Key details for this exam, checked against the published exam outline
Each question shows the correct answer and an explanation of why it is right
A study will enroll 420 subjects over 3.5 years. What is expected average monthly accrual?
420 subjects 42 months (3.5 years) = 10 subjects/month.
However, ''expected average'' often rounds up to next whole number, ensuring enrollment goals are met. Thus, 11/month is correct.
This calculation is important for feasibility assessments and protocol planning.
When can the IRB/IEC require that additional information be given to subjects as part of informed consent?
The IRB/IEC is empowered to protect subjects and ensure informed consent remains accurate, complete, and understandable.
ICH E6(R2) 3.1.2: ''The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid... when considering the adequacy and completeness of the written information to be provided to the subjects.''
21 CFR 56.109(b): ''The IRB shall require that information given to subjects as part of informed consent is in accordance with 50.25. The IRB may require that information, in addition to that specifically mentioned in 50.25, be given to the subjects when in its judgment the information would meaningfully add to the protection of the rights and welfare of subjects.''
This confirms that the IRB/IEC has unilateral authority to request additional information at any time, regardless of sponsor or investigator agreement.
Thus, the correct answer is A (At any time, at the discretion of the IRB/IEC).
ICH E6(R2), 3.1.2 (IRB responsibilities).
21 CFR 56.109(b) (IRB review of informed consent).
In accordance with 21 CFR Part 11, a closed electronic records system must do all EXCEPT:
21 CFR 11.10: Requires validation, audit trails, secure access, but does not mandate printing capability.
Thus, (D) is the exception.
Which of the following is one of the responsibilities of an investigator?
Investigators are required to maintain accurate subject records, often referred to as case histories.
21 CFR 312.62(b): ''An investigator shall prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation.''
ICH E6(R2) 4.9.0: Reinforces that investigators are responsible for recording, handling, and storing clinical trial data.
Incorrect options:
B: Investigators may present protocols but cannot vote on IRB approval.
C: Sponsor responsibility (ICH E6 5.18).
D: Sponsors are responsible for IB updates (ICH E6 7.3.1).
Correct answer: A.
21 CFR 312.62(b).
ICH E6(R2), 4.9.0.
An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety. Which of the following parties, if any, is the investigator required to notify?
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).
In accordance with the CFR, the IRB/IEC membership must have:
IRBs must be diverse and independent to protect human subjects.
21 CFR 56.107(d): ''Each IRB shall include at least one member whose primary concerns are in nonscientific areas... and at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person affiliated with the institution.''
There is no minimum requirement of seven members (A). Nonscientists must be represented but not a majority (B). Clergy are not mandated (C). The critical safeguard is inclusion of at least one unaffiliated member (D) to ensure independence.
Thus, the correct answer is D (At least one unaffiliated individual).
21 CFR 56.107(d) (IRB membership requirements).
A subject on a multi-drug regimen could not tolerate a non-investigational drug. Can the investigational regimen continue?
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.
Exam domains verified against: Official SOCRA CCRP exam guide, last checked October 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.
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.
Common questions about the exam itself
