Authoring Clinical Study Protocols

  • Duration: 6 weeks
  • Commitment: 8-10 hours per week
  • Price: US $1,995
  • Class mode: Instructor-led
  • Certificate of Achievement: Evidence your learning with a Certificate of Achievement from Medical Writing University on successful completion.
  • Start: 13 November 2023
  • Finish: 19 December 2023
  • Enroll by: 06 November 2023
  • Upcoming Information Session: 30 October 2023

Course Overview

Participants will explore the clinical development process, where medical writing documents fit into the development strategy, and how to efficiently author clinical study protocols. This medical writing course concentrates on the competencies and practices in the field of clinical and regulatory medical writing related to authoring clinical study protocols (Phase 1 to Phase 3) in the pharmaceutical industry. Therapeutic areas of oncology, immuno-oncology, infectious disease, and autoimmunity will be emphasized.

Although much of the course will center on the authoring of clinical study protocols participants will also go beyond protocol authoring to explore standard clinical trial processes and drug/biologic development in the biotech and pharmaceutical industries.

Relevant medical writing course projects will be drawn from a range of applications to give context to conceptual information and participants will be encouraged to apply their learning to their own work through discussions and medical writing project work.

What Will I Learn?

  • To recognize the role of the medical writer in authoring clinical study protocols
  • To assess medical writing strategies as a clinical study protocol author
  • To initiate, author, and finalize a clinical study protocol
  • To understand the importance of patient safety and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) in the protocol authoring process

Who Is This Course For?

This course is suitable for:

  • Professionals who are new to the field of medical writing
  • Individuals who are transitioning into the field of medical writing from a closely related field (i.e., regulatory affairs, scientist, pharmacist, or clinician)
  • Medical writers who want to broaden their skill set to enhance their career opportunities
  • Individuals who hold an advanced degree (PhD, PharmD, or MD [RNs will be allowed to enroll on a case-by-case basis]). *PhD postdocs are encouraged to apply