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Mapping the Future for Trial Master File: Advancing Standards by Harmonizing Clinical and Technical Strengths
Session Chair(s)
Donna Dorozinsky, BSN, MSN
President & CEO
Just in Time GCP, United States
Standardization has become the norm across the clinical research spectrum. The industry has embraced data standards,such as MEDRA, CDISC, and eCTD. The Trial Master File (TMF) is a collection of content that demonstrates that the sponsor conducted the study in accordance with the protocol and Good Clinical Practice. In the past several years there has been an industry move to creating best practice and standardizing the Trial Master File content. Standardized TMF content ensures completeness of regulatory submission, regulatory inspection readiness and trial execution. The TMF standards are evolving to address the interoperability needs of collaboration, mergers, acquisitions, licensing efforts and records retention. This session will discuss the importance of standards in TMF and explore the currently available standards within the industry.
Learning Objective : Describe the most recent versions of the Trial Master File (TMF) Reference Model and OASIS eTMF standards; Identify opportunities for application of TMF standards within the clinical trial environment.
Speaker(s)
Achieve Synergy Between Clinical and Technical TMF Standard With These Simple Steps
Donna Dorozinsky, BSN, MSN
Just in Time GCP, United States
President & CEO
Think Standard Inventory Means Technical Interoperability? Think Again
Michael Agard, MS, RPh
NNIT, United States
Director Clinical Consulting US
Just The Facts
Eric Rubinson
CGI, United States
Director, Consulting Services