SOCRA CCRP Certified Clinical Research Professional (CCRP) Exam Practice Test

Upon study closure, investigators must maintain documentation that allows subject data to be linked back if necessary. TheSubject Identification Code Listis a key essential document for ensuring traceability while maintaining confidentiality.

ICH E6(R2) 8.3.21:“Subject Identification Code List — A list of all subjects randomized to trial numbers, allowing investigator to identify each subject in case follow-up is required. This list should be kept in a confidential manner and retained for the maximum retention period.”

ICH E6(R2) 8.4:Essential documents for investigators include items needed for subject identification, protocol compliance, and trial closure.

Other listed documents (randomization list, monitoring report, audit certificate) are maintained by the sponsor, not the investigator. Thesubject code listensures that in the event of a safety issue, regulatory authority queries, or subject withdrawal, the investigator can trace back records.

Thus, the correct answer isB (Completed Subject Identification Code List).

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).

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.”

Sponsors must confirm IRB approval before authorizing initiation.

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.

Theinvestigatorbears direct responsibility for ensuring IRB/IEC review and approval before initiating a study or implementing any amendments.

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, 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.”

While sponsors may provide protocol documents, the legal obligation to submit and maintain IRB/IEC approval rests with the investigator at each site. CROs act under sponsor delegation but cannot replace investigator accountability.

Thus, the correct answer isB (The investigator).

ICH directs investigators todocument and explainany deviation, with prompt reporting to IRB/IEC only when deviations are implemented to eliminate immediate hazards or as required. Exact extracts:

ICH E6(R2) 4.5.3: “The investigator should document and explain any deviationfrom the approved protocol.”

ICH E6(R2) 3.3.7 & 4.5.2 (paraphrased): deviations to eliminate immediate hazards must be reported as soon as possible.Here, absent immediate hazard, the required action is documentation and explanation (B).

TheBelmont Report (1979), issued by the U.S. National Commission, identifiesthree core ethical principlesguiding human subject research:

Respect for Persons(informed consent, autonomy, protection of vulnerable populations).

Beneficence(maximize benefits, minimize harms).

Justice(fairness in subject selection and treatment).

TheNuremberg Code (1947)was developed post-WWII to prevent unethical experiments.

TheDeclaration of Helsinki (1964, updated)is a World Medical Association document guiding international physician research ethics.

TheICH Guidelines (1996)outline harmonized regulatory requirements for good clinical practice.

Only the Belmont Report fits the description of a U.S.-based, principle-driven framework for human research ethics.

Thus, the correct answer isD (The Belmont Report).

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.

IRBs/IECs are responsible for ensuring that subject recruitment is ethical and not coercive.

ICH E6(R2) 3.1.2:The IRB/IEC safeguards subjects by reviewing recruitment procedures and materials.

21 CFR 56.111(a)(3):Requires equitable subject selection, which extends to advertisements and recruitment.

FDA Guidance on Recruiting Study Subjects (1998):States that “advertisements and recruitment materials must be reviewed and approved by the IRB prior to use.”

While CVs (D) and lab ranges (A) are essential documents for study feasibility and quality, they are not mandatory for IRB approval package. CRFs (B) are sponsor tools for data collection, not subject-facing, and thus not reviewed by IRBs.

Correct answer:C (Recruitment materials).

Minimal risk studiesmay qualify for exemption or expedited review under45 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 isno 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 isD (No such requirement).

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).

AnIndependent Data Monitoring Committee (IDMC or DSMB)is a group of independent experts established to review accumulating safety and efficacy data during a trial. Their main role is to ensure subject protection and trial integrity.

ICH E6(R2) 5.5.1:“The sponsor may consider establishing anindependent data-monitoring committee (IDMC)to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.”

Thus, DSMBs/IDMCsdo not perform trial approvals (A),do not design trials (C), anddo not select investigators (D). Their authority is strictly advisory, providing recommendations to sponsors about safety and whether continuation of the study is ethically justified. The sponsor makes the final decision, but DSMB recommendations are highly influential.

Therefore, the correct answer isB (Recommendations to stop a trial).

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.

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

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

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.

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.

21 CFR 54.2(f) & 54.4(a):Requires disclosure of “significant payments of other sorts” (SPOOS) that exceed$25,000or equity interests exceeding$50,000.

However,honoraria or consulting exceeding $10,000 annuallyalso trigger disclosure.

Thus, the reporting threshold is$10,000.

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.

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).

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.

Endpoint data collection is based onprotocol designand subject compliance, not CRF formatting.

ICH E6(R2) 4.9.0:Investigator responsible for data accuracy regardless of CRF complexity.

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).

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.

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.

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 thesponsor.

Minimal risk determination is a regulatory function of the IRB/IEC.

45 CFR 46.102(j):Defines minimal risk as harm or discomfort not greater than those ordinarily encountered in daily life.

45 CFR 46.109(a):The IRB has authority to approve, require modifications, or disapprove research, including assessment ofrisk level.

Investigators may propose a study as minimal risk, but only theIRB/IEC can formally classify it.

This ensures independent, unbiased evaluation of risk, protecting participants from investigator or sponsor bias.

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.

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).

Quality assurance (QA)is proactive and systematic, designed to prevent errors and ensure compliance.

ICH E6(R2) 1.46:Defines QA as “all those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements.”

Option A describes IRB responsibilities, Option C describesaudit, and Option D describes protocol approval processes. OnlyBaccurately matches the ICH definition of QA. QA is distinct fromquality control (QC), which is operational and focused on detection of issues during conduct.

Thus, the correct answer isB.

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.

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.

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).

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).

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.

Phase classification is based on study objectives, not just subject numbers.

Phase I:Focuses on safety, pharmacokinetics, dose-ranging, usually in healthy volunteers or small patient groups.

Phase II:Evaluateseffectiveness in patients with the conditionand monitors common short-term side effects.

Phase III:Confirms effectiveness in larger populations, compares to standard therapy, gathers more safety data.

Phase IV:Post-marketing studies exploring new indications, long-term safety, or special populations.

The given study aims toevaluate effectiveness and common short-term side effectsin 30 arthritis patients, which clearly aligns withPhase IIobjectives. It is not exploratory safety (Phase I), not confirmatory comparative (Phase III), nor post-marketing (Phase IV).

Thus, the correct answer isB (Phase II).

Investigators must document the receipt, use, return, or alternative disposition of investigational product (IP).

ICH E6(R2) 4.6.3:Requires investigators to maintain records of IP delivery, inventory, use by subjects, and return/disposition.

ICH E6(R2) 8.2.14–8.2.16:Essential documents include shipment records, accountability logs, and inventory records.

However,certificates of destructionare generated and retained by the sponsor (or authorized destruction facility), not required at the site unless the destruction occurred there. In this scenario, all IP was returned to the sponsor, so no destruction certificate would exist at the site.

Thus, the correct answer isD (Certificate of destruction).

Theprotocolmust 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 isD (Summary of nonclinical findings with clinical relevance).

TheInvestigator’s Brochure (IB)is updated by the sponsor to reflect new scientific or clinical information.

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

ICH E6(R2) 4.1.5:Requires the investigator to ensure staff are informed, but there isno requirementto notify IRB/IEC unless subject safety, rights, or risk profile is affected.

Since this update containedno changes related to subject safety, the investigator is not obligated to notify IRB/IEC, DSMB, or regulators. The updated IB must simply be filed in theregulatory binderand implemented at the site.

Thus, the correct answer isD (No notification is required).

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.