Trial Master File for Research Sites: Can You Pass FDA Inspection?

This webinar on Trial Master File (TMF) for clinical research sites will show how you can create an FDA compliant TMF to ensure that it will pass inspection by FDA investigators and QA Auditors.

Why Should You Attend:

Your clinical trial has zero chance of passing an FDA inspection or QA audit if your Trial Master File (TMF) is not in order.

The FDA frequently states that if compliance isn't documented, it didn't happen. Your TMF serves as living proof that you are adhering to GCP, and that your quality system is in a state of control. Beyond simply being a get out of jail free card, a well-maintained TMF can make trial management easier; with a typical TMF containing thousands of pages of documentation, you could easily save, or lose, hundreds of hours over the life of a trial searching for individual pieces of knowledge.

Areas Covered in the Seminar:

• Documents that should, and should not, make up a Trial Master File.
• Maintenance and quality control of the TMF.
• Start smart—the steps to take from Day One to create a compliant and useful TMF.
• Red flags that scream "noncompliance".
• Common pain points that you can expect to encounter, and how to keep them from driving your TMF into noncompliance.
• Note to File (NTF).
• CRA contributions to and adequate monitoring of the investigator TMF.