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  1. What documentation is required for a change in principal investigator?

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    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 Request Form for Sites”, “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 Request Form for Sites” responses (for example, FDA Audit information, letters of explanation, etc.).
  2. What kinds of changes can I make using the Change Request Form for Sites?

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    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
    • Change in Principal Investigator

    Download a copy of the Change Request Form for Sites here

  3. Will Quorum send me an approval document when I submit a change form indicating that the study coordinator at my site has changed?

    Comments Off on 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.