 2: Access Control and Permission Management

[0045] like Figure 2 As shown, this embodiment details the access control and permission management mechanism.

[0046] User roles (R1) include:

[0047] • Regulatory Inspector (R11): Viewing and downloading permissions;

[0048] • Sponsor Administrator (R12): Management and configuration permissions;

[0049] • System Auditor (R13): Audit privileges and log viewing.

[0050] Access control (R2) includes:

[0051] • Data access scope (R21): isolated by trial, center, and subject;

[0052] • Operation permissions (R22): View, download, export, print;

[0053] • Time range (R23): Restricts the time period for access;

[0054] • IP whitelist (R24): Restricts access to IP addresses.

[0055] Authentication methods (R3) include:

[0056] • Two-factor authentication (R31): Password + verification code;

[0057] • Digital Certificate (R32): PKI / CA Certificate;

[0058] • OAuth2.0 (R33): Third-party authentication.

[0059] Example 3: Remote Verification Method

[0060] like Figure 3 As shown, this embodiment details the complete process of remote verification.

[0061] Step 1 (S2): The regulatory agency logs in to perform identity authentication and permission verification.

[0062] Step 2 (S3): Select the verification target (trial, center, subject).

[0063] Step 3 (S4): View source data in real time (CRF, laboratory source data).

[0064] Step 4 (S5): Review the audit trail (data change history).

[0065] Step 5 (S6): Review the eTMF documentation (experimental documentation, protocol, ICF).

[0066] Step 6 (S7): Determine if any questions are found:

[0067] • If you have any questions, proceed to step 7;

[0068] • If there are no questions, proceed to step 8 to continue the verification.

[0069] Step 7 (S8): Mark the points of doubt and record the details of the questions.

[0070] Step 8 (S9): Continue to check other data, then return to step 3.

[0071] Step 9 (S10): Generate a list of questions, summarizing all questions.

[0072] Step 10 (S11): Download verification evidence (source data, audit trail, eTMF document).

[0073] Step 11 (S12): Generate a remote verification report.

[0074] Example 4: Clinical Validation

[0075] This embodiment verifies the technical effectiveness of the invention through a real-world regulatory inspection scenario. A remote regulatory inspection of a Phase III clinical trial was selected for verification.

[0076] The results show:

[0077] • Remote verification coverage reached 100%;

[0078] • Verification time has been reduced from an average of 5 days to 1 day;

[0079] • Travel costs reduced by 95%;

[0080] • Data security: No data breaches have occurred;

[0081] • Audit trail completeness rate 100%;

[0082] • Regulatory agency satisfaction rating: 9.3 / 10.

[0083] The clinical value of the system of the present invention in supporting remote regulatory verification and ensuring data security has been verified.

[0084] Industrial applicability

[0085] The system and method provided by this invention can be integrated into clinical trial data management platforms, eTMF systems, or regulatory submission platforms, and are applicable to CRO companies, pharmaceutical registration departments, and regulatory agencies, with broad industrial application prospects.

[0086] The above-described embodiments are merely preferred embodiments to fully illustrate the present invention, and the scope of protection of the present invention is not limited thereto. The scope of protection of the present invention is defined by the claims.

Claims

1. A remote regulatory verification portal system, characterized in that, include: The data acquisition interface (L21) is used to access source data, audit trails, and eTMF documents (L11, L12, L13). The processing module is configured to perform the following operations: • Provide a secure remote access portal for regulatory agencies (L23); •Supports real-time viewing of source data (L24); • Supports viewing audit trail records (L24); • Supports viewing eTMF documentation (L24); • Complete access control and operation logs (L25, L26); • Support regulatory agencies in downloading verification evidence (L27); The output module (L28) is used to output remote verification reports.

2. The system according to claim 1, characterized in that, The access control includes: • Role-based access control (regulatory inspector / sponsor administrator / system auditor); • Data access scope isolation (by trial / center / subject); • Access control (view / download / export / print); • Time limit; • IP whitelist restrictions.

3. The system according to claim 1, characterized in that, The authentication methods include: • Two-factor authentication (password + verification code); • Digital certificates (PKI / CA certificates); • OAuth2.0 third-party authentication.

4. The system according to claim 1, characterized in that, The source data includes: • Source data of the EDC system; •CRF form data; •Laboratory data; • Subject source files.

5. The system according to claim 1, characterized in that, The audit trail records include: • Data creation / modification / deletion of records; • Operation timestamp; • Operate users; • Values ​​before and after the operation; • Reason for operation.

6. The system according to claim 1, characterized in that, The eTMF document includes: • Clinical trial protocol; • Informed consent form; • Researcher's Handbook; • Ethical approval; • Contracts and agreements; • Monitoring report.

7. A method for remote regulatory verification, characterized in that, Includes the following steps: Step S2: The regulatory agency logs in to perform identity authentication and authorization verification; Step S3: Select the verification target (trial / center / subject); Step S4: View source data in real time (CRF / laboratory source data); Step S5: Review the audit trail (data change history); Step S6: Review the eTMF documentation (experimental documentation / protocol / ICF); Step S7: Determine if any questions are found; if so, mark the question points. Step S8: Continue to verify other data; Step S9: Generate a list of questions; Step S10: Download verification evidence (source data / audit trail / eTMF); Step S11: Generate a remote verification report.

8. A computer-readable storage medium having a computer program stored thereon, characterized in that, When the program is executed by the processor, it implements the steps of the method as described in claim 7.

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