Set the Foundation for a Successful eTMF Implementation

To ensure a successful TMF implementation, build a strong internal team with executive support to prioritize TMF and inspection readiness. Identify key decision-makers and confirm the necessary expertise is available. For your external team, including eTMF vendors or CROs, ensure they understand and can meet your needs, align with your internal team, and establish clear points of contact. Finally, confirm all team members have proper eTMF access.

What does your vendor need to configure and launch your eTMF? After signing the contract, set a timeline. Decide if it’s for a single study or multiple studies, as this affects implementation length. Piloting with one study helps your team learn the system and refine your approach before scaling up.

Does each functional area understand their responsibilities? Ensure groups like data management know which documents they handle and why. Clarify ownership, document locations, and mapping if stored in other systems. Your plan should outline the TMF structure, chain of custody, and study-specific processes for archiving and paper destruction.

There are two ways you can use the TMF Reference Model: out-of-the-box or customized. Ask these questions to determine which is right for you: What do you need to go into a conversation with vendors? What will inspectors require of you for documentation? If you’re a sponsor, are there more documents you require?

How should documents be processed and submitted, and by whom? Discuss this with your study team and establish standard naming conventions to ensure proper filing, avoid duplicates, and enable quick retrieval. Include details like protocol number, site number, document type, and date. Educate users on these conventions and their importance for TMF submissions.