Michelle Esplin Research Scientist HCI Research Compliance Office
Lyna Saffell Clinical Site Monitor PS Internal Medicine Administration
The purpose of this class is to provide you with the requirements for source documentation
based on applicable regulations. These requirements and the collection of clinical
research data for investigator-initiated studies, as well as research sponsored by
industry and government, will be presented. How to properly document data and prepare
forms to serve as source documents will be described. Examples of templates and forms
will be provided.
At the conclusion of this class, you should be able to:
Recognize regulations, guidelines, and standards that apply to source documentation
Identify which documents are necessary as source documents in research data collection
Determine how to properly document acquired data
Create required forms that will serve as source documents and transfer source data
to Case Report Forms if appropriate.