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 Clinicaltrials.gov (US) and EudraCT (EMA). Students will learn the legal and ethical basis for disclosure of clinical trial protocol and results, a comprehensive overview of Clinicialtrials.gov and EudraCT, processes for protocol and results summarization and release for Clinicaltrials.gov and EudraCT, review of other mandatory international registries and systems, and workflow for operationalizing clinical trial disclosures.
CLINICAL PROGRAMMING
These introductory courses walk the aspiring programmer through high-level concepts related to clinical programming in the life science industry.
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PHARMACOVIGILANCE
These courses offer entry level medical professionals the fundamentals of medical coding and its application in clinical trial data sets.
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MEDICAL WRITING
These courses are for the clinical and regulatory focused individuals in the pharmaceutical industry and allow you to apply your skills to almost any regulatory document.