Detailed SOCRA CCRP Study Plan | CCRP Exam Dumps Free

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q123-Q128):

NEW QUESTION # 123
After the sponsor's auditor completes the final audit report for a Phase II trial with an investigational new drug, which of the following is responsible for providing the audit certificate to the clinical site?

Answer: C

Explanation:
Audits are part of sponsor quality assurance to ensure trial compliance.
* ICH E6(R2) 5.19.3:"The sponsor's auditing procedures should include the provision of anaudit certificatewhere required."
* ICH E6(R2) 8.2.20:Audit certificates are essential documents generated and retained by the sponsor.
IRBs (A), regulators (B), and DSMBs (C) are not responsible for audit documentation. Therefore, only the sponsorissues and maintains audit certificates, providing them to sites when appropriate.
Correct answer:D.
References:
ICH E6(R2), §5.19.3.
ICH E6(R2), §8.2.20.


NEW QUESTION # 124
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?

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 # 125
Which of the following should a clinical investigator include in a submission to an IRB/IEC for a Phase IV drug study?

Answer: D

Explanation:
For IRB/IEC submissions, investigators must disclose subject-related information that may impact voluntariness or fairness of participation.
* 21 CFR 56.111(a)(3):The IRB must ensure that subject selection is equitable.
* 21 CFR 50.25(a)(3):Requires disclosure of "any compensation and/or medical treatments available if injury occurs."
* ICH E6(R2) 4.8.10(n):Informed consent should describe "any compensation and/or reimbursement to subjects." Thus,compensation amountsmust be reviewed by IRB/IEC to ensure they are not coercive or excessive.
Budgets (A), marketing plans (C), and contracts (D) are administrative and not part of IRB submission requirements.
Correct answer:B (The amount of payments and compensation to subjects).
References:
21 CFR 50.25(a)(3).
ICH E6(R2), §4.8.10(n).


NEW QUESTION # 126
According to the ICH/GCP Guideline, which of the following should a sponsor provide to the clinical investigator before entering into a clinical trial agreement?

Answer: D

Explanation:
Before an investigator can commit to conducting a trial, they must review thestudy protocol.
* ICH E6(R2) 4.5.1:The investigator should conduct the trial in compliance with theprotocol approved by the IRB/IEC and sponsor.
* ICH E6(R2) 4.2.3:The investigator should be thoroughly familiar with the appropriate use of the investigational product as described in the investigator's brochure and the current approved protocol.
Although resources, training, and equipment are important, the fundamental step is provision of theprotocol, which forms the legal and ethical framework for study conduct. No trial agreement can be finalized until both parties agree on theprotocol details.
References:ICH E6(R2), §§4.2.3, 4.5.1.


NEW QUESTION # 127
A sponsor is permitted to charge for an investigational drug but must provide what documentation?

Answer: B

Explanation:
* 21 CFR 312.8(b):Sponsors may charge for investigational drugs only if they demonstrate that the drug providespotential clinical benefitand asignificant advantageover existing therapy.
* FDA must approve charging requests.
References:21 CFR 312.8(b).


NEW QUESTION # 128
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