General References
General references
OHRE Standard Operating Procedures
Human Subject Regulations Decision Charts – 2018 requirements
NIH U.S. National Library of Medicine: Medline Plus
Acronyms used on the IRB Forum (and in the “IRB world” in general)
Setting up a Strong Social Media Recruitment Program for Clinical Trials
Radioactive Drug Research Committee – Human Research Without an IND Application
“Recontacting Pediatric Research Participants for Consent When They Reach the Age of Majority.” IRB: Ethics & Human Research 38.6 (2016)
Webinar information
Webinar: FDA Oversight and IRB Review of Studies that Include In-Vitro Diagnostics
- Documents: PRIMR IVD Webinar Handouts and In vitro Final Guidance
Webinar: OHRP NPRM webinar link
Webinar: Clinical Trials – Reporting Obligations for Investigators
Webinar: “Is your site FDA inspection ready?”