3 An 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: O A. Immediately, as it is not a safety assessment.

Case Studies In Health Information Management
3rd Edition
ISBN:9781337676908
Author:SCHNERING
Publisher:SCHNERING
Chapter1: Data Content, Structure, And Standards
Section: Chapter Questions
Problem 1.16.1C
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I need solve for questions 3 

All members serving on an IRB that oversees human research at an institution must be employed by or
affiliated with that institution.
O A. TRUE
O B. FALSE
An 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:
O A. Immediately, as it is not a safety assessment.
O B. Once the protocol is finalized and submitted to the FDA.
O C. Once the protocol and consent form updates are approved by the IRB.
O D. As soon as the study sponsor advises that their decision is final to remove these blood draws.
Transcribed Image Text:All members serving on an IRB that oversees human research at an institution must be employed by or affiliated with that institution. O A. TRUE O B. FALSE An 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: O A. Immediately, as it is not a safety assessment. O B. Once the protocol is finalized and submitted to the FDA. O C. Once the protocol and consent form updates are approved by the IRB. O D. As soon as the study sponsor advises that their decision is final to remove these blood draws.
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