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How to Design a Clinical Study: Principles and Protocol Development

Hybrid (on demand videos and live virtual sessions) course on the design & implementation of clinical studies

Course Syllabus

Table of Contents

Course Dates:

Course Dates:

This course runs twice per year in the spring and fall. For details on the next iteration of this course, please visit the overview page.

Course Website

Course Website

When registered for the course, you will be provided a personalized username and password that allows you to sign-in.

Presenter

Course Directors:

Naomi Fisher, MD | Associate Professor of Medicine, Brigham and Women’s Hospital

Course Topics

Pre-Course Work
1 week

Unit 1: Research Design & Methods
2 weeks

Unit 2: Statistical Analysis & Anticipated Results
3 weeks

Unit 3: IRB & Ethics
2 weeks

Unit 4: Data Management
1 week

Course Conclusion
1 week

Participant Expectations

The course is designated for a maximum of 26.25 AMA PRA Category 1 Credits™ which are earned through completing course activities; including watching attending and participating in all virtual live sessions, watching all online video lectures and assessments, submitting each protocol draft by the deadline over the duration of this nine-week course.

Throughout the course, participants are required to attend six mandatory virtual sessions.

Completing the Course

Each participant is eligible for a Statement of Completion upon viewing all course lecture videos and completing course assignments.

CME Credit: The Harvard Catalyst Education Program is accredited by the Massachusetts Medical Society to provide continuing medical education for physicians.

The Harvard Catalyst Education Program designates this enduring material for a maximum of 26.25 AMA PRA Category 1 Credits™.

Physicians should claim only the credit commensurate with the extent of their participation in the activity. In order to receive CME credits, participants must complete 100% of the course by the final course deadline. Completion of the course includes the following:

  • Attend and participate in all face-to-face/virtual sessions
  • Watch online videos and complete assessments by the unit due date
  • Submit protocol drafts by the due date

Eligible participants may request Statements of Completion/CME Credit through the end of the course evaluation survey, which is part of the course conclusion via the course website.