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.
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 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.
