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DIA and SureClinical Webinar to Explain New Electronic Master File (eTMF) Data Standards

Found in: Article, CMC, Clinical Safety & Pharmacovigilance, Clinical Development & Operations, Clinical Supplies
DIA in cooperation with SureClinical will host a complimentary webinar "How New Electronic Trial Master File (eTMF) Data Standards Can Enhance Clinical Trial Efficiency and Quality" on October 28 from 11 a.m. to 12:15 p.m. EDT.

In addition to SureClinical, speakers from the National Cancer Institute (NCI), ACT Oncology and CareLex will discuss the importance of data standards in clinical trials, and how the new OASIS eTMF Standard is being applied in clinical trials.

“The draft OASIS eTMF Standard builds on the great work that was started in DIA’s Document and Records Management Community and helps to promote a truly global interoperable data standard,” said Susan Cantrell, Sr. VP and Managing Director, DIA Americas. “We welcome the National Cancer Institute’s involvement in this important industry initiative.”

"The OASIS eTMF Standard Technical Committee is proud to build on the work of the DIA’s Document and Records Management Community and to coordinate with BioPharma stakeholders and regulatory agencies worldwide on this interoperable standard for the clinical trials area," said Laurent Liscia, executive director and CEO of OASIS, the global standards organization, regarding the importance of this work.

An overview of the draft OASIS eTMF Standard will be presented, including details on how organizations can benefit by using the eTMF controlled vocabulary terms hosted by the National Cancer Institute (NCI). Attendees will learn how the eTMF Standard and NCI’s term database will help improve data consistency and data portability between organizations involved in clinical trials. Industry experts will share criteria for selecting an eTMF solution and the business benefits of data standards. The webinar will feature:
  • Margaret W. Haber, RN, Program Manager, National Cancer Institute Enterprise Vocabulary Services
  • Rob Ott, MBA, Executive Director, ACT Oncology
  • Jennifer Alpert Palchak, CEO CareLex; Co-Chair OASIS eTMF Standard Technical Committee
  • Zack Schmidt, CEO SureClinical; Co-Chair OASIS eTMF Standard Technical Committee
  • Lou Chappuie, COO, SureClinical; Member, OASIS eTMF Standard Technical Committee

Register for the DIA eTMF Webinar