Patient Outcome: Resolved without sequelae Resolved with sequelae Unresolved Death Unknown NOTE: IF THIS STUDY IS INDUSTRY SOPONSORED OR INVESTIGATOR INITIATED, REPORT EVENT TO REGULATORY AUTHORITIES AS PER PROTOCOL AND / OR REGULATORY REQUIREMENTS. SIGN-OFF (not required for within IRISS) Person Completing Form Name: E-mail: Date: Principal Investigator Name (printed): Signature: E-mail: Date: CHAIR/DESIGNATE USE ONLY No further action required Comments/Concerns: Request more information Committee discussion required Signature: Date of Review:
Patient Outcome: Resolved without sequelae Resolved with sequelae Unresolved Death Unknown NOTE: IF THIS STUDY IS INDUSTRY SOPONSORED OR INVESTIGATOR INITIATED, REPORT EVENT TO REGULATORY AUTHORITIES AS PER PROTOCOL AND / OR REGULATORY REQUIREMENTS. SIGN-OFF (not required for within IRISS) Person Completing Form Name: E-mail: Date: Principal Investigator Signature: Name (printed): E-mail: Date: CHAIR/DESIGNATE USE ONLY No further action required Request more information Committee discussion required Comments/Concerns: Signature: Date of Review: