CCRP Certified Clinical Research Professional (CCRP) Questions and Answers

The informed consent document (ICD) is a cornerstone of ethical clinical research, ensuring voluntary participation and protection of subject rights.

21 CFR 50.25(a):Requires the consent form to containall basic elements, including study purpose, risks, benefits, alternatives, confidentiality, compensation, and voluntariness.

ICH E6(R2) 4.8.10:Expands on these requirements, ensuring the ICD contains every mandated element without omission.

Thus, the correct statement is that the ICDmust include all applicable mandated basic elements(D). Options A and B confuse who signs—subjects or legally authorized representatives sign when applicable, not the IRB chair. Option C is incorrect because leaving out elements would violate compliance.

Correct answer:D.

21 CFR 56.109(a):IRB must review and approve any protocol amendments before implementation.

ICH E6(R2) 4.5.2:Changes affecting subjects (e.g., genomic testing) require IRB/IEC approval and updated consent.

Thus, site must first obtainIRB approval for revised protocol and ICF.

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).

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).

Monitors verify compliance with protocol, sponsor SOPs, GCP, and regulations.

ICH E6(R2) 5.18.4:Outlines monitor responsibilities, including verifying informed consent, protocol compliance, investigational product accountability, and adherence to sponsor SOPs.

Monitors must also be familiar with subject-facing documents (A) and storage requirements for investigational product (B).

However,IRB/IEC requirements for reporting to regulatory authoritiesare outside a monitor’s scope. That responsibility lies with investigators and IRBs under21 CFR 56.108(b).

Thus, the correct answer isD.

The FDA has full regulatory authority to inspect IRB/IEC records.

21 CFR 56.115(b):“The IRB shall permit representatives of the Food and Drug Administration to inspect and copy all records maintained… at reasonable times and in a reasonable manner.”

Thus, FDA mayinspect and copyIRB/IEC records without requiring an affidavit or invitation. This ensures regulatory oversight and human subject protection.

Incorrect options:

(A) limits authority incorrectly.

(C) is false — FDA explicitly regulates IRBs.

(D) is false — FDA does not need IRB invitation.

Correct answer:B.

Children are a vulnerable population. U.S. regulations require IRB/IEC judgment about when and howassentis obtained, in addition to parental permission. Exact extracts:

45 CFR 46.408(a): “The IRB shall determine…whether and to what extent children are capable of providing assent.”

ICH E6(R2) 4.8.12: “Where a subject is unable to give consent personally,assent should be obtained when appropriate, in accordance with applicable regulatory requirement(s).”Thus, the additional protection is IRB-determined, age-appropriate assent (B). Options A, C, and D are not universal requirements for all pediatric research.

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 isA (At any time, at the discretion of the IRB/IEC).

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).

When a physician investigates amedical device for a new use (off-label indication), FDA regulations classify this as aSignificant Risk Device Study, requiring anInvestigational Device Exemption (IDE)in addition to IRB approval.

21 CFR 812.20(a):“A sponsor shall submit an application to FDA for aninvestigational device exemption (IDE)if the device is to be used in a clinical investigation to determine safety and effectiveness.”

21 CFR 812.2(b):Significant Risk device studies requireboth FDA and IRB approvalbefore initiation.

An IND (B) applies to drugs and biologics, not devices. Manufacturer permission (A, D) is not a regulatory requirement, although collaboration may be necessary. OHRP approval is not applicable.

Thus, the correct answer isC (IRB/IEC approval and an FDA IDE).

ICH requiresimmediatereporting of all SAEs to the sponsor (except those protocol-identified as not requiring immediate reporting). Exact extract:

ICH E6(R2) 4.11.1: “The investigatorshould report all serious adverse events immediately to the sponsorexcept for those SAEs that the protocol… identifies as not needing immediate reporting.”Therefore, “Immediately” (A) is correct. The other timeframes are not aligned with ICH GCP for initial SAE notification from investigator to sponsor.

