The Investigator’s Brochure (IB) compiles clinical and nonclinical data on an investigational product relevant to human study.

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

ICH E6(R2) 7.2.4: It should also include available clinical trial data and 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 the protocol , not the IB.

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

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 follow sponsor’s written procedures for reconciliation, return, or destruction, not IRB or pharmacy processes.

An Investigational New Drug (IND) application provides 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 under 21 CFR Part 54 , not as part of the initial IND. Export applications (A) are covered under 21 CFR 312 Subpart E . Profit sales (C) are not permitted under INDs.

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

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 are informed consent forms (to confirm subject protection) and investigational product documentation (to confirm reconciliation and disposition).

Correct answer: D.

Sponsor audits ensure systems comply with GCP.

ICH E6(R2) 5.19.3: “The sponsor’s auditing procedures should include a review of quality 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).

ICH directs investigators to document and explain any deviation, with prompt reporting to IRB/IEC only when deviations are implemented to eliminate immediate hazards or as required. Exact extracts:

ICH E6(R2) 4.5.3: “ The investigator should document and explain any deviation from the approved protocol.”

ICH E6(R2) 3.3.7 & 4.5.2 (paraphrased): deviations to eliminate immediate hazards must be reported as soon as possible. Here, absent immediate hazard, the required action is documentation and explanation (B).

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.

Source data are original records where data are first recorded .

ICH E6(R2) 1.51: Defines source data as “all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.”

Since subjects directly enter responses into the EDC, the EDC record itself is the original source document . EMRs (B, C) and printouts (D) are secondary records.

Correct answer: A (The EDC record).

The FDA has authority to impose clinical holds and terminations on IND studies when subject safety is at risk.

21 CFR 312.44(b)(1): “The FDA may propose to terminate an IND if it finds that human subjects would be exposed to an unreasonable and significant risk of illness or injury.”

21 CFR 312.42(e): “If an IND is placed on clinical hold and the deficiencies have not been adequately addressed within 30 days, FDA may terminate the IND.”

Annual reports (A) are required but noncompliance usually results in clinical hold, not immediate termination. IRB approval delays (B) do not trigger termination; the site simply cannot begin. Investigators report safety data to sponsors, not directly to FDA (C).

Thus, the correct answer is D (The FDA issued a clinical hold, and 30 days have elapsed) .