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Clinical Researcher—July 2021 (Volume 35, Issue 5) SPECIAL FEATURE Sean Horkheimer, JD, CIP When recruiting participants for a clinical trial, the U.S. Department of Health and Human Services (HHS) regulations require that “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether […]
Clinical Researcher—July 2021 (Volume 35, Issue 5) SPECIAL INTERVIEW Gary W. Cramer with Alison Holland and Pamela Tenaerts, MD, MBA In this special interview with thought leaders on clinical research processes from Medable, we concentrate on how clinical trials team members and technology trends are catching up to each other in the pursuit of […]
Clinical Researcher—July 2021 (Volume 35, Issue 5) SITES & SPONSORS Bree Burks, RN, MSN How can research site staff manage patient consent efficiently if they are required to use a different system for each study? Learning and using multiple consenting solutions is difficult and adds complexity to research operations, leading sites to rely on […]
Clinical Researcher—July 2021 (Volume 35, Issue 5) SCIENCE & SOCIETY Al O. Pacino; Matthew Chandler With the successful expediting of clinical research for COVID-19, many have questions about the future of clinical research compliance. The challenges of adhering to U.S. Food and Drug Administration (FDA) requirements and new regulations regarding the protection of personal […]
Clinical Researcher—July 2021 (Volume 35, Issue 5) PRESCRIPTIONS FOR BUSINESS Donvan Quill Rare diseases affect 1% or less of the global population, with the geographic spread and small number of those impacted making the cost of research and development (R&D) prohibitive and leaving patients without treatments. Of the 7,000 known rare diseases, 95% […]
