The IRB

How does our IRB work?
Tab 3 - IRB OPERATIONS
Times, Decisions, Guides,
and other logistical things.

Please call with any questions.

3.01. IRB OPERATIONS
Rosters Old and New,
Review times
(Fees in 2.1)

3.02 INITIAL REVIEW
Review processes (Exempt, Expedited, Full Board)
Review criteria
Protocol guides
Advertising and Recruitment

3.03 DURING THE LIFE OF THE STUDY
After approval, real life happens...
Modifications, Violations
Harms, risks and problems

3.04 INFORMED CONSENT
--More than you ever wanted to know.
---Divided into bite size chunks.

3.05 IRB SPECIAL TOPICS
Biological specimens
Devices, NSR/SR, HUD

  3.5.1.A. Biol Spec - Points to Consider
  3.5.1.B. Biol Spec -OIG report
  3.5.1.C. Biol Spec Consent form sample 1
  3.5.2.A. Device_Basics
  3.5.2.B. Device_SR/NSR
  3.5.2.C. Device_IRC's_NSR_Policy
  3.5.2.D. Device_SR_Evaluation_Tool
  3.5.3.A. HUD and HDE
  3.5.3.B. HUD_812.100
  3.5.3.C. FDA Guidance
  3.xx another sub

 

 IRC · Independent Review Consulting, Inc. 415.485.0717· Fax 415.485.0328 · info@irb-irc.com