The ascent of the Physician-Sponsored Investigational Device Exemption (PS-IDE) clinical trial has shifted roles and responsibilities for many professionals, says Yuki Kuramochi, BSN, RN, a clinical project manager with the […]
Clinical Researcher—February 2019 (Volume 33, Issue 2) PEER REVIEWED Linda S. Behar-Horenstein, PhD; Lissette Tolentino; Huan Kuang; Wajeeh Bajwa, PhD; H. Robert Kolb, RN, MS, CCRC In response […]
Opinion: Appreciating a Clinical Approach to the Evaluation of Nonserious, Laboratory Adverse Events
Clinical Researcher—February 2019 (Volume 33, Issue 2) PEER REVIEWED Robert Jeanfreau, MD, CPI Recognizing the ongoing necessity for mitigating bias and improving the quality of reporting randomized […]
Clinical Researcher—February 2019 (Volume 33, Issue 2) SPECIAL FEATURE Ann Neuer, MBA The subject of adverse events (AEs) is often summed up as a series of definitions […]
Clinical Researcher—February 2019 (Volume 33, Issue 2) SPECIAL FEATURE Robert Barton The U.S. Food and Drug Administration’s (FDA’s) proposed rule to allow an institutional review board […]