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Posted by John Lehmann on Wed, Mar 04, 2015

The Silver Lining to the Sunshine Act

With many articles covering the facts or even the looming uncertainty concerning the Sunshine Act, it was nice to come across an article that could see the silver lining in the cloudy post-sunshine days. The article, “The Bright Side of the Sunshine Act” mentions some of the pros of the Final Rule on the Sunshine Act. Where is the silver lining?

Topics: Sunshine Act, Patient Protection and Affordable Care Act, HHS

Posted by John Lehmann on Wed, Mar 04, 2015

NEW: Guidance Regarding HIPAA and De-identification

Public trust is critical to ensure quality research, as research depends on volunteers who trust that their private information will not be inappropriately or unnecessarily disclosed. Trust encourages research participants to communicate honestly and openly with researchers. There are many specific topics that fall under the rubric of privacy and confidentiality that are essential to consider by those involved in any aspect of clinical research.

Topics: HHS, De-identification, HIPAA

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Clinical Research Training Requirements
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clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.