Clinical Research Operations

 Documentation and Document Management

Clinical research documentation involves a variety of documents from various sources and is authored by several individuals. This overview module is divided into 1 required video. Once you have completed the required part, please link to the evaluation after which you will be directed to a certificate of completion for your education records.

Module Objectives

At the conclusion of this module, learners will be able to:

• Describe best practices for clinical research documentation.
• Define source documentation.
• Discuss how to handle discrepancies among various source documents.
• Describe the purpose of the regulatory file/binder.
• List the essential elements of the regulatory file/binder.
• Describe when it is appropriate to centralize essential documents.