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NEW QUESTION # 65
A monitor is conducting a site closeout visit. The study site kept electronic medical records and source documents in a system verified to be 21 CFR Part 11 compliant. The monitor reviewed all electronic documents by logging into the system with a unique login ID and password. In addition to the essential document file, which of the following sets of documents should be provided to the monitor during the study closeout visit?
- A. Informed consent documents and printouts of electronic source documents
- B. Informed consent documents and investigational product documentation
- C. Printouts of electronic source documents and the remaining investigational product
- D. A copy of the final report for the IRB and investigational product shipment records
Answer: B
Explanation:
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.
References:
ICH E6(R2), §8.1, §8.4.
NEW QUESTION # 66
In accordance with the ICH GCP Guideline, prior to initiating a trial, which of the following should define, establish, and allocate all trial-related duties and functions?
- A. The sponsor
- B. The IRB/IEC
- C. The institutional administrator
- D. The study coordinator
Answer: A
Explanation:
* 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.
References:ICH E6(R2), §5.2.1.
NEW QUESTION # 67
Which of the following entities, if any, must provide an approval before an investigator may enroll subjects in a quality-of-life research questionnaire study?
- A. The FDA or another regulatory authority
- B. The IRB/IEC
- C. The Department of Health and Human Services
- D. No approvals are necessary if no pharmaceutical drugs are involved
Answer: B
Explanation:
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).
References:
45 CFR 46.109(a) (IRB review of research).
ICH E6(R2), §3.1.2 (IRB/IEC role in subject protection).
NEW QUESTION # 68
A physician with 20 years of experience is planning to be the site investigator for a multi-center, Phase I oncology clinical trial. In accordance with the ICH GCP Guideline, which of the following documents should the physician provide to the sponsor and the IRB/IEC?
- A. A curriculum vitae
- B. Proof of citizenship
- C. A letter of recommendation from a fellow physician
- D. A copy of medical license
Answer: A
Explanation:
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).
References:
ICH E6(R2), §4.1.1 (Investigator qualifications).
ICH E6(R2), §8.2.10 (Essential documents: CV).
NEW QUESTION # 69
An investigator's responsibilities for conducting clinical trials include:
- A. Observing preclinical drug effects
- B. Maintaining IRB meeting minutes
- C. Maintaining financial documentation for study staff
- D. Administering or overseeing investigational drug administration
Answer: D
Explanation:
* 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.
References:ICH E6(R2) §4.6.1; 21 CFR 312.61.
NEW QUESTION # 70
In accordance with the ICH GCP Guideline, who is responsible for ensuring that all study site personnel working on a clinical trial are qualified to conduct the trial?
- A. The study monitor
- B. The clinical investigator
- C. The clinical research coordinator
- D. The sponsor
Answer: B
Explanation:
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).
References:
ICH E6(R2), §4.2.4.
ICH E6(R2), §4.1.5.
NEW QUESTION # 71
According to ICH GCP, sponsor-specific essential documents must be retained until:
- A. 3 years after last approval
- B. 5 years after last approval
- C. 2 years after last approval and no pending applications
- D. 25 years after last approval
Answer: C
Explanation:
* 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.
References:ICH E6(R2) §§5.5.12, 8.1.
NEW QUESTION # 72
Which case history documents must be at both sponsor and site?
- A. Case report forms (CRFs)
- B. Signed informed consent forms
- C. Medical records
- D. Study visit notes
Answer: A
Explanation:
* ICH E6(R2) 1.11:CRFs are documents used to record protocol-required data reported to sponsor.
* Sites keep originals; sponsor retains copies.Consent forms and medical records stay at site only.
References:ICH E6(R2), §1.11.
NEW QUESTION # 73
In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?
- A. Overseeing the administration of the investigational drug to the subjects
- B. Ensuring that the FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug
- C. Maintaining case histories that record all observations and other data pertinent to the investigation
- D. Submitting progress reports to the reviewing IRB/IEC
Answer: B
Explanation:
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).
References:
21 CFR 312.55(b) (Sponsor notification requirements).
NEW QUESTION # 74
If a subject experiences a serious adverse event related to the study drug and only minimal information is available, the investigator must submit the information to the:
- A. Sponsor and IRB/IEC within seven days
- B. Sponsor and IRB/IEC within five days
- C. Sponsor and IRB/IEC immediately, then update later
- D. IRB/IEC immediately, then sponsor when full details are available
Answer: C
Explanation:
* ICH E6(R2) 4.11.1:Investigators must "immediately report all serious adverse events to the sponsor except for those the protocol identifies as not requiring immediate reporting."
* IRB must also be informed promptly per21 CFR 312.64(b).
* Follow-up information is submitted later as available.
References:ICH E6(R2), §4.11.1; 21 CFR 312.64(b).
