Conducting Clinical Trials in Canada Inspections of Clinical Investigators

by SOCRA | Jun 14, 2021 | Clinical Research, clinical research regulations, Compliance, FDA

Mike M. Rashti President, BIMO Auditor and Trainer, LLC Abstract: This article provides an overview of the U.S. Food and Drug Administration’s (FDA’s) foreign inspection program and the Bioresearch Monitoring Program as it is applied to inspections in Canada. How to...

Clinical Trials Day 2021: A Time for Celebration and Reflection

by SOCRA | May 5, 2021 | Clinical Research, Clinical Trials Day, SOCRA Member Highlights

May 20th  marks Clinical Trials Day (CTD), an international commemoration of James Lind’s launch of the scurvy clinical trial on May 20, 1747, which would form the foundation for modern clinical research. Celebrated for the first time in 2005, CTD raises clinical...

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...

How to Motivate and Retain Clinical Research Staff

by SOCRA | Mar 10, 2021 | Clinical Research, Professional Development, Project Management, Training

Takisha Adair, Clinical Operations Manager, Covance Abstract: Retaining staff is challenging for clinical research organizations. Motivating employees and engagement can help reduce staff turnover. Organizational leaders who desire to retain a talented workforce...

Utilization of Cancer Registrars in Clinical Research

by SOCRA | Feb 3, 2021 | Cancer Research

Rossio Y. Rodriquez, HIM, CTR Director, Data Management Proton Collaborative Group What is a Cancer Registrar? A cancer registry is the information system designed for the collection, management, and analysis of data on a person’s diagnosis that contains...

Clinical Research Studies During the COVID-19 Pandemic Public Health Emergency

by SOCRA | May 13, 2020 | Clinical Research, clinical research regulations, COVID-19

Defining a “New Normal” in Clinical Research to Support the World’s 336,747 Research Studies By: Jennifer Goldfarb – MSN, RN, CCRP As of April 21, 2020, according to clinicaltrials.gov, there were 336,747 research studies registered by organizations in all 50...