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. In this course, participants will discuss and practice the basic principles of clear medical writing and study the rules governing effective clinical trial documentation. Prerequisites: Medical Terminology, Drug Development Process, and GCP courses, or proven mastery of content.
Other Credits: BRN: 24 CE hours.
Note: Elective for Professional Certificate in Clinical Trials Design and Management.
Course Number: FPM-40188
Credit: 2.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management, Medical Writing