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INSPIR II Instructions for Investigators

For available IRB Word/PDF templates, please visit the IRB Templates page at http://www.bumc.bu.edu/irb/inspir-ii/irb-templates/

How To

General

New Study – Initial Reviews

Amendments

Continuing Review/Progress Report

Other Submission Forms

  • How to create and submit a Final/Closure Report
  • How to create and submit a Reportable Events and New Information Form (Used for submitting Unanticipated Problems, Major Protocol Deviations, and DSMB, DMC, or other safety monitor’s report WITH recommended changes to the study)
  • UPSER/AEs form (No longer in use – Please submit a “Reportable Events and New Information Form” instead)
  • Deviation Report form (No longer in use – To report major deviations, please submit a “Reportable Events and New Information Form”; To report minor deviations, please include a description of these minor deviations or attach a minor deviation log at the time of continuing review.)

Other Software Manuals and Resources