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.

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