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.
Download our whitepaper below to learn more about corresponding guidance standardizing and centralizing the process for the recruitment and retention of participants.