This all day workshop aims to provide clinical trials research professionals with a targeted update on GCP and as well the guidance on obligations and roles in the new era of risk-based monitoring in clinical trials. The training will be highly interactive with numerous workshops and case studies to support the theory covered.
The first half of the day will be a Risk-Based Monitoring workshop facilitated by Quintiles. The second half of the workshop will be delivered by Sophie Mepham from Peter MacCallum on the Trancelerate accredited Introduction to Good Clinical Practice (GCP) Program aimed at those working in clinical trials.
The program will include sessions on:
- Risk-based Monitoring: The New Regulatory Landscape, and Conjectures on the Future of Clinical Trial Execution
- Data-Driven Trial Execution (DTE) studies and implementation
- DTE and budgeting
- Alignment with site needs
- GCP – the standards
- Study set up
- Informed Consent
- CRF and data entry
- Safety reporting