Every study should have a regulatory binder or file whether survey research or drug/device clinical trials. There is a standard set of documents referred to as “essential documents” that should be filed and maintained in the regulatory binder. In this session, we will discuss regulations applicable to documentation, which documents are considered essential, how these documents should be stored, for how long and where.
Pamela Richtmyer - Director, MGB Human Research Affairs Compliance & Education
Kathy Vernovsky - MGB Human Research Affairs Compliance & Education