When reviewing protocols, IRBs/IECs are primarily responsible forsafeguarding human subjectsby 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 afeasibility issue, addressed by investigators and sponsors, not IRBs.

Education of the study team (C) is confirmed by thesponsor 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 onjustice and fairness in subject selectionas part of the Belmont Report principles.

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

ICH E6(R2) 4.5.1:“The investigator should conduct the trial in compliance with the protocol approved by IRB/IEC.”

Deviations must not occur unless to eliminate hazard. Eligibility criteria cannot be overridden by investigator opinion.

Thus, enrollment requires protocol amendment and IRB approval.

TheInvestigator’s Brochure (IB)is a critical regulatory document designed to provide investigators with comprehensive knowledge about an investigational product.

ICH E6(R2) 7.1:Defines the IB as “a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects.”

ICH E6(R2) 7.2.2:Specifies the IB should contain asummary of pharmacological, toxicological, pharmacokinetic, and metabolic studies in animals, as well as results from previous human experience.

The purpose is to allow investigators to makerisk-benefit assessments, support protocol design, and ensure subject safety.

Incorrect options:

A (instructions to conduct study) describes theprotocol, not the IB.

C (financial disclosures) are required under21 CFR 54, not part of the IB.

D refers totrial master file/essential documents, not the IB.

Therefore, the IB’s defining function is to provide ascientific summary of preclinical and clinical datasupporting safe human use.

21 CFR 54.4(b):Requires disclosureduring the study and for 1 year after completion.

After three years, no disclosure is required.

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.

Form FDA 1572 is the “Statement of Investigator” for IND studies.

21 CFR 312.53(c)(1)(vi)(b):Requires investigators to “read and understand the Investigator’s Brochure.”

By signing, the investigator also agrees to comply with regulations, maintain records, and supervise study conduct.

Other options (B–D) are not part of 1572 requirements.

Correct answer:A.

ICH E6(R2) 1.11:CRFs are documents used to record protocol-required data reported to sponsor.

Sites keep originals; sponsor retains copies.Consent forms and medical records stay at site only.

Informed consent is a fundamental ethical requirement. If it is violated in a device trial, the FDA requires rapid reporting.

21 CFR 812.150(b)(5):States that a sponsor shall submit to FDA “any report of use of a device without obtaining informed consent, within5 working daysafter the sponsor first receives notice of such use.”

This expedited reporting ensures FDA oversight of serious violations and protection of human subjects.

Incorrect options:

A (1 day) is overly strict and not codified.

C (10 days) and D (30 days) are too delayed to meet regulatory intent of immediate oversight.

Thus, the correct timeline iswithin 5 working days.

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.

Sponsors must reportserious, 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 bothserious and unexpectedshall be reported…as soon as possible but no later than 7 calendar daysafter the sponsor’s initial receipt of the information, if it is fatal or life-threatening.”

ICH E2A 4.2:Requires expedited reporting oflife-threatening or fatal SUSARswithin 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 requiring7-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 isC.

Monitoring reports are sponsor-controlled documents.

ICH E6(R2) 5.18.6:“The monitor should submit a written report to the sponsor after each trial-site visit… The sponsor should review and follow up on the monitoring report.”

ICH E6(R2) 8.1 & 8.2.22:Monitoring visit reports are essential documents maintained by the sponsor.

Investigators are not required to retain monitoring reports; they maintain site regulatory binders and subject records. The study coordinator assists investigators, but does not hold sponsor-owned reports. IRBs also do not receive sponsor monitoring reports.

Thus, the correct answer isB (The sponsor).

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

May delegate to pharmacist or coordinator, butultimate responsibilitylies with investigator.

Monitoring ensures trial integrity and subject safety.

ICH E6(R2) 5.18.3:“The sponsor should ensure that the trials are adequately monitored. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial.”

