Delving into eConsent: Industry Survey Reinforces Patient Centricity

Clinical Researcher—January 2020 (Volume 34, Issue 1) RECRUITMENT & RETENTION Neetu Pundir; Mika Lindroos; Jenna McDonnell; Bill Byrom; Spencer Egan   With the objective of learning more about the industry’s global experiences and perspectives with electronic informed consent (eConsent), Signant Health conducted a survey in 2019 that sought to obtain insights from more than 130 […]

The Data of Subject-Reported Adverse Events

Clinical Researcher—January 2020 (Volume 34, Issue 1) PEER REVIEWED Robert Jeanfreau, MD, CPI; Nathan Best   Attributes of the thorough documentation of research data, endorsed worldwide by the U.S. Food and Drug Administration (FDA), the International Council for Harmonization (ICH), and the World Health Organization (WHO), are embodied in the ALCOA acronym, first used by […]

Optimizing Medical Records Collection in Clinical Research: Lessons Learned from Two Pediatric Cohort Studies

Clinical Researcher—January 2020 (Volume 34, Issue 1) PEER REVIEWED Marina Albuquerque de Souza Dantas, MD; Lacey B. Robinson, MD; Elie Mitri; Catalina Gallegos; Ashley F. Sullivan, MS, MPH; Carlos A. Camargo Jr, MD, DrPH   Medical records are a valuable source of data for clinical research, and the ongoing shift to electronic medical records (EMRs) […]