Authoring Clinical Documents

  • Duration: 12 weeks
  • Commitment: 8-10 hours per week
  • Price: US $2,995
  • Class mode:  Live & Interactive/Instructor-led
  • Certificate of Achievement: Evidence your learning with a Certificate of Achievement from Medical Writing University on successful completion.
  • Start: July 8, 2024
  • Finish: September 24, 2024
  • Enroll by: June 14, 2024

Course Overview

Participants will explore the clinical development process and learn how to efficiently author clinical documents including clinical study reports (CSRs) and 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 reports and protocols in the pharmaceutical industry.

Although much of the course will center on the authoring CSRs and protocols participants will also go beyond to explore statistical analysis plans, 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 documents
  • To assess medical writing strategies as a CSR and protocol author
  • To initiate, author, and finalize a CSR and protocol
  • To understand the importance and how to interpret and analyze clinical trial data for the purpose of authoring clinical reports and protocols
  • To understand the importance of patient safety and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) in clinical document 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