Sites Site Changes: FAQs
Do I need to report to Quorum any changes regarding sub investigators?
Typically, changes to sub investigators do not need to be reported to Quorum. The only exception is if Quorum requested the departing sub investigator’s CV during study start up.
An element of my 1572 is changing. Do I need to notify Quorum?
You only need to notify Quorum of changes that affect your contact address or information on your consent form.
Will Quorum send me an approval document when I submit a change form indicating that the study coordinator at my site has changed?
Quorum only sends approval documents to sites when the change that has been submitted affects the consent form (such as an address or telephone number change). For all other changes, if the changes are submitted using the OnQ Portal you will receive an acknowledgement that the request was received. Quorum staff will update our records accordingly.
What kinds of changes can I make using the Change Request Form for Sites?
The Change Request Form for Sites may be used to request the following changes:
- Change in Additional Research Facility
- Change in Participant Emergency Numbers
- Change in Site Contact Information
- Change in Compensation of Study Participants
- Request for Translated Consent Form
- Change in Primary Facility Business Name
Download a copy of the Change Request Form for Sites here
What documentation is required for a change in principal investigator?
A change in principal investigator must be reviewed by the Board and cannot be submitted for review until all of the following documents are received:
- A letter from the departing principal investigator explaining why he/she is no longer able to perform the role of principal investigator (if the departing principal investigator is not available to provide a letter Quorum will alternatively accept a written explanation from the new principal investigator).
- “Change in Principal Investigator” form, “Site Information Questionnaire” form or “Observational Registry Site Information Questionnaire” form, if applicable.
- A current (within two years), dated CV for the new principal investigator. Effective January 2008, the PI needs to submit a CV only once. We do not need additional copies of the CV for subsequent site submissions.) For observational registry studies a CV is not required.
- Supplemental material as appropriate based on “Change in Principal Investigator” Form responses (for example, FDA Audit information, letters of explanation, etc.).
Our main facility has moved, can I use the Change Request Form for Sites for a change in Primary Facility?
If your main facility has moved, please submit the Change in Primary Facility Form to Quorum.
