SOCRA Certified Clinical Research Professional (CCRP) CCRP Exam Dumps: Updated Questions & Answers (November 2025)

ICH E6(R2) 4.8.10(n):Consent must include explanation about confidentiality and possible publication.

If not included, specificsubject consentmust be obtained before publishing identifiable results.

Thus, subject’s explicit permission is required.

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).

TheBelmont Report (1979)establishedthree key ethical principles:

Respect for Persons:Requires informed consent, recognition of autonomy, and protection of vulnerable individuals.

Beneficence:Obligation to maximize benefits and minimize harm.

Justice:Ensuring fairness in subject selection and distribution of research burdens/benefits.

Voluntary informed consent embodiesRespect for Persons, as subjects are given adequate information and freedom of choice. “Do no harm” (A) is a Hippocratic principle but not Belmont terminology.

Thus, the correct answer isB (Respect for persons).

IRB/IEC review focuses onethical protection of human subjects. Equitable subject selection is a cornerstone principle.

45 CFR 46.111(a)(3):“In order to approve research… the IRB shall determine that:Selection of subjects is equitable.”

ICH E6(R2) 3.1.2:“The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects… with particular attention to trials that may include vulnerable subjects.”

Publication plans (A) are not required by IRBs. Access to patients (C) and sponsor qualifications (D) are evaluated by sponsors, not IRBs. The IRB’s role is ensuring fairness, minimizing coercion, and protecting vulnerable populations.

Thus, the correct answer isB (The selection of subjects is equitable).

ICH E6(R2) 1.52:Source documents are “original documents, data, and records… necessary for the reconstruction and evaluation of the trial.”

Their main role is to document treatment and verify CRFs.

This is adrug/device accountability calculation question, testing compliance with investigational product tracking.

The subject was instructed to perform4 glucose checks per day.

Over10 days, that equals40 tests (4 × 10 = 40).

Each test requires1 strip, so40 strips used.

Subject was given45 strips, leaving5 unusedafter 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 isB (5 unused test strips).

AnInvestigational New Drug (IND) applicationprovides FDA with data to justify human testing.

21 CFR 312.23(a)(3):The IND must contain “a description of the general investigational plan, including the rationale for the drug or the research study.”

The IND also includes preclinical safety data, manufacturing details, investigator qualifications, and study protocols.

Financial disclosures (D) are reported separately under21 CFR Part 54, not as part of the initial IND. Export applications (A) are covered under21 CFR 312 Subpart E. Profit sales (C) are not permitted under INDs.

Thus, the correct answer isB (Rationale and plan for human testing).

Theinformed consent processmust include all basic elements listed in federal regulations.

21 CFR 50.25(a)(4):Requires “a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.”

ICH E6(R2) 4.8.10(c):Mirrors this, requiring subjects to be informed of alternatives to participation, including available standard treatments.

This ensures the ethical principle ofRespect for Persons(Belmont Report), giving subjects the autonomy to choose among reasonable medical options.

Incorrect options:

A: Contact information must be provided, but it is for the investigator (or IRB), not sponsor.

B: Financial disclosures may be required for IRB review, not subject-facing.

C: Subjects do receive a copy, but it is not a required consentelementin regulations.

Correct answer:D.

The IB must be updatedas new significant safety information emerges.

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

ICH E2A:Requires sponsors to reportSuspected Unexpected Serious Adverse Reactions (SUSARs)in expedited reports and include them inIB updates or addenda.

A SUSAR report (B) represents new, unexpected, and serious safety information not previously documented, and therefore warrants inclusion as anIB addendumuntil the IB is formally updated.

Revised consent forms (A) are submitted to IRBs, not IBs. Site-specific SAE reports (C) remain at site/sponsor level, not in the IB. Product monograph updates (D) apply to approved products, not investigational ones.

Thus, the correct answer isB (SUSAR report).

21 CFR 11.10:Requires validation, audit trails, secure access, but does not mandate printing capability.Thus, (D) is the exception.