Checklists

(required as the first page of all submissions to the IRB)
Activity Determination Form :: July 2009
Request for Exemption :: June 2008
New Protocol (N) :: June 2009
New Protocol Chart Review or Disc Tissue (N-C or /DT) :: May 2007
Continuing Review (CR) :: May 2007
Continuing Review Chart Review or Disc Tissue (CR-C or DT) :: August 2005
Emergency Use of Drug or Device (EMRG) :: May 2007
Protocol Addendum (A) :: August 2005
Information to File with Protocol (F) :: August 2005
Report Unanticipated Problem or Protocol Deviation (UD) :: July 2007
Report External Adverse Events (EAE) :: July 2007
Report Internal Adverse Events (IAE) :: July 2007
Closure of an IRB Approved Protocol (C) :: May 2007 (Note: replaces Protocol Termination (T) )

Forms

(completed to provide additional information as part of a submission to the IRB)
Request for Expedited Review of New Protocol :: October 2002
Additional Required Information for a Study that Includes Prisoners :: August 2004
External AE Summary Log :: July 2005
Internal AE Summary Log :: July 2005
UH Administrative Form, CP-7: IDS Exception Request Form (Word version) :: May 2009

Templates for Consent Documents

(contain required and suggested language to use in developing consent forms)
Assent Language :: March 2008
Consent Language for International Studies :: April 2007
Consent Template :: August 2009
Consent Language and Tutorial :: October 2007

Reminder Lists

(lists to help users determine if IRB submissions are complete)
New Protocol :: August 2009
Continuing Review :: August 2005
Addendum :: August 2005
Chart Review/Discarded Tissue Reminders

Adverse Event Reporting Forms and Information