Multiple choice general knowledge

According to ICH GCP what are the absolute minimum requirements for essential documents at site before IMP can be sent to the site

  1. CTA

  2. EC approval

  3. Signed protocol

  4. 1 and 2

  5. 1 and 3

  6. 1 , 2, 3

Reveal answer Fill a bubble to check yourself
D Correct answer
Explanation

According to ICH GCP guidelines, before an Investigational Medicinal Product (IMP) can be shipped to a site, the site must have both the Clinical Trial Agreement (CTA) and Ethics Committee (EC) approval. A signed protocol is important but CTA and EC approval are the minimum mandatory requirements.