Monitoring must occurbefore (initiation visit), during (periodic), and after (closeout).

It is not limited to fixed weekly or monthly intervals (A, B) and not as infrequent as yearly (D). Instead, it isrisk-adapted and flexible, but must cover all phases of the study.

Correct answer:C (Timely manner before, during, and after).

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).

Recruitment materials must be reviewed to protect subjects from misleading or coercive messaging.

21 CFR 56.111(a)(3):IRBs must ensure equitable subject selection.

ICH E6(R2) 3.1.2:IRBs safeguard rights, safety, and well-being, including review of recruitment strategies.

FDA and OHRP do not approve recruitment materials; responsibility lies withIRB/IEC.

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.

ICH E6(R2) 4.2.4:“The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, investigational product, and trial-related duties.”This responsibility cannot be delegated to sponsor or IRB.

Therisk-benefit ratiois 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.

370 × 1.20 =444 mg/m².

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

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… andat 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 leastone unaffiliated member (D)to ensure independence.

Thus, the correct answer isD (At least one unaffiliated individual).

The U.S. Code of Federal Regulations (CFR) specifies when sponsors must notify FDA of changes to investigational drug studies under 21 CFR 312.30. A protocol amendment is required if there is:

A change to the protocol (e.g., objectives, design, subject population, dosing, or procedures).

The addition of a new investigator.

A change in the chemistry, manufacturing, or controls (CMC) that could significantly affect product quality or safety.

Among the listed options, a change in the manufacturing site (D) directly falls under significant manufacturing changes, requiring FDA submission. Changes in investigator financial interests (B) are covered under 21 CFR 54 and reported separately, not as protocol amendments. Addition of a sub-investigator (C) does not require a formal amendment, only site-level documentation and delegation log update. Addition of a monitoring test (A) may affect the protocol, but not necessarily mandate an amendment unless it changes objectives or subject safety endpoints.

Therefore, the correct answer is D. This ensures FDA oversight of product safety, efficacy, and compliance with CMC standards before investigational use.

Unblinding procedures are aprotocol-level responsibilitybecause 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, andprocedures 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 isC (The study protocol), as it outlines unblinding steps and documentation requirements.

The regulatory binder (investigator site file) must contain documents verifying qualifications of all personnel. These include curricula vitae (CVs), professional licenses, and training certificates.

ICH E6(R2) 4.1.5: “The investigator should ensure that all persons assisting with the trial are qualified by education, training, and experience… Current curriculum vitae and/or other relevant documents evidencing qualifications should be maintained.”

21 CFR 312.53(c)(1): Sponsors must select investigators qualified “by training and experience,” and investigators must provide sufficient documentation, typically updated CVs.

Letters of promotion (A), training brochures (B), or performance reviews (C) may remain in personnel files but are not required regulatory documents. The only acceptable regulatory proof is an updated CV (D), which reflects the individual’s training and qualifications for their new role.

Therefore, the correct answer is D (Updated CV). This ensures compliance with ICH and FDA requirements for staff qualification documentation in clinical research.

Drug storage conditions are essential to maintaining investigational product (IP) integrity. According to ICH:

ICH E6(R2) 5.13.3:“The sponsor should ensure that investigational products are stored… under appropriate conditions as specified by the sponsor and in accordance with applicable regulatory requirement(s).”

ICH E6(R2) 4.6.4:“The investigator/institution should store the investigational product(s) as specified by the sponsor (and in accordance with applicable regulatory requirement(s)), and ensure that product(s) are used only in accordance with the approved protocol.”

During site qualification/selection, the monitor evaluates storage conditions — particularlytemperature ranges— to ensure the site can meet the stability requirements for the IP. Factors like staff numbers, space, and cost are operational considerations but not regulatory determinants of site qualification.

Thus, the correct answer isC (Storage facility temperature range). This ensures compliance with sponsor specifications, product stability, and ultimately subject safety.