CCRP Certified Clinical Research Professional (CCRP) Questions and Answers

21 CFR 312.32(c)(1)(ii): Sponsors must notify all participating investigators of any serious and unexpected suspected adverse reactions.

Investigators then inform IRBs and subjects as appropriate.

Minimal risk studies may qualify for exemption or expedited review under 45 CFR 46.101(b) .

45 CFR 46.109(f): “Unless an IRB determines otherwise, continuing review of research is not required for research eligible for expedited review and determined to involve no more than minimal risk.”

ICH E6(R2) 3.1.4: Requires IRB review for clinical trials, but exemptions exist for minimal risk studies.

Therefore, once exempted, there is no requirement for continuing review , unless specifically required by the IRB. Submission at closure is optional depending on institutional policy but not a federal requirement.

Thus, the correct answer is D (No such requirement).

The Nuremberg Code (1947) established voluntary consent as essential following Nazi war crimes.

Helsinki (1964) built upon it; Belmont Report (1979) refined U.S. ethics.

Thus, the correct foundational WWII document is the Nuremberg Code .

When reviewing protocols, IRBs/IECs are primarily responsible for safeguarding human subjects by evaluating risks, benefits, and fairness in subject selection.

21 CFR 56.111(a)(3): “In making its determination the IRB shall determine that… selection of subjects is equitable.”

45 CFR 46.111(a)(3): Repeats this requirement, emphasizing fairness across gender, race, age, and socioeconomic status.

Other options:

Patient population availability (A) is a feasibility issue , addressed by investigators and sponsors, not IRBs.

Education of the study team (C) is confirmed by the sponsor and investigator , not IRB.

Funding sources (D) may raise conflict of interest concerns, but they are not IRB approval criteria per federal regulations.

Thus, IRBs focus on justice and fairness in subject selection as part of the Belmont Report principles.

21 CFR 11.100(a): Requires that electronic signatures be “unique to one individual and shall not be reused or reassigned to anyone else.”

This ensures accountability and audit trail integrity.

The FDA record retention requirement for investigational drug studies is clearly outlined in 21 CFR 312.57(c) and 21 CFR 312.62(c) .

21 CFR 312.57(c): “A sponsor shall retain the records and reports… for 2 years after a marketing application is approved for the drug; or, if an application is not approved, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.”

21 CFR 312.62(c): Investigators also must retain study-related records for 2 years following the date a marketing application is approved or 2 years after the investigation is discontinued.

This requirement ensures FDA can audit investigational product data even after approval to confirm compliance and verify trial results. Longer retention (e.g., 15 years) may be institutional or sponsor policy but is not mandated by federal law.

Thus, the correct answer is A (2 years) .

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.

The protocol must provide scientific rationale, including prior nonclinical findings that justify human research.

ICH E6(R2) 6.2.2: “The protocol should include… a summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial.”

Other listed options belong elsewhere:

IRB approvals (A) are separate administrative records.

SOPs for data collection (B) are sponsor-level procedural documents.

Investigator selection (C) is a sponsor’s responsibility, not protocol content.

Thus, the correct answer is D (Summary of nonclinical findings with clinical relevance).

Form FDA 1572 is the investigator’s signed agreement to follow regulations.

21 CFR 312.53(c)(1)(vi)(c): Requires investigators to sign Form 1572, committing to conduct trials in accordance with FDA regulations (21 CFR 50 & 56) .

The form includes commitments to personally supervise, obtain informed consent, maintain records, and permit FDA inspections.

It does not include financial disclosures (covered under 21 CFR 54 ) or preclinical data (in the IB ).

The Belmont Report (1979) established three 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 embodies Respect 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 is B (Respect for persons).

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.

The investigator is directly responsible for ensuring that the IRB/IEC reviews and approves the research both initially and on a continuing basis. This responsibility is not delegable to the sponsor or study staff.

ICH E6(R2) 4.4.1: “Before initiating a trial, the investigator/institution should have written and dated approval/favorable opinion from the IRB/IEC for the trial protocol, written informed consent form, consent form updates, and any other written information to be provided to subjects.”

21 CFR 312.66: “An investigator shall assure that an IRB that complies with the requirements… will be responsible for the initial and continuing review and approval of the proposed clinical study.”

