eTMF & GCP compliance

How Does an eTMF Contribute to Efficient Audits and GCP Compliance?

In the dynamic world of clinical research, adhering to Good Clinical Practice (GCP) guidelines and successfully navigating audits are ongoing challenges. How can you ensure that all study-related documents are meticulously maintained and that your operations remain compliant?

The electronic Trial Master File (eTMF) system supports universities, CROs, and hospitals in organizing and managing document workflows effectively. Beyond that, the system plays a crucial role in ensuring GCP compliance. With real-time access to documents, transparent workflows, and strict access controls, an eTMF enables research teams to work compliantly and stay audit-ready at all times.

6 Ways an eTMF System Simplifies Audits and GCP Compliance

1. Digital Availability of Documents

All documents are digitally stored and accessible via the eTMF system. Centralized storage in one location benefits both the research team and auditors, eliminating the need for endless document exchanges. Additionally, documents in an eTMF are well-organized according to a logical, predefined structure, often based on standard guidelines such as the DIA Reference Model. Lastly, the eTMF simplifies collaboration among research teams, especially when working from multiple locations.

Example:
An auditor can easily log into the eTMF and gain direct access to necessary study protocols, informed consent forms, IRB/EC approvals, the qualifications and certifications of the research team, and other essential documents for the audit.

2. Audit Trails

The eTMF tracks everything: every action is logged in an audit trail. This includes who accessed documents, what changes were made, when these changes occurred, and who approved them. This ensures complete traceability and transparency in verifying the integrity of the data. Based on these audit trails, teams can be held accountable for their actions, reducing the risk of errors (or fraud).

Example:
An auditor can easily see who made changes to a critical document and whether those changes were properly approved.

3. Document Status and Workflows Visible to Auditors

An eTMF provides insight into the status of every document within the system. This means that both the research team and auditors can see at any time what stage a particular document is in, such as “in progress,” “approved,” “rejected,” or “reminder sent to team member.” In the ResearchManager eTMF, an optional e-sign feature allows for quick and GCP-compliant document approvals. This transparency in status and workflow helps auditors quickly assess which documents are fully completed and which are still in progress, reducing the need to ask for document status updates, thereby making the audit faster and more efficient.

Example:
If an auditor needs to review all safety reports, they can instantly see whether they have been fully submitted and approved.

4. Access Management for Auditors

Access management is a critical aspect of the eTMF system. It ensures that auditors are granted access only to the documents they need to perform their work and nothing more. Restricted access prevents unauthorized changes and protects sensitive information, such as participants’ personal data and internal communications within the research team. The strict access control provided by an eTMF helps in complying with legal requirements and adhering to Good Clinical Practice guidelines.

Example:
An auditor is granted read-only rights to all relevant documents without the ability to make changes or access non-relevant data.

5. Auditors Have Access to Real-Time Information

One of the significant advantages of an electronic Trial Master File (eTMF) system is that auditors have access to the most up-to-date documents and data in real-time. This allows auditors to make quicker decisions and report their findings more efficiently. Any issues or deviations can be identified and addressed more promptly, contributing to the overall quality and integrity of the clinical trial.

Example:
During an audit, the auditor can immediately view the latest version of documents without waiting for an update from the research team.

6. Documents Are Easy to Find for Auditors

Documents can be organized by study phase, document type, location, or other relevant criteria, making them easy to locate. Additionally, documents are automatically indexed when uploaded to the system, facilitating the rapid retrieval of specific information. The ResearchManager eTMF includes a library feature that allows users to access the latest version of all documentation. Finally, an eTMF offers search functions that enable auditors to quickly find specific documents or information by using keywords, dates, or other metadata.

Example:
An auditor can swiftly locate all versions of a specific consent form by searching for keywords like “consent” and “version.”

But How Do You Know if an eTMF Itself Is Valid?

It’s not just clinical research that undergoes audits; eTMF systems are also subject to scrutiny. After all, you need to be confident that the eTMF is valid: Does it accurately measure and record what it’s supposed to? Are all changes in the system truly logged? Is everything included in the audit trail? And does it meet the highest security standards? At ResearchManager, we ensure continuous oversight of our eTMF system to guarantee its reliability, security, and validity.

The ResearchManager eTMF Is Also Continuously Tested for Validity

• Penetration Testing by Ethical Hackers

To demonstrate the security of our eTMF system, we engage ethical hackers to test it. Their goal is to identify any vulnerabilities that malicious hackers could exploit. By subjecting our eTMF system to these penetration tests, we can strengthen its security and mitigate potential threats.

• In-House Compliance Officer and Testers

ResearchManager employs a dedicated compliance officer and testers who ensure that all processes and systems comply with applicable laws and regulations. They conduct thorough checks to validate the system before any new release is rolled out. Additionally, users receive release documentation that can be provided to auditors upon request.

Conclusion: An eTMF Simplifies GCP Compliance and Audits

With direct and organized access to all necessary documents through an eTMF, auditors can perform their work much more efficiently. The less time spent searching for and organizing documents, the lower the audit costs. Additionally, the research team experiences fewer disruptions since document management is streamlined and changes to documents are automatically logged. Efficient audits help research teams at universities, CROs, and hospitals to meet regulatory requirements such as GCP guidelines more quickly, which is crucial for the progress of clinical studies.

Are you looking for a valid eTMF system you can rely on?

We’d be happy to show you how straightforward document management is with our eTMF. Before you know it, your research team and clinical study will be audit-ready.