Module 5: Cellular Therapy Clinical Trial Framework | Minimizing Protocol Deviations by Jamie Wagner

Minimizing Protocol Deviations (Regulatory Compliance) highlights the importance of minimizing protocol deviations in cellular therapy clinical trials, discussing types of deviations, their implications on nursing operations, and strategies to avoid them, emphasizing the need for corrective and preventative actions and the continual optimization of protocols based on feedback.
Key messages:
· Protocol deviations in cellular therapy clinical trials can have significant implications for patient safety and data integrity.
· Key message: Collaboration between nursing staff and research teams, early involvement in protocol development, and ongoing training and optimization are essential for minimizing deviations and improving the overall clinical trial process.
Learning objectives:
1. Define different types of deviations in cellular therapy clinical trials and understand their implications for nursing operations.
2. Identify strategies to avoid deviations, including early involvement in protocol development, ongoing training, seeking feedback, and optimizing protocols based on experience and insights.
Find more resources here: bit.ly/2024-AlphaClinic-Nurse...
Learn more about CIRM: www.cirm.ca.gov
Learn more about the City of Hope Alpha Clinic: www.cityofhope.org/research/alpha-clinic

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