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 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.).