Trial Master File (TMF): FDA Expectations from Sponsors and Sites

Duration: 60 Minutes
The first document FDA auditors review during the audit of a clinical site is the Trial Master File (TMF). The TMF is a collection of the essential documents to record a site has fulfilled its obligations to the sponsor regarding a clinical trial project.
Trial Master File Training
Instructor: Mukesh Kumar
Product ID: 500072
The regulations describe the various kinds of documentations that an investigator needs to maintain to demonstrate compliance. Sponsors are required to assure site compliance with the protocol tasks, training and provide any resources necessary to assist site’s ability to perform their tasks. The TMF not only acts as a warehouse for all the study-specific documents, but also acts a tool for quality control and quality assurance.

This webinar will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using case studies to highlight common deficiencies and potential solutions.

Why Should you Attend:
If you involved in a clinical trial, either as a clinical site or a sponsor, this seminar will provide valuable suggestions about which documents are essential and which ones are not needed for an FDA audit. Common deficiencies identified by FDA auditors during review of TMFs will be discussed with potential solutions to the same. Also discussed will be issues related to the kind of products being tested, responsibilities of individuals, resources available, and projected trends for the near future.

Objectives of the Presentation:
  • FDA’s expectation from site and sponsor’s documents
  • Required components of a TMF
  • Best practices for the set-up and maintenance of TMF
  • Electronic and Paper TMF requirements
  • Common errors in TMF management
Who can Benefit:
This webinar will provide valuable information to:
  • Clinical Research Associates (CRAs)
  • Clinical Research Coordinators (CRCs)
  • Clinical Research Administrators
  • Data Managers
  • Principal Investigators
  • Project Managers
  • Sponsors of INDs
  • People investing in FDA-regulated product development projects
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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