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

This course reviews the investigator TMF required and additional content for a clinical trial - the activities of set-up, maintenance, and quality control and assurance will be discussed, as well as common deficiencies and challenges.
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.

Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:

  • Clinical Research Manager
  • Clinical Research Coordinators
  • Clinical Research Associates
  • Clinical Trial Investigators
  • Administrative managers in charge of Clinical Research
  • Regulatory, Compliance Associates and Managers
  • Research Site Personnel involved in set-up and maintenance of any trial TMF
  • Quality Assurance of Research Sites
  • Research Site Personnel in Charge of Policy Development and Maintenance

For Registration:

Note: Use this promocode(117660) for 10% discount.