Gain a recognized and traceable certificate after completing the course :
All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.
The Trial Master File (TMF) and the Investigator Site File (ISF) are important documents that contain the guidelines and information on the progression of a clinical trial from its initiation. These files are instrumental for monitoring and evaluation purposes along the trial timeline which helps to keep things in order. These files contain relevant documents that auditors, inspectors, and project evaluators would want to see when checking the trial for compliance with GCP among other requirements. This course introduces students to the types of these files and the situations where they are considered appropriate. You will also learn the best practices for each kind and whether both the TMF and ISF are necessary for every setting.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: Responsibilities and Procedures
Lesson 2: Contents for IMF and ISF
Lesson 3: Storage, Close Up of the Trial, and Archiving The TMF/ISF
Lesson 4: Security of TMF and ISF and Quality
Lesson 5: ISF Security, Quality, and Inspection
Lesson 6: Scanning or Transfers to Other Media