SOCRA Certified Clinical Research Professional (CCRP) CCRP Question # 4 Topic 1 Discussion
CCRP Exam Topic 1 Question 4 Discussion:
Question #: 4
Topic #: 1
A study coordinator is developing an informed consent form for the first time. As per the CFR and ICH GCP Guideline, which of the following elements must be included?
A.
An explanation of the person to contact at the sponsor for further information regarding research subjects’ rights
B.
A note that the qualified investigator could be financially compensated by the sponsor to conduct the clinical trial
C.
A statement confirming that the subject has received a copy of the signed consent document
D.
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
Theinformed consent processmust include all basic elements listed in federal regulations.
21 CFR 50.25(a)(4):Requires “a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.”
ICH E6(R2) 4.8.10(c):Mirrors this, requiring subjects to be informed of alternatives to participation, including available standard treatments.
This ensures the ethical principle ofRespect for Persons(Belmont Report), giving subjects the autonomy to choose among reasonable medical options.
Incorrect options:
A: Contact information must be provided, but it is for the investigator (or IRB), not sponsor.
B: Financial disclosures may be required for IRB review, not subject-facing.
C: Subjects do receive a copy, but it is not a required consentelementin regulations.
Correct answer:D.
[References:, 21 CFR 50.25(a)(4)., ICH E6(R2), §4.8.10(c)., ]
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