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Operationalizing the Serious Adverse Event (SAE) Process at Clinical Research Sites

by SOCRA | Jul 19, 2021 | Clinical Research, Monitoring, Project Management, Protocols, quality management, Trial Management

Tracy Popp, MBAPreviously: Director, Research Financial Operations Norton Healthcare, Inc.Currently: Senior Director of Clinical Research, Tampa General Hospital Abstract: It is important for clinical research sites to operationalize the serious adverse event (SAE)...

Adding it up to Create the Perfect Balance: Advanced Site Management Tools

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...

Evaluating the Protocol: Can the Clinical Research Site Really Do this Study?

by SOCRA | Mar 5, 2019 | Protocols

Monika Gaa, MBA, CCRP Senior Feasibility Coordinator, Nationwide Children’s Hospital Christine Baker, BA, CCRP Senior Regulatory Coordinator, Nationwide Children’s Hospital Abstract: Protocol evaluation is critical to determining the feasibility of a study. This...

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Promoting excellence in clinical research professionals through education, CCRP® certification, and community, leading to ethical, high-quality research, protection of participants, and global health improvement since 1991.