Office for Human Subjects Protection Core Training - Module 9 Essential Documentation

The goal of the core training modules is to cultivate an advanced understanding of research topics. This is module 9 in a series of 10 learning modules. Each of the modules in this series covers a different topic area.

Learning Objectives
  1. Define essential documentation and determine what type of documentation must be maintained, based on the nature of the research
  2. Differentiate between source documentation and study documentation
  3. Apply best practices in developing and maintaining study documentation
  4. Summarize good documentation practices
Clinical trial operations
Study and site management
Data management and informatics
Time Required
1 hour
Delivery Method
This content was originally submitted to the Development, Implementation, and Assessment of Novel Training in Domain-based Competencies (DIAMOND) project. DIAMOND is a collaborative effort by the University of Michigan, University of Rochester, The Ohio State University, and Tufts University to provide a nationally crowd-sourced, federated, online catalog for practitioners to find and contribute training and assessment materials. If you have questions or have updated information regarding this content, please email

Submitted by CLIC Admin on Sun, 01/10/2021 - 23:11 . Last modified on 02/18/2021