Internal Review

Submitting a Protocol for Internal Review
with Yale HRPP IRES

Documents you'll need

1. ☐ Yale HRPP specific documents
   1. — Financial disclosure
      1. Put PI’s name in upper right corner along with Yale IRB#
2. ☐ Study protocol
   1. — Be sure to complete the appropriate protocol document
      1. Contact [email protected] if you are unsure which document to use
3. ☐ Informed consent forms (ICFs)
   1. — Use track changes for consent form modifications
   2. — Put the Yale IRB # on the first page as part of the title
      1. Contact [email protected] if you are unsure which document to use
4. ☐ Recruitment
   1. — Write Yale IRB# in upper right or left corner for each document.
5. ☐ Patient facing materials
   1. — Write Yale IRB# in upper right or left corner for each document
6. ☐ Research materials (surveys, instruments, instructions, etc.)
7. ☐ Sponsor contract (if applicable)
   1. — The study contraHTMLct should only include language related to the study protocol, and patient engagement. All financial documents, ancillary materials are for a different office – not the HRPP/IRB

Create an initial submission in IRES

1. ☐ Basic Study Information Section
   1. — Completed question 5 for external IRB (no)
   2. — Load your Principal Investigator
      1. If PI name is not in list, then they do not have a Net ID. Will need to go get one.
   3. — Load only the protocol document into last question 
2. ☐  Drugs/Devices
   1. — Load the Investigator Brochures (if applicable) to question 3 “attach files”
3. ☐  Local Site Documents
   1. — Consent forms
      1. Include only ICFs with track changes
   2. — Recruitment
      1. Be sure to include only recruitment materials here – no patient-facing study materials
   3. — Other Attachments
      1. Load each and label with their titles:
         - Financial disclosure
      2. - Sponsor contract
      3. - Patient-facing study materials
      4. - Research materials

Maintenance

1. ☐ Submit annual Continuing Review letters into IRES
2. ☐ Submit modifications as needed into IRES.