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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q64-Q69):

NEW QUESTION # 64
In accordance with the ICH GCP Guideline, which of the following should the investigator refer to when a subject returns unused medication at the completion of a study?

A. The Investigator's Brochure
B. The sponsor's written procedures
C. The CRO/site agreements
D. The investigational pharmacy's requirements

Answer: B

Explanation:
Handling of investigational product (IP), including returns, is governed bysponsor's written procedures.
* ICH E6(R2) 4.6.3:"The investigator/institution should maintain records of the product's delivery, the inventory, the use by each subject, and the return to the sponsor or alternative disposition."
* ICH E6(R2) 5.13.3:"The sponsor should ensure that written procedures include instructions for... the return or alternative disposition of unused product(s)." The IB (A) describes pharmacology and safety, not IP logistics. CRO agreements (C) cover contractual duties, not product return processes. Local pharmacy policies (D) may apply operationally but do not override sponsor-required procedures.
Thus, the correct answer isB (The sponsor's written procedures).
References:
ICH E6(R2), §4.6.3 (Investigator product accountability).
ICH E6(R2), §5.13.3 (Sponsor product return procedures).

NEW QUESTION # 65
For a Significant Risk device study, an investigator must report within 5 working days which event?

A. Unanticipated adverse effect
B. Completion of investigation
C. Withdrawal of FDA approval
D. Emergency deviation

Answer: D

Explanation:
* 21 CFR 812.150(a)(4):Any deviation from investigational plan made to protect the life or physical well- being of a subject in an emergency must be reported to the sponsor and IRBwithin 5 working days.
* Unanticipated adverse device effects have a 10-day reporting window.
References:21 CFR 812.150(a)(4).

NEW QUESTION # 66
In accordance with the ICH E2A Guideline, the sponsor must report an adverse event that is life-threatening, unexpected, and associated with the investigational drug to the regulatory authority as soon as possible but no later than how many calendar days after first knowledge of the event?

A. 1 day
B. 7 days
C. 15 days
D. 10 days

Answer: B

Explanation:
Serious adverse events are subject to expedited reporting requirements.
* ICH E2A 3.2.2:"Fatal or life-threatening unexpected ADRs should be reported as soon as possible but no later than7 calendar daysafter first knowledge."
* ICH E2A 3.2.3:Other serious unexpected events must be reported within 15 days.
Thus, the 7-day rule applies tolife-threatening and unexpected events(as in this case).
Correct answer:B (7 days).
References:
ICH E2A, §3.2.2.

NEW QUESTION # 67
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

Answer: D

Explanation:
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).

NEW QUESTION # 68
A pharmaceutical company is developing a biologic study. In accordance with ICH, which of the following items should be included in an investigator's brochure (IB)?

A. Results of recent nude mouse study
B. Lab draw requirements
C. Dispensing instructions
D. Schedule of events

Answer: A

Explanation:
TheInvestigator's Brochure (IB)compilesclinical and nonclinical dataon an investigational product relevant to human study.
* ICH E6(R2) 7.2.3:The IB should summarizenonclinical pharmacology, toxicology, pharmacokinetics, and efficacy data, including results of animal studies.
* ICH E6(R2) 7.2.4:It should also includeavailable clinical trial dataand safety experience.
The "results of recent nude mouse study" (B) are nonclinical data, which appropriately belong in the IB. Lab draw requirements (A), dispensing instructions (C), and schedules of events (D) are operational/procedural and are found in theprotocol, not the IB.
Thus, the correct answer isB (Results of recent nude mouse study).
References:
ICH E6(R2), §7.2.3-7.2.4 (Contents of Investigator's Brochure).

NEW QUESTION # 69
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