Course description
An in-depth look at COA/eCOA strategies and tools, including ePRO, ClinRO and wearables/ sensors, including regulatory aspects and current hot topics (e.g., mixing modes, COVID-19 mitigation, data change requirements). Topics covered during the course will highlight the importance of PRO measurement to drive tailored, patient-centered clinical trials and support regulatory decision making.
This will include best practices for ePRO implementation, leveraging wearables for new endpoints to support labeling claims and regulatory thinking on BYOD.
This interactive course is recommended for those who have experience in clinical trials & patient engagement and wish to develop their skills on how PRO measurement is best implemented to advance patient care.
