Phlebotomy Essentials
Phlebotomy Essentials
6th Edition
ISBN: 9781451194524
Author: Ruth McCall, Cathee M. Tankersley MT(ASCP)
Publisher: JONES+BARTLETT PUBLISHERS, INC.
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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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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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