Documentation and Document Management

Clinical research documentation involves a variety of documents from various sources and is authored by several individuals. We will first look the general purpose of clinical care documentation and then focus on clinical research documentation. It is important to understand that a subset of this documentation ill be used for data collection and analysis. This overview module is divided into 2 required components and 1 recommend video. Once you have completed all required parts, 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:

 Part 1Documentation in Clinical Research (23 minutes)

Part 1 Handout

Resources  Evaluation  
 Part 2Regulatory File  (20 minute)Part 2 Handout
Regulatory File Checklist