Clinical Trial Master File Compliance

Duration: 75 Minutes
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.
Clinical Trial Master File Compliance
Instructor: Carolyn Troiano
Product ID: 507873
Objectives of the Presentation
  • Learn what content is required for a TMF for a clinical trial
  • Understand how the essential documents demonstrate the conduct of the regulated activities of the investigator and sponsor
  • Learn how to establish and maintain a well-organized TMF and provide quality assurance for the data included
  • Understand the importance of developing an effective Standard Operating Procedure (SOP) to support TMF activities
  • Learn the importance of developing a consistent system for locating TMF documents and preparing them for study team use or regulatory inspection
  • Learn about best practices and industry standards
Why Should you Attend
You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file. This webinar will also benefit those involved in the conduct of clinical trials, audit and inspection of clinical trial study data and records, and submission of filings to regulatory agencies that involve clinical trial data.

Areas Covered
  • 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
  • Q&A
Who will Benefit
Personnel in the following roles will benefit:
  • Information Technology (IT) Analysts
  • IT Developers
  • IT Support Staff
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Compliance Managers and Auditors
  • Lab Managers and Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders using Computer Systems regulated by FDA
  • Regulatory Affairs Personnel
  • Consultants in the Life Sciences and Tobacco Industries
  • Interns working at the companies listed above
  • College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements
Topic Background
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).

The TMF includes all of the documentation that a sponsor must record to demonstrate that they have met their obligations for the conduct of a clinical trial.

The Code of Federal Regulations states in 21 CFR 312.50:
"Sponsors are responsible for ensuring that the investigation(s) is/are conducted in accordance with the general investigational plan and protocols contained in the IND."
$200
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $250.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $300.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco 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.
View More