Question

An investigator has received IRB approval for a clinical trial. During the course of the study, the investigator decides to make some changes to the study procedures to make management of the study easier for him and his study team. The investigator must what?

Answer 1

Answer:

The investigator must inform the administrative body or the Institutional review board about the changes made to the procedures of the study.

Explanation:

• To seek the approval of IRB for a clinical trial, the IRB requires the investigator to specify the procedure of the study that he is willing to carry out.
• The IRB permits the study if the procedure is feasible and fits within the norms set by laws.
• If any changes are to be made to the procedures during the course of the study, the chief investigator should inform IRB about the changes to maintain the legitimacy of the study.