Halloran Consultant, Carmella Britt, presents a webinar, It’s Ten O’Clock. Do You Know Where Your Trial Master File Is?, in partnership with the
Halloran Consultant, Carmella Britt, presents a webinar, It’s Ten O’Clock. Do You Know Where Your Trial Master File Is?, in partnership with the Life Science Training Institute on March 10, 2015.
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
WHO SHOULD ATTEND
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.
Time: 1:00-2:30pm EDT
Date: March 10, 2015
Duration: 90 minutes
Place: Online Webinar
Price: $299 Introductory Rate
For more information and to register, please click here.
All Day (Tuesday)