INSPIR II Instructions for Investigators
For available IRB Word/PDF templates, please visit the IRB Templates page at https://www.bumc.bu.edu/irb/inspir-ii/irb-templates/
How To
General
- How to get access to INSPIR II
- How to log-in to INSPIR II
- How to update your Personal Profile (required for everyone listed on a study)
- How to update the department in your Personal Profile
- How to get the Study Assistant tab if you don’t have it
- How to sign off on protocol as PI
- How to set up a Proxy for Principal Investigator
- How to sign off on protocol by Department Chairs
- How to set up a Proxy for Department Chair sign-off
- How to check the status of a submission
- How to retract a submission
- How to add/remove an Administrative Assistant or a Study Contact in an approved protocol (Section 3)
- How to add/remove internal investigators/research staff in an approved protocol (Section 3)
- How to create Personnel Pools in INSPIR
- How to add BU CRC Students, Faculty, or Employees to your study
- How to conduct research with Community Health Centers (CHCs)
- How to look up user training information in INSPIR
- How to upload training certificates to your INSPIR II Profile
- How to print out previously uploaded training certificates from INSPIR II
- How to Access your own CITI Completion Certificates and Reports on the CITI website
- How to send a study correspondence in INSPIR II
- How to view or print out the Approval Letter in INSPIR II
- How to Hide an Inactive Study or Display a Study that was Hidden by Mistake
- How to Locate Study Specific Consent forms and Study Documents in INSPIR II
- How to upload password protected PDF documents in INSPIR
- How to forward your BU emails to your favorite email address
New Study – Initial Reviews
- How to create a new protocol draft in INSPIR II
- How to find and open a draft in INSPIR II
- How to add a new Consent Form
- How to add a new Study Document
- How to setup Department Chair and Special Routing Sign Off
- How to sign off on protocol as PI
- How to sign off on protocol by Department Chairs
- How to respond to a Review Response for an Initial Review
- How to revise an existing Consent Form
- How to revise an existing Study Document
Amendments
- How to create and submit an Amendment
- How to revise an existing Consent Form
- How to add a new Consent Form
- How to revise an existing Study Document
- How to add a new Study Document
- How to sign off on the Amendment as PI
- How to respond to a Review Response for an Amendment
- How to add new internal investigators/research staff to an approved protocol
Continuing Review/Progress Report
- How to create and submit a Continuing Review
- How to sign off on the Continuing Review as PI
- How to respond to a Review Response for a Continuing Review
Closing a Study
- How To Close an Exempt Study (To close a study with one of these statuses: Exempt, Exempt – no IRB review, Exempt – limited IRB review, NHSR, and Not Engaged)
- How to create and submit a Final/Closure Report (Used to close non-exempt studies and ceded-review studies)
Other Submission Forms
- 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)
- How to Create and Submit a Protocol Exception Form
- How to Create and Submit a Recruitment Materials Submission Form (Used only to submit promotional recruitment materials that have been approved by the Communications office)
- How to Create and Submit a Contact Information Change Request Form (Used only to request changes to the contact information in approved consent forms and/or other subject material)
Forms that are no longer in use
- 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.)