Metrics are used to ensure conclusive study results and to anticipate and mitigate the risk of trial delay. With the development and utilization of the right metrics, potential risks can be identified in time to revise your approach and put corrective actions into place. This webinar will discuss the use of operational and study quality metrics to monitor the progress of a clinical trial from start-up to study closure.
What You’ll Learn
Attendees will be able to:
1. Explain the differences between operational and study quality metrics.
2. Describe the importance of cross functional shareholders in the development of metric reporting.
3. Identify what key aspects of a clinical trial would be monitored.
4. Explain how metrics can be used to monitor key aspects of data in relation to critical study objectives.
5. Describe how metrics can improve the quality of study data.
Meet the Presenter
Donna Gugger is currently Director, Clinical Data Management at United BioSource Corporation, and has 25 years Data Management experience. Her background includes multiple therapeutic areas for phase I-IV clinical trials, registries, observational studies, and Risk Evaluation and Mitigation programs.
Kindra Grozinger is a Clinical Data Manager at United BioSource Corporation (an Express Script company) in Data Management operations. In this position, she leads an expert team of Data Analyst and Data Entry operators who are well versed in eCRFs and paper CRF trials on multiple platforms. Her background includes multiple therapeutic areas including device, musculoskeletal, dermatology, gastroenterology, hematology, oncology, and neurology for phase I-IV clinical trials, registries, observational studies, and Risk Evaluation and Mitigation programs.
Who Should Attend
Intermediate and experienced CDMs, CRAs and biostatisticians.
Participants are eligible to receive CEUs upon attendance and successful completion of assessment questions.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.