PHAR 432 Introduction to Trial Disclosure

This course provides background perspective and technical skill sets for facilitating workflow and summarizing data to meet global trial disclosure requirements. Ever-evolving regulatory requirements have the industry catching up to maintain compliance. Outsourcing is increasing, and the skills required to comply with disclosure requirements are in high demand. This course will provide hands-on experience with writing and reporting to global registries with a focus on ClinicalTrials.gov (United States) and EudraCT (European Medicines Agency). Students will learn the legal and ethical basis for clinical trial disclosure (protocols and results). Students will also be provided with a comprehensive overview of ClinicalTrials.gov and EudraCT; the processes for protocol and results summarization and release to ClinicalTrials.gov and EudraCT; legal requirements for other mandatory international registries and systems; and a standard workflow for operationalizing clinical trial disclosures.

Credits

1

Prerequisite

Permission of the instructor