Applied Clinical Trials

Bridging Clinical Research and Clinical Health Care Collaborative to launch

Wednesday, June 14, 2017

In 2018, the Bridging Clinical Research and Clinical Health Care Collaborative will bring together industry leaders from pharma, biotech, CROs, healthcare organizations, advocacy groups and the FDA to advance the participation of patients and physicians in the conduct of clinical trials. The conference will be April 4–5, 2018, at the Gaylord National Resort and Conference Center in National Harbor, Maryland.

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OHRP/FDA offer final guidance on electronic informed consent

Saturday, April 1, 2017

On December 15, 2016, the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS) and the FDA published final guidance aimed at providing answers to commonly asked questions about using electronic informed consent (eConsent)in clinical investigations. The guidance applies to “electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.”1 This guidance finalizes the draft guidance Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers that was issued in March 2015. The final guidance was developed in collaboration with FDA and OHRP and is issued as a joint final guidance.

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