Webinar Recap: TMF Quality Assurance and Auditing Practices
Webinar Recap: TMF Quality Assurance and Auditing Practices
In our Ensuring Excellence: TMF Quality Assurance and Auditing Practices webinar, Janice Del Rosario, Director of TMF Services at LMK Clinical Research, and Ruby Scott, Associate Director of TMF Services experienced – industry professional, led an insightful discussion on TMF quality assurance and auditing best practices. With nearly 40 years of combined experience, Janice and Ruby provided a wealth of expertise on maintaining a compliant, inspection-ready TMF that tells the story of clinical trials effectively.
Key Topics and Takeaways
Understanding Audits vs. Inspections:
Audits are internal or third-party reviews, whereas inspections are conducted by regulatory agencies like the FDA. Knowing who is performing the review is essential, as each carries different implications for compliance and readiness.
Janice and Ruby clarified that audits could be external (by third parties) or internal (quality assurance teams), both of which are crucial in ensuring TMF integrity.
Preparation for Audits:
Being inspection-ready at all times is the best approach, focusing on real-time, contemporaneous document filing and regular checks.
Risk-based preparation is essential, prioritizing high-risk areas and working closely with QA to identify “hotspots” in the TMF.
Both Janice and Ruby emphasized that the goal is to prevent the need for last-minute scrambling, which disrupts workflows and increases stress.
Developing an Effective Audit SOP:
Janice advised that SOPs should offer clear but flexible guidelines, avoiding overly rigid prescriptions to allow for real-world variability. This balance ensures that SOPs are practical, guiding routine actions without necessitating frequent deviations.
Ruby recommended defining responsibilities and roles clearly to streamline audit preparation, helping to prevent overlaps or gaps in oversight.
Inspection Trends and Key Focus Areas:
Recent trends from the FDA have highlighted vendor oversight and adherence to ICH E6 (R2 and R3) guidelines. There’s increased scrutiny on maintaining thorough documentation on both sponsor and CRO responsibilities.
Qualifications documents, planning documents, and real-time TMF updates are also common focal points in inspections. Failure to meet these standards can signal larger compliance issues and lead to critical findings.
Consequences of Not Being Inspection Ready:
Failing to maintain an inspection-ready TMF can have serious consequences, including regulatory findings (483 observations), delayed drug approvals, and reputational damage.
Janice and Ruby underscored that non-compliance can lead to costly rework and lowered team morale. They advised cultivating good habits around document submission and regular audits as part of daily workflows, helping ensure a smooth inspection process.
Establishing Core TMF KPIs:
They recommended focusing on core KPIs for TMF completeness, quality, and timeliness. These metrics ensure transparency and efficiency, crucial for both sponsors and CROs. Customizing KPIs to the organization’s risk-based priorities can help maintain an audit-ready TMF consistently.
Final Thoughts
The session underscored that the secret to successful TMF management lies in consistency, compliance, and teamwork. By building a culture of continuous improvement and staying prepared, teams can avoid the pitfalls of last-minute compliance rushes and strengthen their documentation practices.
We thank everyone who participated in this engaging webinar and look forward to future sessions to continue the conversation on TMF best practices. For more insights – join us for our next interactive webinar featuring Jennifer Langelier and Ben Rogers on November 19th at 11 AM. This session will dive into TMF planning and setup best practices, focusing on creating a solid foundation for successful trial management. Attendees will learn key strategies to streamline the TMF process from the start.