This lecture provides an overview of protocol writing and development for investigators conducting human subject research. Topics covered include protocol purpose, audience-appropriate communication through writing, scientific design, and protocol organization with a content discussion of each protocol section.
In this course, participants will learn the process for developing an effective Corrective and Preventive Action Plan (CAPA). It will cover when and why CAPAs are needed, ways to identify a root cause, and tools to facilitate the process.
This training will provide an introduction to human subjects research regulations; the differences between Exempt, Expedited, and Full Board reviews; and an introduction to human subject research involving vulnerable populations.