Needless to say that the COVID-19 pandemic has and still is impacting the way clinical trials are conducted. Local regulatory bodies offered guidance on behavioral and documentation expectations. As we go slowly back to a ‘new normal’, there are still many unknowns. Questions answered during this 30 minutes session are, amongst others: Are these alternative ways of working to stay or will we go ‘back to before’? What are acceptable and feasible ways to conduct remote monitoring/auditing? Is there an alternative for onsite SDV that is acceptable in the EU? Is the upcoming GCP E6 R3 standard supporting use of technology and alternative trial designs to weapon us again another disrupter like COVID-19?
Do join us, so we can shed some light on the darkness and help you be better prepared for the future.
By the end of this TRIUM Training you should be able to:
- Describe best practices in trial conduct post COVID-19 pandemic, ensuring subject safety and well-being, qualitative data and regulatory compliance
- List the key changes between GCP E6 R2 and GCP E6 R3
- Describe how GCP E6 R3 is supporting a new research framework that ensures better protection against disrupters like e.g. a virus pandemic
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.