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.
Carmella Britt has preclinical and clinical experience in both academic and industry settings and a therapeutic background in cardiology and oncology, with a focus on clinical development and operations. At Halloran Consulting, she focuses on providing strategic clinical support, as well as trial master file management, and trial metric development and tracking.
Carmella also specializes in providing regulatory and organizational strategy support, process improvement, inspection readiness support, and integration and harmonization of Standard Operating Procedures for medical device and pharmaceutical companies.
Prior to joining Halloran, Carmella held research positions at Dana Farber Cancer Institute and Children’s Hospital Boston. Most recently, she was a CRA at Thoratec Corporation, and a Clinical Research Coordinator at Massachusetts General Hospital (MGH), in the Cardiac Resynchronization Program (CRT) Program. While at Thoratec, Carmella managed clinical sites for post market studies, with responsibilities that included regulatory document compliance, study initiation, monitoring, patient recruitment strategies, and maintenance of project files to optimize clinical trial performance.
Carmella earned a Master in Public Health from Emory University and a Bachelor of Arts from Wellesley College.