From The Editor | June 28, 2024

Insights Into TMF Challenges & Solutions — Part 2


By Dan Schell, Chief Editor, Clinical Leader

Nicole Palmer circle and apple headshot
Nicole Palmer

Nicole Palmer worked her way up the ranks from being an administrative assistant at a CRO to eventually a clinical trial administrator/manager with a lot of expertise on the trial master file. In part 2 of this two-part Q&A, Palmer, CEO and president of consulting firm Granular Level, gives some good career advice for TMF professionals and talks about TMF audits and the EU’s Clinical Trials Information System (CTIS).

In your video with Karen Roy, she talks about TMF-related initiatives such as the one with Transcelerate. If I’m involved with the TMF, what associations or industry initiatives like this should I be tracking to stay up to date on the most current changes or updates to the TMF?

NP: To stay up to date with the latest changes in the TMF I think it’s important to follow, TransCelerate BioPharma, DIA (Drug Information Association), CDISC (Clinical Data Interchange Standards Consortium), MHRA  (Medicines and Healthcare Products Regulatory Agency), FDA, as well as ICH-GCP (International Council for Harmonisation and Good Clinical Practice). Here’s why; keeping up with the latest changes, best practices, and regulatory requirements will solidify your reputation as a “Trial Master File expert” and show that you are proactive and know how to take initiative in being compliant, which in turn will contribute to your TMF being inspection-ready at all times.

What are some tips for preparing for a GCP audit of the TMF?

NP: There’s often confusion around TMF inspection vs TMF audit. ICH-GCP E6 R2 1.6 defines audits as, “A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard SOPs, GCP, and the applicable regulatory requirement(s).”

Preparing for a GCP TMF audit may sound overwhelming but with the right attitude and perspective it can be fun!Remind yourself that we all have a common goal here and that is to do great work. Having the mindset that we are on the same team can make all the difference. So, when we find a mistake it’s not about pointing fingers, it’s about “How are we going to solve this problem?”

First, I think it’s important to understand the goal of the audit. An auditor will be looking at your processes and ensuring that you are following your SOPs and that you’re following all of the regulatory requirements. It’s important that your TMF is up to date, accurate, and that it is easy to find documentation. Has your GCP training expired? Do you need to take a refresher course? If you are using an eTMF, who will be responsible for giving auditor access? These are just some examples to get your brain thinking like an auditor.

How will the CTIS impact TMF managers?

NP: The CTIS has changed how we manage the TMF in terms of requirements and workflows. First, you need to be trained on the system, confidentiality, and data protection. Second, you need to familiarize yourself with which documents will need to be submitted through the system and if they are formatted and in compliance within the CTIS system. Since these documents are made available to the public, they will need to be properly redacted. TMF managers, ultimately, need to ensure their TMF management processes are in alignment with the requirements of the CTIS.