I would like to introduce you to Barnett's newest publication, HIPAA and U.S. Clinical Trials: A Question & Answer Reference Guide 2014 that I authored.
This guide can support clinical trial stakeholders, including sponsors, contract research organizations (CROs), investigators or delegates, institutional review boards (IRBs), and research subjects. This Guide includes the regulatory changes and updates from 2003 to present.
Some of the key items covered include:
- Common misunderstandings of the requirements of the HIPAA Privacy Rule regarding clinical trials Monitoring electronic health records (EHRs) under HIPAA
- Defining covered entities and hybrid entities
- Authorizations and Clinical Trial Agreements mapping to ensure access to pertinent data
- The use of Review Preparatory to Research to support subject enrollment
- Changes to the requirements of Business Associates
- Compound and Future HIPAA Authorizations
- The 2014 HIPAA and U.S. Clinical Trials: Question & Answer Reference Guide will be ready to ship mid April.
For questions or to order your copy today call: 1-800-856-2556 or email: email@example.com.