Essential Documents and Documentation: Best

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Essential Documents and Documentation: Best Practices According to ICH GCP E6 (R2) Derita Bran, BSN, RN, CCRC Objectives Identify documentation necessary to conduct quality clinical trials Understand Essential Documents and their

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01
Essential Documents and Documentation: Best Practices According to ICH GCP E6 (R2) Derita Bran, BSN, RN, CCRC<br>
02
Objectives Identify documentation necessary to conduct quality clinical trials

Understand Essential Documents and their relationship to ICH GCP E6 (R2) guidance and requirements

Determine needed documentation & record keeping for your studies<br>
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Show of Hands Number of Audience conducting NIH trials
Number of Audience conducting Industry –sponsored trials
Other types of studies<br>