Sponsors/CROs Study Changes: FAQs
All proposed changes to an approved protocol or consent form(s) must be submitted by the sponsor to the Board prior to implementation. Once the Board has reviewed and approved the change to the protocol and any corresponding consent form revisions, Quorum will issue a Sponsor Letter of Amended Approval to the sponsor and Amended Approval documents to all approved/active sites in the study.
When submitting an amendment to Quorum you must include:
- Amendment Submission Coverpage
- Protocol Amendment
- Summary of changes per the Amendment (including rationale)
- Revised consent form(s), if applicable. Modifications must be incorporated into the current IRB approved consent form, using the ‘Tracking’ feature in Microsoft Word.
Amendments may be submitted via the OnQ Portal, over email to your Study Manager, or through the mail.
Amendments are reviewed at our Daily Board meeting.
Yes. Any modifications to the Protocol should be submitted to Quorum for review prior to implementation.
Please complete and return the Central Study Change Form. You may use this form to indicate primary and secondary contact changes, billing contact changes, changes in shipping preference, and acknowledgment and shipping preference changes.
We are adding a sub-study that only some sites will participate in; how should we submit this information?
You may submit this sub-study using the amendment submission process described above. On the Amendment Submission Coverpage, please indicate that only a subset of sites are participating in the sub-study and provide a list of sites and rationale.
We’re revising our protocol, but first we’d like to know what the Board thinks. How do we go about getting this input?
If you’d like to get feedback on a protocol revision, a Chairperson Study Assessment can be arranged. Chairperson Study Assessments are typically a conference call arranged between the sponsor/CRO and Quorum. Chairperson Study Assessment teleconferences consist of, on Quorum’s side, the Board chair, Regulatory, Initial Study Support and Study Management.
Since protocol study tools are considered participant study materials, Quorum Review processes them as we would new or revised participant study material and a Quorum Review-approved stamped copy of the approved participant study material is sent to sites.
Revised protocol study tools should be submitted to Quorum Review for approval prior to being distributed to participants.
Revisions to consent forms must be submitted by tracking all requested changes electronically into the current Board-approved version of the consent form. Consent form revisions independent of a protocol amendment must include written rationale for each change made.
Some revised consent forms may qualify for Expedited Review. Please contact your Study Manager for more information.
A Microsoft Word version of the most current “Quorum-approved” model consent form can be found on the OnQ Portal.