This means that while the sponsor submits documents to the FDA and oversees general compliance, the investigator has the obligation to obtain and maintain IRB approval at their site. The monitor or study coordinator may assist in documentation, but legal responsibility rests with the investigator.

Thus, the correct answer is C (The investigator) .

21 CFR 56.110(b): IRBs may use expedited review for minor changes in previously approved research.

Expedited review cannot be used for initial reviews of high-risk protocols or major modifications.

Correct answer is D .

370 × 1.20 = 444 mg/m² .

Accurate dosing calculations are critical for protocol adherence and patient safety.

ICH E6(R2) 4.6.1: The investigator is responsible for investigational product accountability at the site.

21 CFR 312.61: Investigators must administer the investigational drug only to subjects under their supervision.

The IRB maintains meeting minutes (A), preclinical studies are sponsor tasks (B), and financial interest documentation (C) is covered under sponsor reporting. Thus, D is correct .

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.

When a trial ends at a site, the investigator has an obligation to submit a final report to the IRB/IEC. This is outlined in both ICH and CFR:

ICH E6(R2) 4.13: “Upon completion of the trial, the investigator should provide the IRB/IEC with a summary of the trial’s outcome.”

21 CFR 312.66: Requires investigators to “report to the IRB all changes in the research activity and all unanticipated problems involving risk, and to provide reports at the end of the study.”

The final report provides closure and documentation that the study was conducted ethically and in compliance with regulatory standards. Other documents listed in the options (monitoring reports, DSMB summaries, subject logs) may be retained by the sponsor or site, but they are not mandated for IRB submission.

Thus, the correct answer is A (Final Report). This ensures the IRB/IEC has an accurate record of study completion, outcome, and compliance with ethical oversight.

Sponsors must report serious, unexpected, and suspected adverse reactions (SUSARs) to the FDA.

21 CFR 312.32(c)(2): “Any adverse experience associated with the use of the drug that is both serious and unexpected shall be reported… as soon as possible but no later than 7 calendar days after the sponsor’s initial receipt of the information, if it is fatal or life-threatening.”

ICH E2A 4.2: Requires expedited reporting of life-threatening or fatal SUSARs within 7 days.

Among the options, only (C) — death from arrhythmias not previously identified in the Investigator’s Brochure and suspected to be drug-related — meets the definition of a SUSAR requiring 7-day expedited reporting . Events already listed in the IB (A, D) or unrelated to the drug (B) do not trigger expedited reporting.

Thus, the correct answer is C .

Handling of investigational product (IP), including returns, is governed by sponsor’s written procedures .

ICH E6(R2) 4.6.3: “The investigator/institution should maintain records of the product’s delivery, the inventory, the use by each subject, and the return to the sponsor or alternative disposition.”

ICH E6(R2) 5.13.3: “The sponsor should ensure that written procedures include instructions for… the return or alternative disposition of unused product(s).”

The IB (A) describes pharmacology and safety, not IP logistics. CRO agreements (C) cover contractual duties, not product return processes. Local pharmacy policies (D) may apply operationally but do not override sponsor-required procedures.

Thus, the correct answer is B (The sponsor’s written procedures).

Providing a copy of the signed consent form to subjects is a mandatory requirement.

21 CFR 50.27(a): “A copy shall be given to the person signing the form.”

ICH E6(R2) 4.8.11: Reinforces that “a copy of the signed and dated written informed consent form should be given to the subject.”

Failure to provide this copy constitutes a direct violation of informed consent regulations.

Other issues:

A & C concern proper short form process but do not invalidate informed consent if a copy was provided.

D concerns sponsor template, but the site’s responsibility is ensuring use of IRB-approved version.

Correct answer: B.

ICH E6(R2) 5.6.1: “The sponsor should ensure agreement from the investigator/institution on the financial aspects of the trial.” This ensures transparency in compensation, reimbursement, and budget.

21 CFR 812.7: Prohibits promotion of investigational devices or claiming safety/effectiveness until FDA approval is granted.

Investigational devices may only be used in clinical trials, not marketed.

Thus, promotion during an IDE study is an FDA violation .

Audits are part of sponsor quality assurance to ensure trial compliance.

ICH E6(R2) 5.19.3: “The sponsor’s auditing procedures should include the provision of an audit certificate where required.”

ICH E6(R2) 8.2.20: Audit certificates are essential documents generated and retained by the sponsor.

