Protocol Review Committee Amendment Application

Submissions which do not include the correct documentation as described on this form will not be processed or added to an agenda until all required information is provided.

The PRC does not need to review amended consents, investigator brochures or patient supplements.

Principal Investigator First Name

Principal Investigator Last Name

Principal Investigator Email

Is the person submitting this form the PI?

YesNo

Submitter First Name

Submitter Last Name

Submitter Email

Notification Email

Protocol Title

PSCI Number

Amendment Version Date

Summary of Changes

Provide a brief summary limited to key changes only, including rationale.

Upload full protocol showing tracked changes within the document, not as an appendix
(.doc, .docx or .pdf file only)

Upload full protocol with changes incorporated ("clean" version)
(.doc, .docx or .pdf file only)

Upload any notes or emails from the sponsor significant to the amendment
(use "add another file" to add more documentation; .pdf, .doc, .docx or .eml files only)

Comments

Include any helpful information the PI feels would be integral to the review of this amendment by the PRC.

Your submission of this form indicates that the Principal Investigator named herein is aware of all amendments requested and serves in lieu of their signature.