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

Duration : 60 Minutes

Carolyn Troiano,

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. Du Read more

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

Course Objectives:

This webinar is very much essential for Professionals involved in a clinical trials, either as a clinical site or a sponsor/CRO as it will provide valuable suggestions about which documents are essential according to FDA requirements for drugs, biologics and medical devices. The instructor will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions and best practices of implementation related to set up, maintenance and quality control of the TMF for drugs, biologics and medical devices.

Course Outline:

• FDA’s expectation for clinical site and sponsor’s essential regulatory documents
• Required components of a TMF
• Best practices for the set-up and maintenance of TMF
• Electronic and Paper TMF requirements
• Common discrepancies in TMF management

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Clinical Research Associates (CRAs)
• Clinical Research Coordinators (CRCs)
• Clinical Research Administrators
• Principal Investigators
• Project Managers
• Sponsors of INDs

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


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

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