GXP0276 Management of The TMF and ISF

GXP0276 Management of The TMF and ISF

Description:

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.

 

 

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

 

Author:

GXP0276 Management of The TMF and ISF
Dr. Masaab Bashir
Dr. Massab Bashir holds a Ph.D. in Microbiology and Immunology. Dr. Bashir leads a medical and research writing team of qualified doctors. Massab and his team have over five years of research writing experience in the medical, biotech, and pharmaceutical fields. To date, Dr. Bashir and his team have successfully completed more than 500 projects

General info:

Duration:

1 hour

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

Reviews:

Documentation that makes it possible for a clinical trial to be repeated and provide comparable results is necessary. My team has learned that if documentation is this important in research, it must be taken seriously in manufacturing too.

Regina C

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Training Director

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GXP0276 Management of The TMF and ISF

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