Trial Master File and Clinical Data Management Regulated by FDA

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.

Live Online Training
July 25, Thursday 10:00 AM PT | 01:00 PM ET (60 Min)

$199.00
One Dial-in One Attendee
$999.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Recorded Version Only

(PPT + Recorded Streaming Link)

$249.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section 48 hrs after completion of Live training

Download File Only

(PPT + Recorded Training File)

$349.00
Downloadable file is for usage in one location only.
(For multiple locations contact Customer Care)
Downloadable link along with the materials will be emailed within 2 business days after completion of Live training
Customer Care

Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

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Why Should You Attend:

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).

This webinar will help you understand in detail the new requirements for trial master files (TMF).

Areas Covered in the Webinar:
  • Trial Master File (TMF) background and rationale
  • The essential documents to include in a TMF
  • Organizing and maintaining a TMF
  • Standard Operating Procedure required to support TMF
  • Inspection of TMF records
Who Will Benefit:
  • Lead CRAs
  • CRA Managers
  • Project and/or Study Managers
  • Project and/or Clinical Trial Assistants
  • Clinical Operations Administrators
  • Quality Assurance Personnel
  • Auditors
  • Sponsor and CRO personnel involved in set up, maintenance, and auditing of the Trial Master File for sponsors
  • Consultants working in the life science, tobacco and related industries who are involved in computer system implementation, validation and compliance
Instructor Profile:
Carolyn Troiano Carolyn Troiano

ERP Project Manager, City of Richmond

Carolyn Troiano has more than 30 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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