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