Our own Sandra “SAM” Sather is a contributing author for the HIPAA Privacy Rule and FDA Regulated Clinical Trials chapter, which extensively answers questions about protection of privacy during clinical research. The reference guide answers more than 1000 common questions related to US and international Good Clinical Practice (GCP) for clinical trials. An example of updated content in the chapter includes the answer to, “What has changed recently under HIPAA to support remote review of PHI?” Additional new content in the guide includes:
Impacts to clinical trials post ICH E6 R2 addendum
EU Directive updates
Updates to the “Common Rule”
Latest inspection finding trends
The book can be purchased from Barnett International here.
- The Clinical Pathways Team
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