Poorly Defined Oversight Activities
Another common pitfall of TMFs is poorly defined requirements for conducting oversight of study activities. If the activities are not clearly defined and documented, it can be difficult to determine the compliance with this important activity. If you are conducting an audit for inspection, focus the audit on the most important aspects of managing the trial. As part of the audit, one should clearly define the audit scope and ensure that all aspects of the TMF are covered in the audit.
Suitability of Systems
Systems used to collect and store records in support of a clinical trial should be fit for purpose. For example, eTMF software used for managing the Trial Master File must have the necessary elements outlined in regulations to ensure data integrity. This includes the capability to provide an audit trail that shows actions taken, who performed them, when they were performed, and what changes were made. This allows inspectors to trace activities and monitor changes effectively.
Lack of Communication
Effective communication is vital when conducting a clinical trial. Lack of communication between teams, sponsors, CROs, and site personnel can lead to gaps in information collection and hinder effective inspections. Study Teams should establish clear lines of communication with all stakeholders, ensuring that all relevant information about the study is shared and discussed. Communication records including emails should be filed in the TMF to demonstrate transparency in activities and discussions. Relevant communications supporting study activities often occur through email Business rules should be established between teams (sponsor/CRO) to clearly identify the responsible party for filing emails, and when they should be filed. It is good practice to restrict your email thread to a single topic to make records easier to navigate. If additional discussion points are needed, initiate a new email.
Closing the Gap: Addressing Audit Findings
Once the TMF Audit is concluded, it is crucial to address any issues identified during the review. Even if the study teams disagree with certain findings. providing documentation that supports an alternative view or engaging in discussions with the auditor can help resolve differences. We often see that audit findings are not appropriately addressed, and important findings remain unresolved before inspection occurs. Closing the gap of understanding and addressing the issues found during an audit can support meaningful conversations with the inspectorate.
In conclusion, conducting a TMF audit is a critical step in maintaining the quality and integrity of clinical trial data and preparing for inspections. By carefully reviewing SOPs, evaluating TMF content quality, assessing oversight activities, ensuring training compliance, and interviewing study team members, organizations can enhance their inspection readiness. Avoiding common pitfalls such as incomplete or inaccurate documentation, poorly defined oversight activities, unsuitable systems, and lack of communication is essential. Finally, remembering to address the audit findings and resolving issues promptly can improve your chances of successful inspection.
If you have follow up questions regarding TMF Audits, we at Kivo are happy to help! Contact us at any time.