by SOCRA | Oct 9, 2019 | Investigational Drugs and Devices (IDE/IND)
Sarah Attwood, BScDirector of Client ServicesIntegReview IRB Abstract: Institutional review boards (IRBs) continue to be overburdened with reports not required by federal regulations. It is important to understand the difference between what the regulations require...
by SOCRA | Aug 29, 2019 | pediatric clinical research
Lauren Bird, RN, BSN, CCRCClinical Research Nurse Mallory Rowell, MS, CCRCClinical Research Coordinator The Research Institute at Nationwide Children’s Hospital Abstract: Maintaining respect for the autonomy of families enrolled in pediatric clinical trials is a...
by SOCRA | Aug 9, 2019 | Protocols
Christina Talley, MS, RAC, CCRP, CCRC Houston Methodist Research Institute, Office of Strategic Research Initiatives Abstract: Detailed protocol analysis and feasibility objectively translated into a protocol grade or quantitative score is an effective way to manage...
by SOCRA | Jul 25, 2019 | Monitoring
Jane Ferguson, RN, MN, CCRP Senior CRA, Westat Abstract: Targeted monitoring is the on-site component of risk-based monitoring and focuses on the aspects of clinical research that have the most potential to impact participant safety and the credibility of the study’s...
by SOCRA | Jul 18, 2019 | quality management
Vatché BartekianPresident, Vantage BioTrials, Inc. Abstract: Quality by design for clinical trials comprises an independent entity responsible for quality standards and an integrated system where each person is accountable for quality. This article explores myths...
