Get SOCRA CCRP Exam Practice Questions - Real and Updated

Answer : A

The investigator holds ultimate responsibility for all data reported.

ICH E6(R2) 4.9.1: ''The investigator is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor on the CRFs and all required reports.''

Monitors (D) verify data accuracy but are not responsible for data quality. Quality specialists (B) and IRB staff (C) have no role in data entry.

Correct answer: A (The clinical investigator).

ICH E6(R2), 4.9.1.

Answer : B

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 amounts must 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).

21 CFR 50.25(a)(3).

ICH E6(R2), 4.8.10(n).

Answer : D

The Investigator's Brochure (IB) is updated by the sponsor to reflect new scientific or clinical information.

ICH E6(R2) 7.3: ''The sponsor should revise the IB as soon as new, significant information becomes available.''

ICH E6(R2) 4.1.5: Requires the investigator to ensure staff are informed, but there is no requirement to notify IRB/IEC unless subject safety, rights, or risk profile is affected.

Since this update contained no changes related to subject safety, the investigator is not obligated to notify IRB/IEC, DSMB, or regulators. The updated IB must simply be filed in the regulatory binder and implemented at the site.

Thus, the correct answer is D (No notification is required).

ICH E6(R2), 7.3 (Updating the Investigator's Brochure).

ICH E6(R2), 4.1.5 (Investigator responsibilities for informing staff).

Answer : B

The FDA has full regulatory authority to inspect IRB/IEC records.

21 CFR 56.115(b): ''The IRB shall permit representatives of the Food and Drug Administration to inspect and copy all records maintained... at reasonable times and in a reasonable manner.''

Thus, FDA may inspect and copy IRB/IEC records without requiring an affidavit or invitation. This ensures regulatory oversight and human subject protection.

Incorrect options:

(A) limits authority incorrectly.

(C) is false --- FDA explicitly regulates IRBs.

(D) is false --- FDA does not need IRB invitation.

Correct answer: B.

21 CFR 56.115(b).

Answer : D

In device trials, unanticipated adverse device effects (UADEs) must be promptly reported.

21 CFR 812.150(a)(1): ''An investigator shall submit to the sponsor and the reviewing IRB a report of any unanticipated adverse device effect as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect.''

In this case, severe burns with blistering go beyond the anticipated effect of mild burns listed in the investigational plan. Therefore, it qualifies as a UADE and triggers expedited reporting. Options A, B, and C are too short; the regulation specifically mandates a 10 working day maximum timeframe.

Thus, the correct answer is D (10 working days).

21 CFR 812.150(a)(1) (Reporting requirements for investigators).