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. 4. If already serving as a member of the IRB, a clinical investigator can participate in the review of her own clinical protocol.

Comprehensive Medical Terminology
4th Edition
ISBN:9781133478850
Author:Jones
Publisher:Jones
Chapter22: Pharmacology
Section: Chapter Questions
Problem B8CRE
icon
Related questions
Question
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.
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.
If already serving as a member of the IRB, a clinical investigator can participate in the review of her
own clinical protocol.
O A. TRUE
O B. FALSE
An IRB may perform an expedited review of a protocol or informed consent form change if the change
involves no more than minimal risk to study participants.
O A. TRUE
O B. FALSE
Transcribed Image Text: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. 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. If already serving as a member of the IRB, a clinical investigator can participate in the review of her own clinical protocol. O A. TRUE O B. FALSE An IRB may perform an expedited review of a protocol or informed consent form change if the change involves no more than minimal risk to study participants. O A. TRUE O B. FALSE
Expert Solution
trending now

Trending now

This is a popular solution!

steps

Step by step

Solved in 8 steps

Blurred answer
Knowledge Booster
Violence
Learn more about
Need a deep-dive on the concept behind this application? Look no further. Learn more about this topic, biology and related others by exploring similar questions and additional content below.
Similar questions
  • SEE MORE QUESTIONS
Recommended textbooks for you
Comprehensive Medical Terminology
Comprehensive Medical Terminology
Nursing
ISBN:
9781133478850
Author:
Jones
Publisher:
Cengage
3-2-1 Code It
3-2-1 Code It
Biology
ISBN:
9781337660549
Author:
GREEN
Publisher:
Cengage
Comprehensive Medical Assisting: Administrative a…
Comprehensive Medical Assisting: Administrative a…
Nursing
ISBN:
9781305964792
Author:
Wilburta Q. Lindh, Carol D. Tamparo, Barbara M. Dahl, Julie Morris, Cindy Correa
Publisher:
Cengage Learning
Case Studies In Health Information Management
Case Studies In Health Information Management
Biology
ISBN:
9781337676908
Author:
SCHNERING
Publisher:
Cengage
Understanding Health Insurance: A Guide to Billin…
Understanding Health Insurance: A Guide to Billin…
Health & Nutrition
ISBN:
9781337679480
Author:
GREEN
Publisher:
Cengage
Biomedical Instrumentation Systems
Biomedical Instrumentation Systems
Chemistry
ISBN:
9781133478294
Author:
Chatterjee
Publisher:
Cengage