CRS Clinical Research Regulations Flashcards

Phase I clinical trials primarily assess which of the following?

Answer: Safety, tolerability, and dosage

Phase I trials focus on evaluating the safety, tolerability, and appropriate dosing of a new intervention in a small group of participants.

What does 21 CFR Part 11 regulate in the context of clinical research?

Answer: Electronic records and electronic signatures

21 CFR Part 11 sets FDA requirements for the use of electronic records and electronic signatures in regulated clinical studies.

An unexpected, fatal serious adverse event (SAE) in a clinical trial must be reported to the FDA within how many calendar days?

Answer: 7 days

Unexpected fatal or life-threatening serious adverse events must be reported to the FDA within 7 calendar days of the sponsor's knowledge.

Which document outlines the objectives, design, methodology, and statistical considerations of a clinical trial?

Answer: Study Protocol

The study protocol is the master document that describes the scientific rationale, objectives, and procedures for conducting a clinical trial.

What is the role of a Sponsor in a clinical trial as defined by federal regulations?

Answer: To take responsibility for initiating, managing, and financing the trial

The Sponsor is the entity that initiates, manages, and bears overall responsibility for the design, conduct, and regulatory compliance of a clinical trial.

The Belmont Report established which three core ethical principles for human subjects research?

Answer: Respect for persons, beneficence, and justice

The 1979 Belmont Report identified respect for persons, beneficence, and justice as the foundational ethical principles governing human subjects research.