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.

The informed consent document (ICD) is a cornerstone of ethical clinical research, ensuring voluntary participation and protection of subject rights.

21 CFR 50.25(a):Requires the consent form to containall basic elements, including study purpose, risks, benefits, alternatives, confidentiality, compensation, and voluntariness.

ICH E6(R2) 4.8.10:Expands on these requirements, ensuring the ICD contains every mandated element without omission.

Thus, the correct statement is that the ICDmust include all applicable mandated basic elements(D). Options A and B confuse who signs—subjects or legally authorized representatives sign when applicable, not the IRB chair. Option C is incorrect because leaving out elements would violate compliance.

Correct answer:D.

Serious adverse events are subject to expedited reporting requirements.

ICH E2A 3.2.2:“Fatal or life-threatening unexpected ADRs should be reported as soon as possible but no later than7 calendar daysafter first knowledge.”

ICH E2A 3.2.3:Other serious unexpected events must be reported within 15 days.

Thus, the 7-day rule applies tolife-threatening and unexpected events(as in this case).

Correct answer:B (7 days).

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.

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.

21 CFR 312.23(a):Requires cover sheet, CMC information, and IB.

Financial disclosureis required separately under21 CFR 54, not part of IND content.

21 CFR Part 11governs the use of electronic records and electronic signatures in FDA-regulated research.

21 CFR 11.10(a):Requires “validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.”

Validated systems ensure equivalency between electronic and paper records.

While access controls (D) are also mandated, they arepart of system validation, not the defining requirement. Printing/signing paper copies (A) is unnecessary under Part 11. Entry into an eCRF (C) is just one function, not sufficient for compliance.

Thus, the correct answer isB (Managed within a validated computer system).