Management of The TMF and ISF

The Trial Master File (TMF) and the Investigator Site File (ISF) are important documents. They 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.

They include 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.

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.

Curriculum

Introduction

Lesson 1: Responsibilities and Procedures

• Trial Master File (TMF)
• Investigator’s Site File (ISF)
• Requirements for the eTMF

Lesson 2: Contents for IMF and ISF

• Before the Initiation of the Study
• During the Experimentation

Lesson 3: Storage, Close Up of the Trial, and Archiving The TMF/ISF

• Storage
• Close-out of the Trial
• Archiving the TMF/ISF

Lesson 4: Security of TMF and ISF and Quality

• Security for eTMFs

Lesson 5: ISF Security, Quality, and Inspection

• Security
• Quality of TMF
• Inspection of TMF

Lesson 6: Scanning or Transfers to Other Media

• Certified Copies
• Other Copies
• Validation of The Digitalization and Transfer Process
• Destruction of Original Documents After Digitalization and Transfer

Glossary

Definitions

Conclusion

Quiz