What are the advantages of setting up a chairperson study assessment?

A chairperson study assessment can expedite the study start-up process because it allows the sponsor and a member of the Board to address possible issues and to answer questions before the study is reviewed by the full Board. Some examples of when a chairperson study assessment may be appropriate are, if the sponsor is proposing a complex trial design, trying to decide if a placebo arm is appropriate within a given population or trying to establish the right age range of participants, or other design or consent form related questions. Obtaining feedback early in the process often helps simplify the post-review negotiations and minimizes Board modifications.