IRBs (A), regulators (B), and DSMBs (C) are not responsible for audit documentation. Therefore, only the sponsor issues and maintains audit certificates, providing them to sites when appropriate.

Correct answer: D.

The investigator holds ultimate responsibility for all data reported.

ICH E6(R2) 4.9.1: “The investigator is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor on the CRFs and all required reports.”

Monitors (D) verify data accuracy but are not responsible for data quality. Quality specialists (B) and IRB staff (C) have no role in data entry.

Correct answer: A (The clinical investigator).

For non–sponsor investigators, responsibilities are limited to site-level conduct and product accountability .

ICH E6(R2) 4.6.1: “Responsibility for investigational product(s) accountability at the trial site rests with the investigator/institution.”

21 CFR 312.61: Requires the investigator to administer investigational drugs only to subjects under their supervision and maintain control.

Other responsibilities listed belong to sponsors :

A: Reporting SAEs to FDA is a sponsor duty (investigators report to sponsor, not directly to FDA).

B: Monitoring at all sites is a sponsor responsibility.

C: Disseminating safety updates is a sponsor’s role.

Correct answer: D (Maintaining control of IP).

FDA regulations for investigational devices are found under 21 CFR 812. Risk classification determines whether a device is considered Significant Risk (SR) or Non-Significant Risk (NSR). The critical factor is how the device will be used in the specific study.

21 CFR 812.3(m): Defines a “significant risk device study” as one that “is intended as an implant, is purported or represented to be for a use in supporting or sustaining human life, or otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.”

Risk is judged within the context of the protocol — i.e., use of the device in that particular study (D).

Number of patients (A), device cost (B), or investigator experience (C) are irrelevant to FDA’s risk classification. For example, a stent used in an approved indication may be NSR, but if used in a new anatomical location, it may be SR.

Therefore, the correct answer is D. This ensures ethical review bodies and FDA assess safety in the intended clinical context rather than device attributes alone.

21 CFR 812.150(a)(1): Investigators must report unanticipated adverse device effects to the sponsor within 10 working days.

Sponsor is then responsible for notifying FDA and all investigators.

During study closeout, the monitor verifies subject protection, protocol compliance, and investigational product accountability.

ICH E6(R2) 8.1 & 8.4: Lists essential documents to be verified at closeout, including signed informed consent forms and investigational product accountability records.

21 CFR Part 11: Ensures electronic records are valid, so printed copies are not always necessary unless required for auditing.

Thus, the critical items for monitor review at closeout are informed consent forms (to confirm subject protection) and investigational product documentation (to confirm reconciliation and disposition).

Correct answer: D.

ICH E6(R2) 5.16: Sponsors must implement ongoing safety evaluation, including expedited and periodic reporting. FDA and IRB review but do not conduct active monitoring.

The risk-benefit ratio is a core responsibility of the IRB/IEC.

21 CFR 56.111(a)(2): “Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.”

ICH E6(R2) 3.1.2: IRB/IEC must safeguard rights, safety, and well-being of subjects, with special attention to risk-benefit evaluation.

Investigators (A) provide medical judgment but do not formally approve the risk-benefit balance. Sponsors (D) design studies but must submit to IRB for independent review. Legal counsel (C) is not part of the scientific/ethical evaluation.

Thus, IRB/IEC is directly responsible for approving the risk-benefit ratio.

Investigators must disclose financial interests and arrangements that could affect study integrity.

21 CFR 54.6(e): “Clinical investigators shall update financial disclosure information during the study and for 1 year following completion of the study .”

However, 21 CFR 54.4(b): requires sponsors to collect financial disclosure information “before a study begins and for 1 year following completion .”

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

✅ The most accurate regulation states 1 year , but CCRP exams often test the CFR’s precise wording.

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

✅ Final verified: One year (Answer A).

Phase IV studies (post-marketing) examine real-world safety and effectiveness.

ICH E8(R1): Describes Phase IV as “studies performed after drug approval to delineate additional information including the drug’s risks, benefits, and optimal use.”

They often test drugs in new or broader populations beyond original approval.

While dosing and schedules are Phase I–III, Phase IV focuses on new patient populations or long-term outcomes.

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) 5.2.1: “The sponsor is responsible for implementing and maintaining quality assurance and quality control systems… including allocation of trial-related duties.”

Although tasks may be delegated to CROs or site staff, accountability remains with the sponsor .

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.

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).