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

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).

ICH E6(R2) 5.13.3:The sponsor is responsible for the supply, storage, and final disposition of investigational product.

21 CFR 312.59:Sponsors must assure return or proper disposition of unused supplies.

Sites must followsponsor’s written proceduresfor reconciliation, return, or destruction, not IRB or pharmacy processes.

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

After three years, no disclosure is required.

21 CFR 812.35(a)(2):Allows deviation without prior approval only to eliminate immediate hazards.

Before applying broadly,IRB approvalmust be obtained.

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.

IRBs/IECs must retain records to permit evaluation of compliance.

ICH E6(R2) 3.4.2:“IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for at least3 years after completion of the trial.”

Extended retention (B–D) may occur institutionally, but ICH minimum is3 years.

Correct answer:A (At least 3 years).

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.

21 CFR Part 11governs the use of electronic records and electronic signatures in FDA-regulated research.

21 CFR 11.10(a):Requires “validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.”

Validated systems ensure equivalency between electronic and paper records.

While access controls (D) are also mandated, they arepart of system validation, not the defining requirement. Printing/signing paper copies (A) is unnecessary under Part 11. Entry into an eCRF (C) is just one function, not sufficient for compliance.

Thus, the correct answer isB (Managed within a validated computer system).

ICH E6(R2) 5.5.3:Sponsors are responsible for validating computerized systems used in trials.Investigators ensure proper data entry, but system compliance lies with sponsor.

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.

Consent forms must present information inlanguage understandable to the subject, avoiding technical jargon.

21 CFR 50.20:“The information… shall be understandable to the subject… and not include any exculpatory language.”

ICH E6(R2) 4.8.6:Information should be presented inlanguage non-technical and understandable to the subject.

Thus, while medical terms (myalgia, arthralgia) are precise, they may not be understandable to laypersons. The correct format useslayman’s terms: “muscle aches, joint pain, and tiredness” (B).

Correct answer:B.

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.

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).

This question tests drug accountability and dosing calculation, which is central to ICH E6(R2) 4.6 (Investigational product management). Subjects must receive the correct supply and any discrepancy must be reconciled.

The prescribed regimen is 2 mg twice daily = 4 mg per day. With 1 mg tablets, this equals 4 tablets daily. Over 10 days, the subject should consume 40 tablets (4 × 10 = 40). Since 45 tablets were dispensed, the subject should have 5 tablets remaining after 10 days.

Accurate accountability ensures trial integrity and subject safety. Investigators are responsible for maintaining investigational product (IP) records, including dispensing, usage, and returns. According to ICH:

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.”

4.6.5: “The investigator should ensure that investigational products are used only in accordance with the approved protocol.”

Thus, the correct answer is C (5 tablets remain). This reflects proper dosing compliance and highlights the importance of meticulous IP tracking in clinical trials.

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.

TheBelmont Report (1979)establishedthree 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 embodiesRespect 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 isB (Respect for persons).

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 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.

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 innew or broader populationsbeyond original approval.

While dosing and schedules are Phase I–III, Phase IV focuses onnew patient populationsor long-term outcomes.

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.

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.

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.

ICH E6(R2) 3.1.2 & FDA Recruitment Guidance (1998):Recruitment materials must be reviewed by IRB to ensure no coercion or misleading claims.

CRFs and storage plans are sponsor/site tools, not IRB-reviewed documents.

For IRB/IEC submissions, investigators must disclose subject-related information that may impact voluntariness or fairness of participation.

21 CFR 56.111(a)(3):The IRB must ensure that subject selection is equitable.

21 CFR 50.25(a)(3):Requires disclosure of “any compensation and/or medical treatments available if injury occurs.”

ICH E6(R2) 4.8.10(n):Informed consent should describe “any compensation and/or reimbursement to subjects.”

Thus,compensation amountsmust be reviewed by IRB/IEC to ensure they are not coercive or excessive. Budgets (A), marketing plans (C), and contracts (D) are administrative and not part of IRB submission requirements.

Correct answer:B (The amount of payments and compensation to subjects).

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

Sponsor is then responsible for notifying FDA and all investigators.

21 CFR 312.32(c)(1)(ii):Sponsors must notifyall participating investigatorsof any serious and unexpected suspected adverse reactions.

Investigators then inform IRBs and subjects as appropriate.

AnInvestigational New Drug (IND) applicationprovides FDA with data to justify human testing.

21 CFR 312.23(a)(3):The IND must contain “a description of the general investigational plan, including the rationale for the drug or the research study.”

The IND also includes preclinical safety data, manufacturing details, investigator qualifications, and study protocols.

Financial disclosures (D) are reported separately under21 CFR Part 54, not as part of the initial IND. Export applications (A) are covered under21 CFR 312 Subpart E. Profit sales (C) are not permitted under INDs.

Thus, the correct answer isB (Rationale and plan for human testing).

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.”

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 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.

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).

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).

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).

The investigator has ultimate responsibility for site staff qualifications.

ICH E6(R2) 4.2.4:“The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product, and their trial-related duties and functions.”

ICH E6(R2) 4.1.5:Investigator must maintain current documentation of staff qualifications.

While sponsors and monitors oversee compliance, accountability rests with theclinical investigator. Coordinators may implement duties, but do not hold legal responsibility.

Correct answer:B (The clinical investigator).

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.

Serious adverse events are subject to expedited reporting requirements.

ICH E2A 3.2.2:“Fatal or life-threatening unexpected ADRs should be reported as soon as possible but no later than7 calendar daysafter first knowledge.”

ICH E2A 3.2.3:Other serious unexpected events must be reported within 15 days.

Thus, the 7-day rule applies tolife-threatening and unexpected events(as in this case).

Correct answer:B (7 days).

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).

FormFDA 1572is 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 withFDA 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 under21 CFR 54) or preclinical data (in theIB).