Elements of Clinical Research

10 videos

A 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

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/rare-diseases-natural-history-studies-drug-development

Real World Evidence

https://www.fda.gov/science-research/science-and-research-special-topics/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

https://www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_FINAL.pdf

Declaration of Helsinki

https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/doh-oct2008/

International Conference on Harmonization Good Clinical Practice (ICH GCP)

https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf

Module 6

Code of Federal Regulations for Clinical Trials

https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials

CITI Program

https://about.citiprogram.org/series/good-clinical-practice-gcp/

Institutional Biosafety Committee Guidance Document

https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf

Module 8

Endpoints

https://toolkit.ncats.nih.gov/glossary/endpoint/