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ICH E6(R2) 5.5.3(g):Requires audit trails for any data changes, recording date, time, and person responsible.This ensures traceability and regulatory compliance.

Other restrictions (B–D) are not mandated under ICH.

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.

21 CFR 312.56(d):If an IND is withdrawn for safety, the sponsor must notifyFDA and all participating investigators, who in turn notify IRBs.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

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).

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).

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).

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).

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).

21 CFR 56.110(b):IRBs may use expedited review forminor changesin previously approved research.

Expedited review cannot be used for initial reviews of high-risk protocols or major modifications.

Correct answer isD.

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.

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 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 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.

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.

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.

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).

TheNuremberg Code (1947)established voluntary consent as essential following Nazi war crimes.

Helsinki (1964) built upon it; Belmont Report (1979) refined U.S. ethics.

Thus, the correct foundational WWII document isthe Nuremberg Code.

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.

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.

Children are avulnerable populationrequiring additional protections.

45 CFR 46.408(a):Requires “adequate provisions for soliciting the assent of the children, when in the judgment of the IRB, the children are capable of providing assent.”

45 CFR 46.402:Defines “assent” as a child’s affirmative agreement to participate.

IRBs must consider theage, maturity, and psychological stateof the children when determining assent capability.

Economic status (B) is irrelevant to assent. Physiological status (C) pertains to eligibility, not assent. Provider notification (D) may be local practice but not required by regulation.

Correct answer:A (Psychological status).

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.

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.

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.

Monitors verify compliance with protocol, sponsor SOPs, GCP, and regulations.

ICH E6(R2) 5.18.4:Outlines monitor responsibilities, including verifying informed consent, protocol compliance, investigational product accountability, and adherence to sponsor SOPs.

Monitors must also be familiar with subject-facing documents (A) and storage requirements for investigational product (B).

However,IRB/IEC requirements for reporting to regulatory authoritiesare outside a monitor’s scope. That responsibility lies with investigators and IRBs under21 CFR 56.108(b).

Thus, the correct answer isD.

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.

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.

Belmont Report:“Respect for Persons” incorporates two ethical convictions: treating individuals as autonomous agents and protecting those with diminished autonomy (e.g., prisoners).

Prisoners require special safeguards because of restricted liberty and potential coercion.

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).

TheFDA record retention requirementfor investigational drug studies is clearly outlined in21 CFR 312.57(c)and21 CFR 312.62(c).

21 CFR 312.57(c):“A sponsor shall retain the records and reports… for2 years after a marketing application is approvedfor the drug; or, if an application is not approved, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.”

21 CFR 312.62(c):Investigators also must retain study-related records for2 years following the date a marketing application is approvedor 2 years after the investigation is discontinued.

This requirement ensures FDA can audit investigational product data even after approval to confirm compliance and verify trial results. Longer retention (e.g., 15 years) may be institutional or sponsor policy but is not mandated by federal law.

Thus, the correct answer isA (2 years).

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.

TheInvestigator’s Brochure (IB)compilesclinical and nonclinical dataon an investigational product relevant to human study.

ICH E6(R2) 7.2.3:The IB should summarizenonclinical pharmacology, toxicology, pharmacokinetics, and efficacy data, including results of animal studies.

ICH E6(R2) 7.2.4:It should also includeavailable clinical trial dataand safety experience.

The “results of recent nude mouse study” (B) are nonclinical data, which appropriately belong in the IB. Lab draw requirements (A), dispensing instructions (C), and schedules of events (D) are operational/procedural and are found in theprotocol, not the IB.

Thus, the correct answer isB (Results of recent nude mouse study).

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.

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).

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.

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.

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.

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).

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).