CT: Documents in Drug Development: Writing Protocols, Reports, Summaries, Submissions, and Disclosures
FPM-40685
No clinical trial can begin until a protocol has been written, and no clinical trial is complete until the final report is assembled, signed, and submitted to the FDA. Good documentation for clinical trials must be clear and scientifically sound, and it must conform to instructions. This course provides an overview of key regulatory documents; their central purpose and content; and the regulations and/or procedures that govern them. Students will also have the opportunity to review, write, and discuss different aspects of regulatory documents. The course is intended for individuals who want to start or further a career in clinical research as most members of a clinical research team are asked to write, review, or edit these regulatory documents.
Course Information
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This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Textbooks:
No textbook required.
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Instructor:
Yeshi Mikyas
Dr. Yeshi Mikyas has 23 years experience in different areas of clinical trial conduct (academic and industry setting), with 16 years specifically in Medical Writing. She earned her BSc in Biology and PhD in Molecular Biology and Medical Pharmacology from UCLA. Her Medical Writing experience includes the preparation of regulatory and safety documents, and journal articles, reviews, abstracts, and presentations. Yeshi is currently the Senior Director, Medical Writing at Pfizer overseeing the preparation of regulatory documents for submission and disclosure. She has been involved with the UCSD Extension Medical Writing program since 2015, and has led the Regulatory Writing Capstone since its first offering in 2017. She is passionate about empowering and encouraging medical writers to be strong effective partners within their teams.
