Data Collection
The purpose of the registry is to collect uniform and meaningful data on patients requiring Ig therapy. Since, at the time of enrollment, patients will be at various stages in their disease course and medical care, the registry is focused on collecting all assessments and clinical outcomes associated with the management of their disease. Thus, to promote data uniformity among all registry subjects, both retrospective and prospective data collection may be required.
Upstream and Downstream Data Capture
The registry will allow for the complete capture of the patient's medical record from the treating physician and amalgamate it with the treatment activity and capture from Coram's interventions. Thus, providing an accurate portrait of the Ig patient and allowing for a better understanding of the treatment continuum.
IDEaL Patient Registry bridges the gap between upstream and downstream clinical data in order to provide a more complete picture of the treatment space.
Quality Assurance of Data
Data collected through this registry will be entered into a validated database designed by CCT in collaboration with a third-party electronic data capture and reporting vendor. CCT staff will review the data for missing points, incomplete information, and discrepancies with previously submitted data. If necessary, issues are resolved with the site electronically, by telephone, fax, or site visit. All data management and analysis will occur in a validated computing environment.
Statistical Methods and Data Reporting
Data will be analyzed and reported periodically upon individual request from participating physicians. In addition, reports may be provided to appropriate regulatory authorities. Analyses will be performed using the SAS® statistical software system. Baseline demographic and background variables will be summarized for the subjects enrolled in the registry using descriptive statistics. For categorical variables, frequencies and percentages will be presented. For continuous variables, descriptive statistics (n, mean, median, standard deviation, minimum, andmaximum) will be presented.
