Trial Master File (TMF): FDA Expectations from Sponsors and Sites
Date: April 9, 2025
Duration: 60 Minutes
Time: 12 PM EST
The Trial Master File (TMF) is an extremely important document because this is what the FDA auditors first review during the audit of a clinical site. The TMF is a collection of the essential documents to record that site has fulfilled its obligations to the sponsor regarding a clinical trial project. For an investigator to demonstrate compliance, one needs to maintain various kinds of documentations that the regulations describe. 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 are 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.
Topics covered in the Session:
- 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
- FDA Trial Master File Guidance and Requirements
Who will 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
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
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Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
