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

Operationalizing Serious Adverse Event Process

Tracy Popp, MBA
Previously: 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) process beyond regulatory and clinical. Norton Healthcare, Inc. has developed policies and a workflow for operationalizing SAEs, including clinical, legal, billing, accounting, and budgeting capture. This article provides an overview of the way in which Norton Healthcare has done this as well as how other sites can also operationalize SAEs.

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

Christina Talley, MS, RAC, CCRP, CCRC

Houston Methodist Research Institute, Office of Strategic Research Initiatives

a clinical research working on a tablet

Abstract: Detailed protocol analysis and feasibility objectively translated into a protocol grade or quantitative score is an effective way to manage overall workload distribution, personnel resource allocation, and financial management before the clinical trial is implemented. This article provides an overview of protocol areas for evaluation, scoring, and current effort tracking models used in clinical research. One model, the Protocol Acuity Rating Scale (PARS), is described in detail with examples of its application to different types of clinical research studies

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

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 article describes the key elements for evaluating protocols for financial feasibility, recruitment, and practical application. Strategies that have worked well at Nationwide Children’s Hospital are highlighted.

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