Physician-Sponsored Clinical Trials Demand New Skillsets

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 Cleveland Clinic. A physician who is acting as a sponsor-investigator both initiates and actually conducts, alone or with others, a drug or device study. “It’s […]

Wake Forest Baptist Health and Wake Forest University Join ACRP ‘Partners in Workforce Advancement’ Initiative

The Association of Clinical Research Professionals (ACRP) welcomes Wake Forest Baptist Health and Wake Forest University to the ACRP ‘Partners in Workforce Advancement’ (PWA) initiative. PWA is a groundbreaking new initiative to expand the clinical research workforce by bringing together a broad coalition of clinical research stakeholders focused on creating a sustainable workforce for the […]

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 […]