Training Program Title
Preparing the Study Specific Documentation
Training Program Description
This module describes the study-level documentation expected at Duke. It describes the regulatory binder, documents required for all studies, documents required for most studies, and documents that are required depending on the type of study. It discusses standard operating procedures. This module provides guidance for creating the binder or file, maintaining central files, and what should not be included in the documentation to be audit ready.
Documentation, Essential documents, Regulatory binder, Source documents
Digital Commons Disciplines
Cost to Access
Clinical Research Professionals (other than PI)