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  1. General tips:
    1. The Tufts MC research coordinator can create the modified ICF or the CCHMC can revise the ICF template to include the Tufts MC template language
    2. The CCHMC CEGIR lead site coordinator will be the main contact for the Tufts PI and study coordinator.
  2. Submit the following to the Tufts Health Sciences IRB (for each CEGIR study):
    1. Protocol
    2. ICF with Tufts template language added (the Tufts MC research coordinator can create the modified ICF or the CCHMC can revise the ICF template to include the Tufts MC template language)
    3. Form 9:
      1. Mandatory Human Subjects Protection Education (CITI)
      2. Pharmacy
      3. Radiation Safety
      4. Biosafety
    4. Research financial COI
    5. Site-Specific Appendix (Include the following as appendices to the Site-Specific Appendix)
      1. CCHMC SAE /UP Policy (refer to these in section O)
      2. PI Responsibilities (refer to these in section P)
    6. Protocol Specific Application to Rely
    7. Site Information Sheet (this is for protocol specific site information)
    8. Staff Log
    9. If Tufts Medical Center is the recipient of a grant for any CEGIR study, please submit the grant. If Tufts is the grant recipient, we would make a determination about whether the proposed research is within the scope of the grant
  3. Submit the following to the CCHMC IRB (for each CEGIR study):
    1. Protocol Specific Application to Rely (after it has been reviewed by the Tufts Health Sciences IRB Office)
    2. Staff Log – Please ensure that their staff logs remain current with the CCHMC IRB.
    3. ICFs (You can ask CCHMC IRB to revise the ICF to include the Tufts template language) The Tufts version of the ICF then needs to be submitted to the Tufts Health Sciences IRB for review.
    4. The Reliance determination form. This form is simply a confirmation that the local IRB is aware of the specific protocol and continues to be okay with a reliance on the CCHMC IRB.
  4. Site Activation:
    1. The CCHMC IRB will activate an amendment to add the Tufts MC site, and they will send the Tufts PI and study coordinator an e-mail containing the protocol documents, including a consent template, questionnaires, etc.

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