Elements of Clinical Research
10 videosA free ten-part video series for the Ophthalmic Clinical Research Coordinator, covering the clinical trial lifecycle, ethical principles in human research, regulation, trial initiation and conduct, clinical data, and documentation practices including ALCOA and monitoring.
Reference Section
Module 4
Natural History
FDA Guidance: Rare Diseases — Natural History Studies for Drug Development
Real World Evidence
Module 5
Nuremberg Code
[“Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10”, Vol. 2, pp. 181–182. Washington, D.C.: U.S. Government Printing Office, 1949.]
Belmont Report
Declaration of Helsinki
World Medical Association: Declaration of Helsinki
International Conference on Harmonization Good Clinical Practice (ICH GCP)
Module 6
Code of Federal Regulations for Clinical Trials
FDA: Regulations, Good Clinical Practice, and Clinical Trials
CITI Program
CITI Program: Good Clinical Practice (GCP) Course Series
Institutional Biosafety Committee Guidance Document
NIH: Institutional Biosafety Committee Guidance Document (PDF)
Module 8
Endpoints
Frequently Asked Questions
How long does the Elements of Clinical Research course take?
The full ten-part video series runs about two hours and eight minutes in total. Individual modules range from about four to twenty-two minutes, so you can watch the whole series in one sitting or work through it a module at a time.
How is the course structured?
The series is organized into ten sequential video modules covering the role of the clinical research coordinator, the clinical trial lifecycle, pre-clinical research, types of research, ethical principles in human research, how trials are regulated, how trials are initiated and conducted, clinical data and electronic case report forms, and documentation, ALCOA and monitoring.
Is the Elements of Clinical Research course free?
Yes. The entire ten-part series is free to watch, with no account, sign-up or payment required.
Who is this course for?
This course is designed for ophthalmic clinical research coordinators, ophthalmic technicians, and other clinical site staff who support ophthalmic clinical trials and want a grounding in both the ophthalmology and clinical research sides of the work.
Do I need to watch the modules in order?
The series is designed to build sequentially from Module 1 through Module 10, but each module is independently selectable from the playlist, so you can jump straight to a specific topic if you already have a foundation in the earlier material.