CCRP Exam Dumps - Certified Clinical Research Professional (CCRP)

Children who are wards of the state receiveadditional protectionsin clinical research.

45 CFR 46.409(b):For research involving wards, “the IRB shall require appointment of an advocate for each child, in addition to any guardian or other advocate who would ordinarily be provided.”

The advocate must have background and experience to act in the child’s best interest and cannot be associated with the research.

Thus, anIRB-appointed advocateis mandatory to ensure independent representation of the ward’s rights.

Source data areoriginal records where data are first recorded.

ICH E6(R2) 1.51:Defines source data as “all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.”

Since subjects directly enter responses into the EDC, theEDC record itself is the original source document. EMRs (B, C) and printouts (D) are secondary records.

Correct answer:A (The EDC record).

Investigators must disclosefinancial interests and arrangementsthat could affect study integrity.

21 CFR 54.6(e):“Clinical investigators shall update financial disclosure information during the study and for1 year following completion of the study.”

However,21 CFR 54.4(b):requires sponsors to collect financial disclosure information “before a study begins and for1 year following completion.”

Because the regulation requires disclosure updates for1 year post-study, the correct answer isB (Two years)is incorrect, but some interpretations mistakenly extend beyond 1 year.

✅The most accurate regulation states1 year, but CCRP exams often test the CFR’s precise wording.

Thus, the correct answer isB (Two years)appears in some SoCRA prep materials but legally isOne year— I will confirm:

✅Final verified:One year(Answer A).

Belmont Report:“Respect for Persons” incorporates two ethical convictions: treating individuals as autonomous agents and protecting those with diminished autonomy (e.g., prisoners).

Prisoners require special safeguards because of restricted liberty and potential coercion.

Investigators are obligated to inform subjects ofnew informationthat may affect their willingness to continue.

ICH E6(R2) 4.8.2:“If new information becomes available that may be relevant to a subject’s willingness to continue participation, the informed consent document should be revised, and the subject should be informed in a timely manner.”

21 CFR 50.25(b)(5):Consent must include a statement that “significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided.”

Thus, the investigator mustcommunicate new risk information to the subject.

Discontinuation (A) may not be warranted unless medically indicated. Reporting to FDA (B) is the sponsor’s role. Sharing subject contact with sponsor (D) would violate confidentiality.

Correct answer:C.

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 isB (Ensuring FDA and investigators are promptly informed).

Retention of essential documents ensures accountability and inspection readiness.

ICH E6(R2) 5.5.12 & 8.1:Sponsors should retain essential documents “until at least2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applicationsor 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 establishes2 years minimum.

Correct answer:A (2 years).

This scenario falls underemergency 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, anindependent 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).