Management of The TMF and ISF

management tmf isf

Duration :


1 hour(s)

Skill level:




Final exam:


Certificate of Completion:


CEU / CPD Accreditation:



Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.


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.







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











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


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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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