SOCRA Certified Clinical Research Professional (CCRP) CCRP Question # 12 Topic 2 Discussion
CCRP Exam Topic 2 Question 12 Discussion:
Question #: 12
Topic #: 2
For an investigational new drug study that has potential side effects of myalgia, arthralgia, and lethargy, which of the following could serve as an acceptable consent statement?
A.
You might experience adverse events of myalgia, arthralgia, and lethargy
B.
You might have some muscle aches, joint pain, and tiredness
C.
You might develop symptoms of myalgia, arthralgia, and tiredness
D.
You might have some mild side effects while taking the investigational drug
Consent forms must present information inlanguage understandable to the subject, avoiding technical jargon.
21 CFR 50.20:“The information… shall be understandable to the subject… and not include any exculpatory language.”
ICH E6(R2) 4.8.6:Information should be presented inlanguage non-technical and understandable to the subject.
Thus, while medical terms (myalgia, arthralgia) are precise, they may not be understandable to laypersons. The correct format useslayman’s terms: “muscle aches, joint pain, and tiredness” (B).
Correct answer:B.
[References:, 21 CFR 50.20., ICH E6(R2), §4.8.6., ]
Contribute your Thoughts:
Chosen Answer:
This is a voting comment (?). You can switch to a simple comment. It is better to Upvote an existing comment if you don't have anything to add.
Submit