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A subject was instructed to do a glucose check 4 times a day for 10 days using an investigational glucose meter. The meter requires one new glucose test strip for each test. The subject received the meter along with 45 glucose test strips. How many unused test strips should the subject have after the 10 days?
This is a drug/device accountability calculation question, testing compliance with investigational product tracking.
The subject was instructed to perform 4 glucose checks per day.
Over 10 days, that equals 40 tests (4 10 = 40).
Each test requires 1 strip, so 40 strips used.
Subject was given 45 strips, leaving 5 unused after 10 days.
Investigators are responsible for maintaining accurate device/product accountability.
ICH E6(R2) 4.6.3: ''The investigator/institution should maintain records of the product's delivery to the trial site, the inventory, the use by each subject, and the return to the sponsor or alternative disposition.''
This ensures monitoring can confirm that product/device use aligns with the protocol and subject adherence.
Thus, the correct answer is B (5 unused test strips).
ICH E6(R2), 4.6.3 (Investigational product accountability).
After completion of a Phase III trial, which document should IRB/IEC retain?
21 CFR 56.115(a)(5): IRBs must retain records of IRB membership (names, qualifications, affiliations, occupations).
Other documents (contracts, enrollment logs, product labels) are site or sponsor responsibilities, not IRB's.
The sponsor discontinued the clinical development of an investigational product. In accordance with the ICH GCP Guidance, at least how long should the sponsor maintain all sponsor-specific essential documents?
Retention of essential documents ensures accountability and inspection readiness.
ICH E6(R2) 5.5.12 & 8.1: Sponsors should retain essential documents ''until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications or at least 2 years after formal discontinuation of clinical development of the investigational product.''
This standard balances subject protection with practical recordkeeping. Longer durations (B--D) may apply under institutional or national rules, but ICH establishes 2 years minimum.
Correct answer: A (2 years).
ICH E6(R2), 5.5.12, 8.1.
A study subject in a double-blinded, placebo-controlled Phase III study experienced a serious adverse event that could be related to the study drug. The clinical investigator is out of town, and the sub-investigator needs to break the blind. Where can the sub-investigator find a description of the unblinding procedure?
Unblinding procedures are a protocol-level responsibility because they involve trial design, safety management, and subject protection.
ICH E6(R2) 6.0 (Protocol and amendments): Requires the protocol to specify ''the treatment(s) and treatment periods, procedures for randomization and blinding, and procedures for breaking codes.''
ICH E6(R2) 4.7: ''The investigator should follow the trial's randomization procedure, if any, and should ensure that the code is broken only in accordance with the protocol.''
The informed consent (A) explains risks and rights but does not include operational unblinding procedures. The Investigator's Brochure (B) summarizes preclinical/clinical data but does not dictate site-specific trial management. The CRF (D) is for data capture and has no procedural detail.
Therefore, the correct answer is C (The study protocol), as it outlines unblinding steps and documentation requirements.
ICH E6(R2), 6.0 (Protocol content).
ICH E6(R2), 4.7 (Randomization and unblinding).
Protocol increases drug dose by 20%. Baseline: 370 mg/m. New dose = ?
370 1.20 = 444 mg/m.
Accurate dosing calculations are critical for protocol adherence and patient safety.
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Exam domains verified against: Official SOCRA CCRP exam guide, last checked September 2026.
Coordinate protocol development and initial study setup including document creation, stakeholder approvals, site selection, staff training, and compliance evaluation. This domain covers the foundational tasks before a clinical trial begins, from drafting study protocols to preparing informed consent forms and ensuring IRB review.
Execute study protocols, manage investigational products, identify and report safety issues, recruit and monitor subjects, maintain essential records, communicate with stakeholders, and conduct audits. This domain focuses on the active conduct of the clinical trial and the day-to-day operational responsibilities throughout the study lifecycle.
Sample question from this domain above: Q5
Perform closeout visit activities and develop final reports to IRB, sponsor, regulatory authorities, and clinical trials registry. This domain covers the wrap-up phase of a clinical trial including verification of documentation and accountability of investigational products.
Sample question from this domain above: Q3
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