Trial Master File for Research Sites: Can You Pass FDA Inspection? (Clinical Compliance )
Venue: Online Event
|Event Date/Time: Jul 22, 2011|
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 smartâ€”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.
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