Trial Master File for Research Sites: Can You Pass FDA Inspection? (Clinical Compliance )

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Jul 22, 2011
Report as Spam


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.

In this webinar, you will get guidance on the TMF. Learn the steps to take throughout a trial to ensure your TMF will pass inspection by FDA investigators and QA auditors.

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.

Note :Add another webinar to your shopping cart and get 20% off on its price.


Online Event
2600 E. Bayshore Road
Palo Alto
United States