Key Findings

A comprehensive data analysis of the full iRIS new submission data set (Feb 2010-July 2013) showed:

  •    More than 80% of new submissions are returned at least once for pre-review corrections
  •    Most studies undergo several submission and review rounds prior to approval
  •    Close to 50% of the total T2A is time spent waiting for the study team to respond to requests for corrections or changes


The project team identified several factors contributing to lengthy turnaround times:


  • Many submissions are sent in incomplete and/or with improperly formatted consent forms
  • Studies submitted to CHR without required feasibility and scientific merit review add to the overall T2A
  • Poorly-prepared applications take excessive time and resources to screen and review
  • Multiple rounds require the analyst to review the same submission several times

Application Issues

  • The current Study Application is ill-suited for social and behavioral research and other non-clinical research study submissions, causing confusion and incomplete or incorrectly prepared submissions
  • Some sections of the application in clinical research submissions are frequently completed incorrectly, indicating users may not fully understand what information is being requested

60-day response window contributes to delays

  • CHR Coordinators often have to screen more studies than they need to try to get back enough studies to fill agenda slots
  • Agenda spots go unfilled if corrections aren’t submitted in time
  • Over-screening delays preparation of correspondence from committee reviews after the CHR meetings