Regulatory Compliance & Guidelines Flashcards
7 cards from real CRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Guidelines flashcards as text
A clinical investigator receives an honorarium from a pharmaceutical company whose drug they are studying. Under 21 CFR Part 54, this financial relationship must be:
Answer: Disclosed to the FDA as part of the financial disclosure certification
21 CFR Part 54 requires sponsors to certify or disclose investigators' financial interests to the FDA to allow assessment of potential bias in study data.
The Belmont Report identified three core ethical principles for human subjects research. Which of the following is NOT one of them?
Answer: Fidelity
The Belmont Report's three core principles are Respect for Persons, Beneficence, and Justice; Fidelity is not a Belmont principle.
Under ICH E6(R2), what must a sponsor do before transferring any trial-related duties to a Contract Research Organization (CRO)?
Answer: Establish a written agreement detailing the transferred duties
ICH E6(R2) requires a written agreement clearly delineating which sponsor duties are transferred to the CRO and which remain with the sponsor.
A sponsor conducting a Phase III trial wants to implement an unplanned interim analysis. Under ICH E9 statistical principles, which document should pre-specify the rules for early stopping?
Answer: The Statistical Analysis Plan (SAP)
ICH E9 requires that stopping rules and interim analysis plans be pre-specified in the Statistical Analysis Plan to maintain trial integrity and control Type I error.
Which of the following scenarios would most likely require submission of a Protocol Amendment to the FDA under 21 CFR Part 312?
Answer: Increasing the maximum dose of the investigational drug beyond what was previously approved
Changes that increase risk to participants, such as exceeding a previously approved dose, require a protocol amendment submitted to FDA before implementation.
Under the Revised Common Rule (2018), which category of research involving secondary use of identifiable data may qualify for exemption with limited IRB review?
Answer: Category 4 — secondary research with identifiable private information, with privacy safeguards
Exemption Category 4 under the 2018 Revised Common Rule covers secondary research with identifiable private information or biospecimens, subject to limited IRB review for privacy protections.
What is the primary regulatory purpose of an Investigational New Drug (IND) application submitted to the FDA?
Answer: To obtain permission to ship an investigational drug across state lines for clinical testing
An IND is required because shipping an unapproved drug across state lines is illegal; the IND grants an exemption allowing interstate shipment for clinical investigation.