Home › Sponsors/CROs › Study Changes
Sponsors and investigators are responsible for obtaining prospective Board review for changes in research activity. Examples of changes in research that should be submitted to the Board for review and approval include:
- Amendments and changes to the protocol (including administrative changes such as protocol clarification letters)
- Change in principal investigator
- Changes in the primary and/or additional research facilities (location move, suite number change, facility name change, etc.)
- Addition of research facilities for a previously approved investigator
- Changes in the investigator’s conflict of interest status
- Notification of study completion/closure
- Planned increase in the number of participants to be enrolled in the study
- Changes in planned enrollment of vulnerable populations, including, but not limited to, employees and family members of employees, illiterates, and non-English speaking participants
- Intentional departure from the inclusion/exclusion criteria set forth in the protocol when such variation affects the safety or welfare of study participants or affects the study integrity, even if the departure is approved by the sponsor
U.S. amendments can be submitted to one of the daily meetings and must be submitted by 5:00 p.m. PT 36 hours prior. Canadian research must be submitted (with all required elements) to the Wednesday meeting by 5:00 p.m. PT the prior Wednesday.
Recommended
F-011 - Amendment Submission Cover Page
This Cover Page prompts the Sponsor to inform Quorum if there are any unique circumstances surrounding the Amendment, including sub-sets, compensation revisions, and reconsenting plans. It is not a required form but ensures that an Amendment is correctly and completely processed by Quorum.
F-012 - Central Study Information Change Request Form
This form used to communicate with Quorum Review regarding MAJOR changes to central study information, including changes in study contact, billing contact, shipping preference, and submission and acknowledgment preference.
Guidance
G-024 - Amendment Submission Checklist
This Checklist contains the items that may be needed when submitting an Amendment to Quorum. This is not a required form, but may be helpful to ensure that an Amendment submission is complete.
G-043 - Handbook for Quorum Review IRB (Requires an OnQ Portal Account)
The Handbook provides a guide for using Quorum Review IRB as an ethics review board. It contains policies, procedures, and guidelines to be used in preparing materials for Board review, as well as information on managing ongoing research activities, continuing and periodic review, and closing.
Q. When should I submit a protocol amendment? >>
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.
Q. What do I need to include if I want to submit an amendment? >>
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.
Q. How do I submit an amendment? >>
Amendments may be submitted via the OnQ Portal, over email to your Study Manager, or through the mail.
Q. How often are amendments reviewed? >>
Amendments are reviewed at our Daily Board meeting.
Q. Do I need to submit administrative changes? >>
Yes. Any modifications to the Protocol should be submitted to Quorum for review prior to implementation.
Q. How do I notify you if a contact within our company changes? >>
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.
Q. 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.
Q. 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.
Q. What happens when there are changes to study tools? >>
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.
Q. How do I request a consent form revision? >>
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.
Q. How do I locate the most current version of the “Quorum-approved” consent form? >>
A Microsoft Word version of the most current "Quorum-approved" model consent form can be found on the OnQ Portal.
