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Human Subject Research Regulatory - Rock Star Challenge

A professional setting with a diverse group of people in a meeting room discussing regulatory documents related to clinical research, with charts and compliance guidelines visible on a screen.

Human Subject Research Regulatory Challenge

Test your knowledge with our Human Subject Research Regulatory Rock Star Challenge! This quiz is designed for professionals involved in clinical research, compliance, and regulatory affairs. Whether you work at a research institution or are looking to expand your understanding of IRBs and CROs, this quiz is for you.

Ensure you’re up-to-date with the latest in human subject research regulations:

10 thought-provoking questions
Multiple choice and open-ended formats
Evaluate your readiness and compliance knowledge

10 Questions2 MinutesCreated by EngagingRegulator512

At the UFHCC CRO, where are follow-up monitoring letters sent?

[email protected], [email protected]

[email protected], Primary Study Coordinator, [email protected]

[email protected], Primary Study Coordinator, [email protected], Unit Manager

Based on the international standard for date notations, what format does the CRO use for approved regulatory documents?

2021-DEC-25

2021-12-25

2021-25-12

For the UFHCC CRO, in OnCore who is listed to receive IRB approvals?

PI, Primary Study Coordinator

IDS, Sponsor, PI

PI, Primary Study Coordinator, IDS, UFHCC Finance, Unit Manager

How many members must an IRB have?

What is the UF IBC?

A subject is enrolled on a study and the study coordinator realizes at a later date that the subject forgot to sign the ICF. Which of the following category does this fit into?

A. Adverse event

B. Protocol Deviation

C. Noncompliance

B & c

All of the above

Based on the FDA definition, what does ALCOA stand for?

What does the acronym sIRB stand for?

Who is required to sign an FDF?

What United States regulation required the establishment of institutional review boards (IRBs) to review human subjects research?

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