SOCRA CCRP Exam Practice Test Instant Access

Question 1

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?

C31

D35

Answer : B

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).

Question 2

A study coordinator is preparing an IRB submission for a Phase II oncology study. Which document must be included?

ACase report forms

BRecruitment materials

CRecord storage plan

DList of potential subjects

Answer : B

ICH E6(R2) 3.1.2 & FDA Recruitment Guidance (1998): Recruitment materials must be reviewed by IRB to ensure no coercion or misleading claims.

CRFs and storage plans are sponsor/site tools, not IRB-reviewed documents.

Question 3

In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?

AOverseeing the administration of the investigational drug to the subjects

BEnsuring that the FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug

CMaintaining case histories that record all observations and other data pertinent to the investigation

DSubmitting progress reports to the reviewing IRB/IEC

Answer : B

Sponsors are responsible for distributing safety updates across all investigators and the FDA.

21 CFR 312.55(b): ''The sponsor shall promptly notify all participating investigators, and the FDA, of new significant adverse effects or risks with respect to the drug.''

Other responsibilities fall elsewhere:

Case histories (C) are maintained by investigators (21 CFR 312.62(b)).

Progress reports to IRBs (D) are the investigator's duty (21 CFR 312.66).

Administration of investigational drug (A) is managed by the investigator at site level.

Thus, the correct answer is B (Ensuring FDA and investigators are promptly informed).

21 CFR 312.55(b) (Sponsor notification requirements).

Question 4

An unconscious patient experiencing life-threatening cardiac arrhythmias has been admitted to an emergency room. No FDA-approved treatment is available, and no legal representative is present. The clinical investigator determined that the use of an investigational antiarrhythmic drug is required. In accordance with the CFR, who must certify the investigator's determination?

AA sub-investigator

BAn independent physician

CThe sponsor's study monitor

DThe sponsor's medical monitor

Answer : B

This scenario falls under emergency use of investigational drugs without informed consent.

21 CFR 50.23(a): Allows waiver of informed consent if subject faces a life-threatening condition, available treatments are unproven, and immediate use is required.

21 CFR 50.23(a)(3): Requires that ''the determination... be reviewed and concurred with by a physician who is not otherwise participating in the clinical investigation.''

Thus, an independent physician (not part of the trial team) must certify the necessity of emergency investigational use.

Sponsors and monitors (C, D) are not authorized by regulation to make such determinations. Sub-investigators (A) lack independence and would be conflicted.

Correct answer: B (Independent physician).

21 CFR 50.23(a)(3).

Question 5

An investigator is working with a new sponsor to submit a cardiovascular trial to the IRB/IEC. In accordance with the ICH GCP Guidelines, which parties should sign the protocol to confirm agreement that the trial will be conducted as agreed?

AThe investigator/institution and the sponsor

BThe investigator/institution and the delegated site staff

CThe sponsor and the IRB/IEC

DThe sponsor and the FDA

Answer : A

The protocol signature page documents agreement between the sponsor and the investigator/institution to conduct the trial in compliance with ICH GCP, the protocol, and regulatory standards.

ICH E6(R2) 8.2.2 (Signed protocol and amendments): Requires ''the sponsor and investigator/institution to sign the protocol and amendments, confirming agreement.''

ICH E6(R2) 4.5.1: ''The investigator should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, approved by the regulatory authority(ies) and by the IRB/IEC.''

The sponsor--investigator signatures ensure shared accountability for subject protection, data integrity, and adherence to trial methodology. Neither delegated staff (B) nor IRB/IEC (C) nor FDA (D) sign protocols. These bodies approve or oversee, but do not formally enter into execution of the protocol.

Thus, the correct answer is A (The investigator/institution and the sponsor).

ICH E6(R2), 8.2.2 (Signed protocol and amendments).

ICH E6(R2), 4.5.1 (Investigator compliance with protocol).

Question 6

The study coordinator for a new Phase III vaccine study is preparing documents for IRB/IEC submission. According to the ICH GCP Guidelines, which of the following documents should be included in the submission?

ALocal lab normal ranges

BCase report forms

CRecruitment materials

DThe investigators' CVs

Answer : C

IRBs/IECs are responsible for ensuring that subject recruitment is ethical and not coercive.

ICH E6(R2) 3.1.2: The IRB/IEC safeguards subjects by reviewing recruitment procedures and materials.

21 CFR 56.111(a)(3): Requires equitable subject selection, which extends to advertisements and recruitment.

FDA Guidance on Recruiting Study Subjects (1998): States that ''advertisements and recruitment materials must be reviewed and approved by the IRB prior to use.''

While CVs (D) and lab ranges (A) are essential documents for study feasibility and quality, they are not mandatory for IRB approval package. CRFs (B) are sponsor tools for data collection, not subject-facing, and thus not reviewed by IRBs.

Correct answer: C (Recruitment materials).

ICH E6(R2), 3.1.2.

FDA Recruitment Guidance, 1998.

Question 7

A subject on a multi-drug regimen could not tolerate a non-investigational drug. Can the investigational regimen continue?

AYes, per protocol

BOnly after sponsor and IRB approval

COnly after medical monitor approval

DOnly for a short time, then change to placebo

Answer : B

ICH E6(R2) 4.5.1: Investigators must follow the protocol approved by the IRB/IEC.

Any modification that is not pre-specified must be approved by sponsor and IRB before continuing.

Only deviations eliminating immediate hazard can be done without prior approval; in this case, continuation requires sponsor + IRB agreement.

SOCRA Certified Clinical Research Professional CCRP Exam Practice Test