What Doesn’t Kill You Makes You Do More Paperwork

Clinical Researcher—January 2020 (Volume 34, Issue 1) PI CORNER Christine Senn, PhD, CSM, CCRC, CPI, ACRP-CP, FACRP   Explorations into another person’s job are always eye-opening experiences. I have fostered my self-perception of being a generalist in clinical research by spending a year or more embedded in most departments found in clinical research sites—particularly regulatory, […]

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 […]