CCRP Sample Questions Answers

ICH E6(R2) 5.5.12 & 8.1:Essential documents must be retained2 years after the last approval of a marketing application in an ICH region and until no applications are pending, or2 years after discontinuation of development.

This ensures availability for inspection.

21 CFR 56.109(a):IRBs must review all changes to informed consent before implementation.

ICH E6(R2) 4.8.2:If new information could affect willingness to continue, consent forms must be revised and approved by the IRB.

Even though screening is closed, the IRB/IEC must review the updated form before any subject re-consenting.

21 CFR 312.56(d):If an IND is withdrawn for safety, the sponsor must notifyFDA and all participating investigators, who in turn notify IRBs.

Ensures subjects are protected and sites stop enrollment.

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.

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.

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).

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.

Even if a study does not involve drugs, devices, or biologics, it still involveshuman subjectsand therefore requiresethical review by an IRB/IEC.

45 CFR 46.109(a):“An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy.”

ICH E6(R2) 3.1.2:“The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects.”

Quality-of-life (QOL) studies may involve surveys, interviews, or questionnaires, but since they involve human participants, they are subject to human research protection regulations. FDA involvement is not required unless drugs or devices are tested. Similarly, HHS approval is not required unless the study is federally funded.

Thus, the correct answer isC (The IRB/IEC).

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.

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.

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.

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 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).

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.

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).

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.

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).

420 subjects ÷ 42 months (3.5 years) =10 subjects/month.

However, “expected average” often rounds up to next whole number, ensuring enrollment goals are met. Thus,11/monthis correct.

This calculation is important for feasibility assessments and protocol planning.

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

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

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.

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).

21 CFR 312.57(c):“Sponsors shall retain records for2 years after a marketing application is approvedor if not approved, 2 years after shipment and delivery of investigational drug for investigation.”

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).

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 areinformed consent forms(to confirm subject protection) andinvestigational product documentation(to confirm reconciliation and disposition).

Correct answer:D.

Investigators are required to maintain accurate subject records, often referred to ascase histories.

21 CFR 312.62(b):“An investigator shall prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation.”

ICH E6(R2) 4.9.0:Reinforces that investigators are responsible for recording, handling, and storing clinical trial data.

Incorrect options:

B: Investigators may present protocols but cannot vote on IRB approval.

C: Sponsor responsibility (ICH E6 §5.18).

D: Sponsors are responsible for IB updates (ICH E6 §7.3.1).

Correct 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.

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).

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).

AnInvestigational Device Exemption (IDE)allows an unapproved medical device to be used in aclinical investigation.

21 CFR 812.1(a):“An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would otherwise apply.”

It does not allow commercial sale (B), non-study clinical use (C), or marketing as a humanitarian device (D).

Thus, the correct answer isA (Shipped lawfully for clinical study).

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).

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).

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 anFDA violation.

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.

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.