Ensuring Compliance in eTMF Archival

 
Adherence to regulatory standards is non-negotiable in Clinical Research. In the archival world, there is growing emphasis on achieving compliance. This blog serves as a guide for navigating compliance requirements in eTMF archival, leveraging insights from regulatory directives and best practices to fortify clinical trial integrity.
 
Regulatory Guidance and Compliance Standards:
 

1. US FDA 36905975dftrv1 III.A: Records needed for FDA to reconstruct a clinical investigation that are maintained and archived under predicate rules in electronic format in place of paper format or where the electronic record is relied on to perform regulated activities.
2. US FDA 36905975dftrv1 Q6: There are various ways to retain electronic records, including in durable electronic storage devices and using cloud computing services. Sponsors, clinical investigators, and other regulated entities must ensure the authenticity, integrity, and confidentiality of the data from the point of creation and also ensure that the meaning of the record is preserved. The relationship between records, source data, and all associated metadata should be preserved in a secure and traceable manner.
3. ICH-GCP E6(R3) C.2.6: The sponsor and investigator/institution should retain the essential records in a way that ensures that they remain complete, readable and readily available and are directly accessible upon request by regulatory authorities. Alteration to the essential records should be traceable.
4. EMA EMA/INS/GCP/856758/2018 6.0: Articles 58 and 57 of the Regulation, both state that “the content of the clinical TMF shall be archived in a way that ensures that it is readily available and directly accessible, upon request, to the Member States.” Article 58 of the Regulation and Article 20 of Directive 2005/28/EC, also state that “any alteration to the content of the clinical trial master file shall be traceable”
5. EMA EMA/INS/GCP/856758/2018 6.1: The sponsor’s TMF may be transferred to a CRO for archiving (e.g. an external archive), but the ultimate responsibility for the quality, integrity, confidentiality and retrieval of the documents resides with the sponsor.

 
Importance of Compliance in eTMF Archival:
 

1. Regulatory Alignment: Compliance with regulatory standards ensures alignment with FDA, ICH, and EMA requirements, reducing the risk of findings or non-compliance during regulatory inspections and audits. By adhering to regulatory directives, sponsors demonstrate their commitment to data integrity, patient safety, and ethical conduct in clinical research.
2. Data Integrity Assurance: Compliance-driven eTMF archival practices enhance data integrity, reliability, and traceability throughout the trial lifecycle. By maintaining complete, accurate, and auditable trial documentation, sponsors mitigate the risk of data loss, corruption, or tampering, preserving the credibility and validity of research findings.
3. Risk Mitigation: Proactive compliance measures minimize the risk of compliance breaches, regulatory sanctions, and reputational damage. By implementing robust eTMF archival practices and adhering to regulatory guidelines, sponsors mitigate risks associated with non-compliance, ensuring continuity and success in clinical trial operations.

 
Best Practices for Compliance in eTMF Archival:
 

1. Document Management: Implement a systematic approach to document management, including standardized naming conventions, file structures, and version control mechanisms. Ensure that eTMF content is organized, indexed, and accessible in accordance with regulatory requirements to facilitate inspection readiness and auditability.
2. Quality Assurance: Establish robust quality assurance processes to verify the completeness, accuracy, and integrity of eTMF content. Conduct regular audits, reconciliations, and quality checks to identify discrepancies or deviations from predefined standards. Address any compliance issues promptly to mitigate risks and maintain regulatory compliance.
3. Data Security: Prioritize data security measures to safeguard eTMF content from unauthorized access, manipulation, or loss. Implement encryption, access controls, and audit trails to protect sensitive trial information and ensure compliance with data protection regulations such as the EU General Data Protection Regulation (GDPR).
4. Training and Education: Provide comprehensive training to trial personnel on eTMF archival procedures, regulatory requirements, and compliance obligations. Foster a culture of compliance and accountability within the organization, emphasizing the importance of adhering to established archival practices and regulatory guidelines.

 
Compliance in eTMF archival is essential for maintaining regulatory alignment, data integrity, and risk mitigation in clinical trials. By adhering to regulatory directives, implementing best practices, and prioritizing compliance-driven approaches, sponsors can fortify the integrity of trial documentation, enhance regulatory readiness, and advance the standards of clinical research conduct.

CLIN STREET’s eTMF platform offers a comprehensive suite of features designed to ensure best in class eTMF Archival and streamline management, all from a single location. Key features include:

1. Comprehensive Document Tracking : Compliance driving feature of creating list of documents based on source TMF and tracking further progress per document till archival.
2. Archival Stage Confirmations : Dedicated view for Archival managers to review progress of Archival per archival stage, allowing quality driven decision making.
3. Audit Trail : Track of every activity right from Study creation till Archival confirmation in the audit trail ensuring compliance, integrity and quality of system.
4. Instant Access : Ability to provide access to users instantaneously for archived TMF documents.
5. Reconstruct of Trial : First class solution offering ability to review quality of archived documents using audit trails that are generated outside of CLIN STREET eTMF prior to archival.
6. Metadata Mapping : Automated mapping of metadata with archived documents that are generated outside of CLIN STREET eTMF prior to archival, ensuring integrity.
7. Archival Compliance Verification : System driven alerts driving compliance for open tasks associated with TMF, driving overall quality compliance of the TMF.
8. Preserving Structure : Preservation of TMF Structure that was in effect during course of the trial, ensuring compliance.
9. Source TMF Audit Trail : Tailored feature supporting migration of audit trail per document and system, keeping entire lifecycle of document accessible.

 
We understand that achieving Compliance in TMF Archival can be delicate and your needs are unique. That’s why we’re here to offer a tailor-made walkthrough of our CLIN STREET eTMF platform, designed to simplify and enhance your clinical trial management process. Let’s explore together how our solutions can be precisely aligned with your project’s requirements by scheduling a personalized demonstration here. Alternatively, you can also contact us at hello@clinstreet.com. Our team is available around the clock to accommodate your schedule and provide the support you need

About the Author: Shounak Damle is a seasoned clinical trial professional with extensive experience in TMF management and other eClinical technologies. With a passion for quality assurance and compliance.