Ongoing Review

​Revised Investigator or Site Location Information

If there is a change in investigator (PI/QI or Sub-I) or site location information, you must submit a Revised Investigator or Site Location Information Submission Form. If the revision is due to change in PI/QI or the addition of a Sub-Investigator, you must also submit a completed Revised Investigator or Site Location Information Submission Supplement Form.

For change in PI/QI only, you must also submit:

  • New PI/QI's Curriculum Vitae (CV) 

  • Statement from the Sponsor approving the change of PI/QI

  • New PI's current medical license (Mississippi and Puerto Rico only) 

Forms and corresponding documentation can be submitted to Schulman via:

Schulman will acknowledge receipt of a Revised Investigator or Site Information Submission via e-mail.

If the changes require modification to the most recent Schulman approved Informed Consent (IC) (e.g., phone number change, change of address or change of PI/QI), the site and designated contact person from the Sponsor or CRO will receive a revised IC and corresponding approval letter.