Protocol Consultation
Regulatory Knowledge and Support provides protocol consultation
The science behind the background and procedures of a protocol are best described by the principal investigator; however, there may be regulatory and ethical issues relevant to the study of which the research team may not be aware.
These domains are the expertise and the primary perspective provided by Regulatory Knowledge and Support, having operational implications which may pertain to inclusion/exclusion criteria, identification and recruitment of human subjects, the consent process and document, and study monitoring.