CCRP Certified Clinical Research Professional (CCRP) Questions and Answers

Theshort form consent processis permitted when the subject is presented with a brief written statement that they were informed of the study, supplemented by an oral presentation.

21 CFR 50.27(b)(2):Requires the short form to be signed by the subject (or legally authorized representative)and a witness.

The witness ensures that oral consent was properly conveyed and understood.

The person obtaining consent must sign aseparate written summary, but not the short form itself.

Thus, the accurate answer isA: subject (or LAR) + witness.

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 anFDA violation.

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).

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.

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).

Record retention requirements ensure regulatory access to data even after development is discontinued.

21 CFR 312.62(c):“An investigator shall retain records… for2 years after the date a marketing application is withdrawn or discontinuedand FDA is notified.”

In this case, development was terminated15 May 2019. Therefore, the 2-year clock starts at discontinuation. Two years later is15 May 2021, but FDA requires records to be maintaineduntil afterthe 2-year period ends. Theearliest permissible destruction date is 16 May 2022 (C).

Options A and B are premature; D (2034) is far beyond requirements.

Thus, the correct answer isC (16 May 2022).

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).

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.

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).

Investigators must formally close out a trial with the IRB/IEC.

ICH E6(R2) 4.13.2:“Upon completion of the trial, the investigator/institution should provide the IRB/IEC with a summary of the trial’s outcome.”

21 CFR 312.66:Reinforces investigator’s duty to keep IRB informed throughout study lifecycle.

This applies regardless of whether outcomes were positive, negative, or inconclusive. IRBs are not concerned with sponsor payments (B) or publications (D).

Thus, the correct answer isA (Provide final report to IRB/IEC).

Investigators must provideevidence of qualificationsto conduct the study.

ICH E6(R2) 4.1.1:“The investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial.”

ICH E6(R2) 8.2.10:Essential documents include thecurriculum vitae (CV)or other documents evidencing investigator qualifications, submitted to both sponsor and IRB/IEC.

Proof of citizenship (A) and letters of recommendation (B) are irrelevant. A copy of a medical license (D) may be provided but isnot specifically requiredby ICH. The CV is the universally required document.

Thus, the correct answer isC (Curriculum vitae).

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.

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.

370 × 1.20 =444 mg/m².

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

The investigator/institution bears responsibility for site conduct, oversight of delegated tasks, and ensuring qualified, trained staff—regardless of employment source. Exact extracts:

ICH E6(R2) 4.1.1: “The investigator should bequalified… and haveadequate resourcesto properly conduct the trial.”

ICH E6(R2) 4.1.5: “The investigatorshould ensure that all persons assistingwith the trial areadequately informedabout the protocol, the investigational product(s), and their trial-related duties and functions.”

ICH E6(R2) 4.2.5: “The investigatormay delegate… butretains responsibilityfor the conduct of the trial at the site.”Therefore, the investigator/institution (B) must implement procedures and oversight to maintain integrity of trial duties.

Providing acopy of the signed consent formto 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 adirect 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.

IRBs must review protocols at least annually to ensure ongoing subject protection.

21 CFR 56.109(f):“An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year.”

ICH E6(R2) 3.1.4:“The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk, but at least once per year.”

This establishes12 monthsas the minimum required interval. More frequent reviews (e.g., 6 months) may occur for higher-risk studies, but longer intervals (24–36 months) are not permitted.

Correct answer:B (12 months).

21 CFR 312.23(a):Requires cover sheet, CMC information, and IB.

Financial disclosureis required separately under21 CFR 54, not part of IND content.

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.

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.

Source documentsare the original records where trial data are first recorded, from which Case Report Form (CRF) entries are verified.

ICH E6(R2) 1.52:Defines source documents as “original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, pharmacy dispensing records, recorded data from automated instruments, etc.).”

ICH E6(R2) 8.3.13:Requires maintenance of “source documents” to verify data integrity and allow monitoring/audits.

Pharmacy dispensing records (D) fit this definition, as they show initial data on investigational product dispensing and accountability. In contrast, subject instruction sheets (A) are communication tools, SOPs (B) are procedural guides, and the protocol (C) is a governing document, none of which qualify as original data records.

Therefore, the correct answer isD (Pharmacy dispensing records).

21 CFR 312.8(b):Sponsors may charge for investigational drugs only if they demonstrate that the drug providespotential clinical benefitand asignificant advantageover existing therapy.

FDA must approve charging requests.

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.

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.

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 anaudit certificatewhere 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 thesponsorissues and maintains audit certificates, providing them to sites when appropriate.

Correct answer:D.

Sponsor audits ensure systems comply with GCP.

ICH E6(R2) 5.19.3:“The sponsor’s auditing procedures should include a review ofquality assurance audits and audit reports.”

Audit reports document findings from independent evaluations and are essential for ensuring compliance.

SOPs (A) are reviewed during audits but are not mandated as standalone “audit review documents.” Personnel files (B) and financial reports (C) are not required under GCP auditing provisions.

Correct answer:D (Audit reports).

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).

The sponsor holds ultimate responsibility for trial oversight and compliance.

ICH E6(R2) 5.20.1:If noncompliance is discovered, the sponsor must “take prompt action to secure compliance” and, if necessary, terminate participation of the investigator/institution.

21 CFR 312.56(b):Sponsors must ensure proper conduct and report investigators who fail to comply to the FDA and IRB.

While investigators commit to protocol adherence, once deviations are identified,the sponsor must actto safeguard subjects and trial validity.

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).

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.

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.

Record retention is critical for regulatory inspection and subject protection.

21 CFR 56.115(b):IRBs must retain records forat least 3 yearsafter completion of the research.

ICH E6(R2) 3.4.3:Similarly requires retention of records for a minimum of 3 years after completion.

This allows audits, sponsor inspections, or regulatory reviews long after the study closes. Institutions may require longer retention, but federal minimum is3 years.

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.

21 CFR 812.150(a)(4):Any deviation from investigational plan made to protect the life or physical well-being of a subject in an emergency must be reported to the sponsor and IRBwithin 5 working days.

Unanticipated adverse device effects have a 10-day reporting window.

Outsourcing does not shift ultimate responsibility away from the sponsor. Exact extract:

ICH E6(R2) 5.2.1: “A sponsor may transfer any or all of the sponsor’s trial-related duties… to a CRO,but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.”Hence, D is correct.