Site Changes
Any change in approved study site information must receive review by Quorum and approval prior to implementation. The one exception is new contact information that does not require changes to the consent form. Quorum requests that all documentation be received at least two weeks prior to instituting the change(s) to allow for administrative processing time and Board review as necessary.
Please see the forms tab (above) for the different types of change forms your site may need to submit to Quorum and the required documentation for each.
Required
F-028 - Change in Primary Facility Form
Prior to any primary facility change of address, please submit: A Change in Primary Facility Form or a Change Request Form for Sites and a revised Site Information Questionnaire *Please note that the Site Information Questionnaire is recommended if you are changing multiple items (e.g. Facility and Principal Investigator)
F-029 - Change in Principal Investigator Form
This form should be completed when the Principal Investigator at a site has changed. Change in Principal Investigator submission includes this form, the new Principal Investigator's CV, a letter from the Departing Principal Investigator indicating why a Change in PI is requested and any additional facility forms signed by the new PI.
F-037 - Change Request Form for Sites
Sites may use this form to communicate changes in site information to Quorum throughout the course of the study. Changes that may be reported on this form include changes in Additional research facility, site contact information, participant emergency numbers, compensation, business name, and requests for translated consent forms.
Supplemental
F-038 - Additional Facility Site Information Questionnaire
This form is required for all addresses beyond the primary facility research facility where research is conducted and more than minimally invasive procedures are performed.
F-039 - Site Information Questionnaire
This form is a required element of an investigator's initial site submission to Quorum Review. This form is also required when the Principal Investigator of a site changes.
Guidance
G-038 - Changes to Site Information - Guidelines
This guidance sheet contains a list of the types of changes that may be submitted to Quorum, as well as lists of any forms and supporting documents required for each type of change.
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.
- 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
- 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 signed by the new principal investigator for the primary facility
- 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.)
- Supplemental material as appropriate based on "Change in Principal Investigator" Form responses (for example, FDA Audit information, letters of explanation, etc.).