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 researcher is conducting a study that was previously granted a waiver of informed consent. The study protocol is then modified to collect identifiable information. What must the researcher do?
Answer: Submit a protocol amendment and obtain a new or revised IRB determination on the waiver
Any change that affects the basis for a waiver of informed consent requires IRB review via a protocol amendment before implementing the change.
Under 45 CFR 46 Subpart B, which of the following research involving pregnant women may be conducted even when it offers no direct benefit to the pregnant woman?
Answer: Research presenting minimal risk to the pregnant woman and the fetus
Subpart B permits research on pregnant women presenting no more than minimal risk to the pregnant woman and the fetus, even without direct benefit.
A multi-site clinical trial uses a central IRB (cIRB) for review. Under the 2018 Revised Common Rule, which of the following is TRUE regarding cIRB use for domestic sites?
Answer: A single cIRB review is required for domestic cooperative research under the Revised Common Rule
The 2018 Revised Common Rule mandates that domestic sites cooperating in multi-site research rely on a single IRB unless an exception is granted.
Which FDA guidance document provides recommendations on the content and format of the Investigator's Brochure (IB)?
Answer: ICH E6(R2) — Good Clinical Practice Guideline
ICH E6(R2) provides detailed guidance on the content, format, and required updates for the Investigator's Brochure used in clinical trials.
A subject enrolled in a clinical trial later becomes incapacitated due to a stroke. The study requires continued data collection from the subject's medical records. Under ethical guidelines, the research team should:
Answer: Seek permission from the subject's legally authorized representative (LAR) before continuing
When a participant loses decision-making capacity during a study, the LAR must be approached to provide permission for continued participation or data collection.
Under 21 CFR Part 312.62, how long must investigators retain clinical study records after the investigation is discontinued or completed?
Answer: 2 years following the date that the FDA approves the marketing application (NDA/BLA), or 2 years if no application is filed
21 CFR Part 312.62 requires investigators to retain records for 2 years after the FDA approves the NDA/BLA or, if no application is filed, 2 years after the investigation is discontinued.
Which of the following best describes the role of the Office for Human Research Protections (OHRP) in the US research regulatory framework?
Answer: OHRP provides oversight and policy guidance for the Common Rule (45 CFR 46) and investigates compliance issues at institutions receiving federal support
OHRP oversees implementation of the Common Rule at institutions receiving federal funding and investigates alleged noncompliance with human subjects protections.