How do I submit a protocol amendment?

Quorum requires review of all changes in research activity, including protocol amendments and/or consent form revisions. Quorum offers a cover sheet to assist with submitting an amendment.

Please submit the following required information, at minimum, to your Study Manager:

  • Cover letter
  • Summary of changes
  • Rationale for changes
  • Full text of amendment or amended protocol
  • Tracked, electronic copy of consent form(s), (if applicable)

All consent form revisions must be tracked in electronically using the current, Board-approved version of the consent form. Some protocol amendments may qualify for Expedited Review. Please contact your Study Manager for more information.