Multiple choice general knowledge

According to ICH GCP, where should ORIGINAL completed CRF pages be filed?

  1. In the sponsor files

  2. In the investigator site files

  3. Either the sponsor file or the site file is OK as long as it is stated in the protocol

  4. The ICH-GCP doesnot specify
Reveal answer Fill a bubble to check yourself
A Correct answer
Explanation

According to ICH GCP guidelines, original completed Case Report Form (CRF) pages should be filed in the sponsor's files. The investigator site may retain copies but the originals must go to the sponsor who is responsible for maintaining the complete trial documentation and ensuring data integrity.

Keep practicing — related questions