Question

4An ongoing clinical protocol at your site includes weekly blood draws to assess an exploratory endpoint. Unfortunately, participants are not happy about visiting the clinic weekly, and they are considering dropping out. Therefore, a protocol amendment is being prepared to remove the weekly blood draw. This change can be implemented:
A. Immediately, as it is not a safety assessment.
B. Once the protocol is finalized and submitted to the FDA.
C. Once the protocol and consent form updates are approved by the IRB.
D. As soon as the study sponsor advises that their decision is final to remove these blood draws.

Answer 1

Answer:

correct option B

Explanation:

Once the protocol is finalized and submitted to the FDA.

Answer 2

Option B is the correct answer to this question.

• In the event of a medical emergency the health status of the participant is to unbliad allocation status to determine the specific treatment.
• The clinical researcher should contact the principal investigator of the medical emergency as soon as possible after the event.
• The unblinded project will provide the participant's treatment to the study team unless deemed necessary.
• All cases of unlined must be documented, and keep all information related to the individual confidential.