1.

What Are The Contents Of A Clinical Trial Protocol?

Answer»

According to the ICH GCP, the following INFORMATION is to be INCLUDED in a protocol:

  1. Protocol title 
  2. Name and address of Sponsor and MONITOR
  3. Name of authorized person
  4. Name of Sponsor’s medical expert
  5. Name of Investigator responsible for the trial
  6. Name of PHYSICIAN responsible for trial - related medical decisions
  7. Name of clinical laboratory and other institutions involved in the trial
  8. Name and DESCRIPTION of the clinical trial protocol
  9. Summary of results from nonclinical studies
  10. Potential risks and benefits to human subjects
  11. Description and justification for route of administration, dosage, and treatment plan
  12. Compliance to GCP
  13. Description of the population to be studied
  14. Reference literature and related data
  15. Standard operating procedures

According to the ICH GCP, the following information is to be included in a protocol:


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