CCRP SOCRA Certified Clinical Research Professional (CCRP) Free Practice Exam Questions (2025 Updated)

Theprotocolgoverns all trial conduct, including whether subjects should be replaced when they withdraw.

ICH E6(R2) 6.0:The protocol must contain “detailed information on trial design, methodology, statistical considerations, and the organization of the trial.”

ICH E6(R2) 6.9.2:The section on “Subject withdrawal or discontinuation” specifies “whether and under what conditions subjects may be replaced.”

Other documents serve different functions: the DSM plan (A) manages safety oversight, the IB (C) summarizes product background, and the consent form (D) explains subject rights but does not guide study conduct. Only theprotocolprovides the operational answer regarding replacement.

Thus, the correct answer isB (The protocol).

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.

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).

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.

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.

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.

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

Before applying broadly,IRB approvalmust be obtained.

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.

Theinvestigatoris directly responsible for ensuring that the IRB/IEC reviews and approves the research both initially and on a continuing basis. This responsibility is not delegable to the sponsor or study staff.

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, consent form updates, 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.”

This means that while the sponsor submits documents to the FDA and oversees general compliance, theinvestigator has the obligation to obtain and maintain IRB approvalat their site. The monitor or study coordinator may assist in documentation, but legal responsibility rests with the investigator.

Thus, the correct answer isC (The investigator).

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.

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).

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.

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).

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.

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.

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).

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.

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).

Theprotocol signature pagedocuments agreement between the sponsor and the investigator/institution to conduct the trial in compliance with ICH GCP, the protocol, and regulatory standards.

ICH E6(R2) 8.2.2 (Signed protocol and amendments):Requires “the sponsor and investigator/institution to sign the protocol and amendments, confirming agreement.”

ICH E6(R2) 4.5.1:“The investigator should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, approved by the regulatory authority(ies) and by the IRB/IEC.”

The sponsor–investigator signatures ensure shared accountability for subject protection, data integrity, and adherence to trial methodology. Neither delegated staff (B) nor IRB/IEC (C) nor FDA (D) sign protocols. These bodies approve or oversee, but do not formally enter into execution of the protocol.

Thus, the correct answer isA (The investigator/institution and the sponsor).