Effective Leaders Don’t Settle for Being Managers

If you don’t know the difference between a manager and a leader, do yourself a favor and learn how to become the latter for the betterment of your career, your clinical trial colleagues, and your patients, says Karina Loyo, director of clinical researcher services at Prelude Dynamics. “Managers dish out assignments, and get the minimal […]

FDA Headquarters

FDA to Hold Public Meeting on Adverse Event eSubmissions Protocol Using ICH

The U.S. Food and Drug Administration (FDA) will hold its third and final public meeting February 19 at its White Oak Campus in Maryland designed to help illuminate industry on how to handle the electronic submission of adverse events using the International Council for Harmonization (ICH) E2B(R3) standards. Previous meetings were held last March and […]

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 […]