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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 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.

This is adrug/device accountability calculation question, testing compliance with investigational product tracking.

The subject was instructed to perform4 glucose checks per day.

Over10 days, that equals40 tests (4 × 10 = 40).

Each test requires1 strip, so40 strips used.

Subject was given45 strips, leaving5 unusedafter 10 days.

Investigators are responsible for maintaining accurate device/product accountability.

ICH E6(R2) 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.”

This ensures monitoring can confirm that product/device use aligns with the protocol and subject adherence.

Thus, the correct answer isB (5 unused test strips).

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.

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.

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).

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).

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.

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.

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).

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.

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.

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).

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.

For non–sponsor investigators, responsibilities are limited tosite-level conduct and product accountability.

ICH E6(R2) 4.6.1:“Responsibility for investigational product(s) accountability at the trial site rests with the investigator/institution.”

21 CFR 312.61:Requires the investigator to administer investigational drugs only to subjects under their supervision and maintain control.

Other responsibilities listed belong tosponsors:

A: Reporting SAEs to FDA is a sponsor duty (investigators report to sponsor, not directly to FDA).

B: Monitoring at all sites is a sponsor responsibility.

C: Disseminating safety updates is a sponsor’s role.

Correct answer:D (Maintaining control of IP).

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 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) 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.

Before an investigator can commit to conducting a trial, they must review thestudy protocol.

ICH E6(R2) 4.5.1:The investigator should conduct the trial in compliance with theprotocol approved by the IRB/IEC and sponsor.

ICH E6(R2) 4.2.3:The investigator should be thoroughly familiar with the appropriate use of the investigational product as described in the investigator’s brochure and the current approved protocol.

Although resources, training, and equipment are important, the fundamental step is provision of theprotocol, which forms the legal and ethical framework for study conduct. No trial agreement can be finalized until both parties agree on theprotocol details.

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.

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).

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.

Drug storage conditions are essential to maintaining investigational product (IP) integrity. According to ICH:

ICH E6(R2) 5.13.3:“The sponsor should ensure that investigational products are stored… under appropriate conditions as specified by the sponsor and in accordance with applicable regulatory requirement(s).”

ICH E6(R2) 4.6.4:“The investigator/institution should store the investigational product(s) as specified by the sponsor (and in accordance with applicable regulatory requirement(s)), and ensure that product(s) are used only in accordance with the approved protocol.”

During site qualification/selection, the monitor evaluates storage conditions — particularlytemperature ranges— to ensure the site can meet the stability requirements for the IP. Factors like staff numbers, space, and cost are operational considerations but not regulatory determinants of site qualification.

Thus, the correct answer isC (Storage facility temperature range). This ensures compliance with sponsor specifications, product stability, and ultimately subject safety.

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.

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.

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

Before applying broadly,IRB approvalmust be obtained.

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.

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) 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.

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.

This scenario falls underemergency use of investigational drugs without informed consent.

21 CFR 50.23(a):Allows waiver of informed consent if subject faces a life-threatening condition, available treatments are unproven, and immediate use is required.

21 CFR 50.23(a)(3):Requires that “the determination… be reviewed and concurred with by a physician who is not otherwise participating in the clinical investigation.”

Thus, anindependent physician(not part of the trial team) must certify the necessity of emergency investigational use.

Sponsors and monitors (C, D) are not authorized by regulation to make such determinations. Sub-investigators (A) lack independence and would be conflicted.

Correct answer:B (Independent physician).

When a trial ends at a site, the investigator has an obligation to submit a final report to the IRB/IEC. This is outlined in both ICH and CFR:

ICH E6(R2) 4.13: “Upon completion of the trial, the investigator should provide the IRB/IEC with a summary of the trial’s outcome.”

21 CFR 312.66: Requires investigators to “report to the IRB all changes in the research activity and all unanticipated problems involving risk, and to provide reports at the end of the study.”

The final report provides closure and documentation that the study was conducted ethically and in compliance with regulatory standards. Other documents listed in the options (monitoring reports, DSMB summaries, subject logs) may be retained by the sponsor or site, but they are not mandated for IRB submission.

Thus, the correct answer is A (Final Report). This ensures the IRB/IEC has an accurate record of study completion, outcome, and compliance with ethical oversight.

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

After three years, no disclosure is required.

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.

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).

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).

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.

IRBs must be diverse and independent to protect human subjects.

21 CFR 56.107(d):“Each IRB shall include at least one member whose primary concerns are in nonscientific areas… andat least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person affiliated with the institution.”

There is no minimum requirement of seven members (A). Nonscientists must be represented but not a majority (B). Clergy are not mandated (C). The critical safeguard is inclusion of at leastone unaffiliated member (D)to ensure independence.

Thus, the correct answer isD (At least one unaffiliated individual).

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).