Trial Disclosures

Introduction to Trial Disclosures

This one-of-a-kind course provides background perspective, and technical skill sets for facilitating workflow and summarizing data to meet global trial disclosure requirements.

This new regulatory requirement has the industry catching up to maintain compliance. Outsourcing is increasing and the skills required to meet disclosure requirements are in high demand. This course will provide hands-on experience with writing and reporting to global registries with a focus on (US) and EudraCT (EMA). Students will learn the legal and ethical basis for disclosure of clinical trial protocol and results, a comprehensive overview of and EudraCT, processes for protocol and results summarization and release for and EudraCT, review of other mandatory international registries and systems, and workflow for operationalizing clinical trial disclosures.

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