Source Worksheets

CONFORM L1 - Concomitant Medication

CONFORM L2 - Protocol Deviations

CONFORM P01 - Procedure Source Worksheet

CONFORM P02 - CLASS Implant

CONFORM P03 - CLASS Delivery System

CONFORM P04 - CLAAS Device Deficiency Worksheet

CONFORM P05 - Control Implant

CONFORM P06 - Echo Exclusion Criteria

CONFORM P07 - Additional Procedure Source Worksheet

CONFORM P08 - Patient Population

CONFORM P09 - Procedure Lab Assessments

CONFORM Pivotal Trial TEE TTE Sonographer Worksheet

CONFORM SW - Visit Information

CONFORM SW01 - Screening Data Worksheet

CONFORM SW01a - Shared Decision Making Source

CONFORM SW02 - Inclusion-Exclusion Criteria

CONFORM SW03 - Medical History

CONFORM SW04 - Vital Signs

CONFORM SW05 - Physical Examination - Review of Systems

CONFORM SW07 - CHADS2VASc

CONFORM SW08 - HAS-BLED

CONFORM SW09 - ECG

CONFORM SW10A - Echocardiography-CT Screening

CONFORM SW10B - Echocardiography-CT Procedure

CONFORM SW10C - LAA Measurements

CONFORM SW11A - Echo-CT Pre Discharge

CONFORM SW11B - Echo-CT Follow Up

CONFORM SW12 - Screening Lab Assessments

CONFORM SW13 - NIHSS

CONFORM SW14 - QVSFS

CONFORM SW15 - mRS

CONFORM SW16 - Adverse Event Source Worksheet

CONFORM SW16A Adverse Event Source

CONFORM SW18 - Neurological Event

CONFORM SW19 - Systemic Embolization

CONFORM SW20 - Death

CONFORM SW21 - Chemistry - Cardiac Enzymes

CONFORM SW22 - Study Exit

CONFORM SW23 - Pericardial Effusion Source Worksheet

F-041 Rev G Delegation of Authority Log Template