In clinical research, the protocol outlines the inclusion/
exclusion criteria stating who is and isn’t eligible for the
trial, what procedures will be performed, the timing and
frequency of visits, the endpoints being measured, and other
details necessary to assess the study. The protocol needs to
be prescriptive to uniformly manage and assess the science
behind the study.
Access our BPD Playbook to learn more about corresponding guidance standardizing and centralizing the process for the
recruitment and retention of participants.