It’s ten o’clock. Do you know where your Trial Master File is?
“Oh, the CRO is keeping an eye on it,” you sigh with relief. But TMFs these days run a little wilder than they used to. It’s not just “essential documents” anymore. We’re talking contracts and vendor oversight documents. Statistical deliverables and EDC exports. What is a “document,” anyway? You’ve got electronic documents, paper documents, electronic scans of paper documents. E-signatures and wet signatures. You can’t even tell an original document from a copy anymore.
Are you sure the CRO has the whole thing under control? Have you even had “the talk” with them yet – the one where you figure out which documents they will be transferring back to you, when, and how?
This session is aimed at sponsors who want to bring some discipline back to their TMF and at CROs and other vendors who want to partner effectively with them. We’ll cover industry standards for content; document handling for electronic/paper hybrids; best practices for corralling TMFs dispersed across multiple vendors; and techniques for ensuring that substantive issues are well-documented.
By the end of the session, participants will be able to:
- Understand the purpose and extent of the Trial Master File – and how to best manage it
- Understand how 21 CFR Part 11 governs repositories that hold electronic documents
- Implement best practices for outsourced studies to avoid duplication and guarantee coverage
- Use “storyboarding” to ensure substantive issues are documented in the Trial Master File