by SOCRA | Dec 24, 2019 | Training
Anatoly Gorkun, MD, PhD, Assoc CIPDSenior Manager Scientific and Compliance Training, MedImmune Abstract: Different professional training techniques can be used to achieve training goals. This article describes how to deliver efficient training sessions that benefit...
by SOCRA | Dec 20, 2019 | clinical research regulations
James F. Bush, Esq. [1] Abstract In 2018, the European Union’s General Data Protection Regulation (“GDPR”) came into full force and effect. With the growth of international multi-center clinical research studies, U.S.-based research organizations and investigators...
by SOCRA | Nov 19, 2019 | Monitoring
Joanne Malia Associate Director, Clinical Documentation Management Regeneron Pharmaceuticals Abstract: Regulatory agencies are advocating for sponsors to take risk-based approaches in various clinical trial-related activities, especially in the area of...
by SOCRA | Nov 8, 2019 | Good Clinical Practice (GCP)
Amy Waltz, JD, CIPAssociate Director – Regulatory Affairs, Reliance, Outreach Indiana University Abstract: Understanding context is key to understanding the regulations and complying with regulatory requirements. This article explores the historical context and...
by SOCRA | Oct 28, 2019 | quality management
Abby Statler, MPH, MA, CCRPResearch Regulatory Quality Assurance CoordinatorCleveland Clinic Cancer Institute Abstract: In 2008, The Cleveland Clinic Cancer Institute established a quality assurance (QA) program for investigator-initiated trials (IITs). Over the past...
