Submitting a Protocol for External Review with Yale HRPP IRES – Requesting Single IRB
External Review, or Single IRB, use can only be granted by Yale HRPP/IRB. All protocols must go through Yale HRPP/IRB in order to request use of an external IRB. There is a separate, expedited submission pathway along with unique documents. Please note the Yale HRPP/IRB specific documents below. Complete the forms and follow the procedures outlined below.
Documents you'll need
- ☐ Yale HRPP specific documents
- — Financial disclosure
- Put PI’s name in upper right corner along with Yale IRB#
- — Request to use External IRB
- Select chosen by sponsor on document (question 2) should it be true.
- ☐ Study Protocol
- — You can use sponsor protocol for industry sponsored projects
- ☐ Informed Consent Forms (ICFs)
- — Use track changes for consent form modifications
- ☐ Recruitment
- — Centralize all recruitment materials into one folder for IRES upload
- ☐ Patient Facing Materials
- — Centralize all recruitment materials into one folder for IRES upload
- ☐ Sponsor Contract
-
Create an initial submission in IRES
- ☐ Basic Study Information Section
- — Completed question 5 for external IRB (yes)
- — Leave question 6 blank for Lead Principal Investigator
- — Load only the most recent protocol to last question
- ☐ External IRB Page
- — Question 3: write "non-responsive"
- ☐ Drugs
- — Load the Investigator Brochures to question 3 “attach files”
- ☐ Local Site Documents
- — Consent forms
- Include only ICFs with track changes
- — "Other Attachments"
- Load:
- Request to use external IRB doc
- - Financial disclosure
- - Sponsor contract
Maintenance:
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☐ Submit annual approval Continuing Review letter from central IRB to IRES for record keeping.