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.

Answer 2

Since the investigator has decided to make changes to the study procedure, they must seek the approval of the IRB, which authorized the clinical trial in the first place.

The IRB (Institutional Review Board) remains the administrative agency that protects the rights and welfare of human research subjects. The board ensures that physical, psychological, legal, and social risks to human research subjects are minimal. Before approving any organization for human researches, it reviews the study procedures.

Thus, with a change in the study procedures, the right step is for the investigator to seek further approval for the changes.

Learn more about clinical trials and the IRB here: https://brainly.com/question/12958229