Maintaining the Human Touch in Clinical Research

Clinical Researcher—March 2019 (Volume 33, Issue 3) EXECUTIVE DIRECTOR’S MESSAGE Jim Kremidas New technologies are impacting the clinical trial landscape in ways almost unimaginable 20 years ago. Whether it’s widespread use of wearable devices, remote monitoring, artificial intelligence, or the promise of virtual trials, we’re clearly on the verge of revolutionary change where the very […]

Show Me the Documentation

Clinical Researcher—March 2019 (Volume 33, Issue 3) RESEARCH COMPLIANCE Jan S. Peterson, MS, CCRA, RAC, ASQ CBA, ACRP-CP Q: My institution is currently in the process of amending its standard operating procedure (SOP) for CITI Program training. We have been having trouble keeping key personnel compliant, and are wondering what the federal requirement is for […]

Assessing the Impact of Online GCP Training on CRC Perceptions of Adverse Events

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 to the growing complexities of clinical research as it converges with new technologies and regulatory intricacies, the International Council for Harmonization (ICH) published the Integrated […]

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 controlled trials (RCTs), the SORT Group, comprised of medical journal editors, researchers, and epidemiologists, in 1994 published A proposal for structured reporting of randomized controlled […]

A Fresh Take on the Adverse Event Landscape

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 and reporting requirements, but more recently, there has been an effort to breathe life into this unwieldy topic, bringing greater understanding to the role of […]