It's Ten O'Clock. Do You Know Where Your Trial Master File Is?
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
This course will be of benefit to anyone involved in Trial Master Files a global or domestic scale. Clinical Development and Document Management personnel who are concerned about gaps in their Trial Master Files, particularly those that outsource all or part of their TMF maintenance to CROs, will find this course particularly beneficial.
Denise Lacey is a Principal Consultant at Halloran Consulting Group, Inc. She oversees the quality auditing business and also focuses on quality risk management techniques for clinical studies, including risk-based monitoring and vendor management. Denise has led multiple clinical development gap analyses and process development projects, including a number of quality system redesign initiatives.
Denise has over 15 years of experience in clinical development, providing consulting services to a wide range of pharmaceutical, medical device, biotech, and CRO clients in the US and Europe. Denise has worked with numerous companies to implement Electronic Data Capture (EDC), including process development, role development, and training, with a special emphasis on adapting monitoring practices to take advantage of EDC technology.
Prior to joining Halloran, Denise was Director of Clinical Planning and Performance at Vertex Pharmaceuticals, where her group coordinated planning activities, process development, and performance metrics among the clinical study team functions. She held project management positions at Searle (clinical project management) and Enmed (EDC). Prior to her work in clinical development, Denise was a teacher of English language and literature at the secondary and university levels, including three years in Tunisia as a member of the United States Peace Corps.
Denise holds a Master of Science from the University of Pennsylvania, a Master of Arts from Villanova University, and a Bachelor of Arts from Dickinson College.