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.