CORE LABORATORY SERVICES. 2.1. STUDY PREPARATION, SITE SET-UP AND STANDARDIZATION
CORE LABORATORY SERVICES. Incoming 12 lead ECGs will be evaluated for demographic consistency and recording quality. ECG tracings will be manually evaluated by board certified Cardiologists/Electrophysiologist. ECG tracings will be read and interpreted with the comprehensive evaluation of rhythm, conduction intervals, and morphology. ECGs will be evaluated at pre-procedure, hospital discharge, and events.
CORE LABORATORY SERVICES. Table 1.1.1. General Study Assumptions # of Patients 330 Patients # of Sites 60 Sites: Located in Russia, Ukraine, Poland, UK, Bulgaria, Australia # of Investigator’s Meetings including location, # of BIOCLINICA representatives attending meeting and # of days assumed for meeting, including travel time One (1) Meeting: Location to be determined One (1) Representative Two (2) Days Type of imaging Performed Contrast-Enhanced CT of the Chest, Abdomen and Pelvis CT Data Assumptions Total # of Patients with CT 100% or 330 Patients Average # of Timepoints per patient 7 Timepoints: Baseline, 6 Weeks, 12 Weeks, 18 Weeks, 24 Weeks, 30 Weeks, 42 Weeks, 54 Weeks, 66 Weeks and 78 Weeks Total # of CT Timepoints 2,310 Timepoints Average # of Files / Anatomical Regions scanned per timepoint 3 Files: Chest, Abdomen and Pelvis Quantification and Independent Read Plan Assumptions Measurement Criteria Uni-dimensional RECIST Independent Read Plan Efficacy and Adjudication Review Independent Read Assumptions Efficacy Read # of Timepoints Prepared for Review 4,620 Timepoints: 2,310 Timepoints per Reader # of Independent Reader(s) Two (2) Independent Readers Adjudication Read % of Timepoints to be Adjudicated 15% or 347 Timepoints # of Adjudication Readers One (1) Adjudicator Read Data Summary Overall Total # of Timepoints Prepared for Review 4,967 Timepoints # of Data Transfers and Frequency, including a test transfer 4 Transfers: Timing to be determined 1 Test Transfer: Timing to be determined Disease Progression Notification Assumptions # of Notifications Fax Notification of Disease Progression to ALCHEMIA and the site (assuming 290 notifications) BIOCLINICA has assumed that all image data for a given timepoint will be sent to BIOCLINICA from the sites as the given timepoints are completed. BIOCLINICA will provide directions to the study sites regarding proper shipment of the image data to BIOCLINICA, and will coordinate the transmittal of the data from the site to BIOCLINICA. Alchemia Oncology Pty Ltd Protocol ACO-002 An audit trail will be consistently maintained for each step of the BIOCLINICA process in compliance with the applicable regulatory requirements including Good Clinical Practice (GCP) and FDA 21 CFR part 11. If available, ALCHEMIA will provide BIOCLINICA with the final study protocol, subsequent amendments and study case report forms at the start of the study. All original image data sent to BIOCLINICA will be returned to ALCHEMIA upon completion of the project ...
