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.
Students will be tested on their ability to draft and submit a disclosure. This exercise will prepare them to be a functional member of the clinical trial disclosure team within a CRO or pharmaceutical industry.
This is an ideal course for the detail-oriented, regulatory-focused and compliance-minded scientist or student with a pharmaceutical industry focus.
A total of 18 weeks is needed for completing the program.
A BS in the life sciences field, graduate level education is preferred. Experience in pharma is a plus.
Completion of a minimum of three years academic coursework in a life science or health science field, or permission of the instructor.
Knowledge checks will be performed through a quiz in every session. Evaluation of written reports will be performed through multiple assignments/exercises and will conclude with a final examination. A minimum of 75% is required to pass the final examination.
* Degrees or diplomas from educational institutions outside the United States must be equivalent to degrees from U.S. educational institutions.