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.
This course will discuss the PI's additional responsibilities when COMIRB is serving as sIRB, explain the process and procedures for COMIRB, the PI, and the relying sites, and explain when and how the Smart IRB network is used for this purpose.
This training will cover the steps involved in recruitment, discuss national studies that have had high enrollment and retention rates, and the regulations surrounding recruitment.
