CT: Documents in Drug Development: Writing Protocols, Reports, Summaries, Submissions, and Disclosures

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.