NEW QUESTION # 75
According to 21 CFR Part 11, each electronic signature must be unique and:
- A. Reassignable after validation
- B. Cannot be reused or reassigned
- C. Transferable to family
- D. Identical to handwritten signature
Answer: B
Explanation:
* 21 CFR 11.100(a):Requires that electronic signatures be "unique to one individual and shall not be reused or reassigned to anyone else."
* This ensures accountability and audit trail integrity.
References:21 CFR 11.100(a).
NEW QUESTION # 76
A Phase I clinical trial is initiating. Who is responsible for ensuring that site staff are adequately informed about trial duties?
- A. Clinical investigator
- B. Program manager
- C. IRB/IEC
- D. Sponsor
Answer: A
Explanation:
* ICH E6(R2) 4.2.4:"The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, investigational product, and trial-related duties."This responsibility cannot be delegated to sponsor or IRB.
References:ICH E6(R2), §4.2.4.
NEW QUESTION # 77
In accordance with the ICH GCP Guideline, when a sponsor transfers trial-related duties andfunctions to a contract research organization (CRO), who is ultimately responsible for the quality and integrity of the trial data?
- A. The sponsor
- B. The investigator
- C. The CRO
- D. The IRB/IEC
Answer: A
Explanation:
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.
References:
ICH E6(R2) Good Clinical Practice, §5.2.1 (Sponsor/CRO).===========
NEW QUESTION # 78
A subject has creatinine 1.6 mg/dL, slightly above eligibility (#1.5). Investigator believes this is normal for size. When can subject be enrolled?
- A. After repeat test confirms 1.6
- B. After sponsor revises eligibility and IRB approves amendment
- C. After investigator documents explanation in chart
- D. After monitor approves deviation
Answer: B
Explanation:
* ICH E6(R2) 4.5.1:"The investigator should conduct the trial in compliance with the protocol approved by IRB/IEC."
* Deviations must not occur unless to eliminate hazard. Eligibility criteria cannot be overridden by investigator opinion.
Thus, enrollment requires protocol amendment and IRB approval.
References:ICH E6(R2), §4.5.1.
NEW QUESTION # 79
A sponsor is permitted to charge for an investigational drug but must provide what documentation?
- A. Orphan product evidence
- B. IRB attestation of institutional cost burden
- C. Evidence of potential clinical benefit and significant advantage
- D. CMS approval letter
Answer: C
Explanation:
* 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.
References:21 CFR 312.8(b).
NEW QUESTION # 80
Which of the following is one of the responsibilities of an investigator?
- A. Maintaining accurate and current case histories of study subjects
- B. Selecting qualified monitors on the basis of training, experience, and expertise
- C. Participating in the IRB/IEC voting process for approval of their protocol
- D. Updating the investigator brochure with new safety information
Answer: A
Explanation:
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.
References:
21 CFR 312.62(b).
ICH E6(R2), §4.9.0.
NEW QUESTION # 81
Upon completion of a study, the investigator should do which of the following?
- A. As soon as possible, provide the IRB/IEC with a final report that summarizes the trial's outcome
- B. Provide the IRB/IEC a final report, but only if the study has a positive outcome
- C. Ensure that all payments from sponsor have been received
- D. Compile site data, publish the study results, and submit the publication to the IRB/IEC as the final report
Answer: A
Explanation:
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).
References:
ICH E6(R2), §4.13.2 (Final reporting requirement).
NEW QUESTION # 82
The study coordinator for a new Phase III vaccine study is preparing documents for IRB/IEC submission.
According to the ICH GCP Guidelines, which of the following documents should be included in the submission?
- A. The investigators' CVs
- B. Recruitment materials
- C. Case report forms
- D. Local lab normal ranges
Answer: B
Explanation:
IRBs/IECs are responsible for ensuring that subject recruitment is ethical and not coercive.
* ICH E6(R2) 3.1.2:The IRB/IEC safeguards subjects by reviewing recruitment procedures and materials.
* 21 CFR 56.111(a)(3):Requires equitable subject selection, which extends to advertisements and recruitment.
* FDA Guidance on Recruiting Study Subjects (1998):States that "advertisements and recruitment materials must be reviewed and approved by the IRB prior to use." While CVs (D) and lab ranges (A) are essential documents for study feasibility and quality, they are not mandatory for IRB approval package. CRFs (B) are sponsor tools for data collection, not subject-facing, and thus not reviewed by IRBs.
Correct answer:C (Recruitment materials).
References:
ICH E6(R2), §3.1.2.
FDA Recruitment Guidance, 1998.
NEW QUESTION # 83
A study will enroll 420 subjects over 3.5 years. What is expected average monthly accrual?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: A
Explanation:
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.
References:Standard feasibility calculations (ICH E6(R2) §5.6).
NEW QUESTION # 84
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