Good Clinical Practice (GCP)

Tools and Techniques for Effective Clinical Research Start-up at an Academic Medical Center

by SOCRA | Apr 1, 2021 | Clinical Research, Good Clinical Practice (GCP), Study start-up

Michael Mapel, CCRPClinical Research LeadUCLA Pediatrics Office of Finance & Research Children’s Discovery & Innovation Institute1 Abstract: Activating a clinical research project at an academic medical center requires significant planning and effort from...

The Changing Landscape of Human Subjects Research

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...

Similarities and Differences Between Good Laboratory Practice and Good Clinical Practice

by SOCRA | Jan 25, 2019 | Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

Milton V. Marshall, PhD, DABT, CCRP, President, Marshall & Associates Abstract: Preclinical testing of investigational pharmaceuticals, medical devices, and biologics is necessary before human subjects can be exposed to them. Many similarities exist...

What is the Purpose of GCP Training? A Quality Management Perspective

by SOCRA | Nov 27, 2018 | Good Clinical Practice (GCP)

Graeme Downes, Senior Director, Clinical and PV QA, AstraZeneca Anatoly Gorkun, Senior Manager, Scientific and Compliance Training, MedImmune Abstract: The Good Clinical Practice (GCP) regulations require that each individual involved in conducting a clinical trial be...