CT: Medical Writing: Protocols, Reports, Summaries, and Submissions

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

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9/26/2022 - 11/26/2022

$475

Online

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• SECTION ID:

  167373

• CLASS TYPE:

  Online Asynchronous.
  
  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.

• INSTRUCTOR:
  

  Paillard, Florence C, Scientific and Medical Writer for the biopharmaceutical industry

  Florence Paillard is a scientific and medical writer for the biopharmaceutical industry. Working within R&D, clinical and marketing fields, she acquired experience in writing many types of documents, from scientific and review papers to regulatory documents to marketing communications. She is currently a free-lance scientific and medical writer.

• TEXTBOOKS:

  No textbook required.

• POLICIES:

• NOTE:

  "***STUDENTS MAY ENROLL ANYTIME IN QUARTER, until OCTOB ER 11, 2022. Students must complete course by NOVEMBER 26, 2022, regardless of date of enrollment***Refund dea dline: one week after enrollment or start date of secti on, whichever is later.

• DATE & LOCATION:

  9/26/2022 - 11/26/2022
  extensioncanvas.ucsd.edu
  You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.