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This paper describes the data management processes and systems that were developed by the data coordinating center of the Asthma Clinical Research Network.
All case report forms were also reviewed by the data coordinating center (DCC) for completeness.
Thus, no identifying personal information is sent from the participating sites or received by the data coordinating center or the repository.
Packing was done by a central facility under contract to CHX Technologies Inc., and active and control boxes were prepared in separate production runs using label identifications (IDs) supplied by the data coordinating center.
CHX Technologies Inc. provided the study treatments and some funding for: the microbiology ancillary study carried out at the Tufts clinical center, economic analyses conducted by the data coordinating center, and the calibration of dental examiners and recorders.
A clinical event committee (CEC) has been formed to review and adjudicate reports prepared by the data coordinating group to detect any possible safety issue and/or related deficiencies in data collection if required.
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Inconsistencies or clarifications were handled by a dialogue between the data coordinating center and the individual studies.
Relevant data were collected from source documents and prospectively entered into a computerized database by specialized personnel of the data coordinating Intracoronary Stenting and Antithrombotic Research (ISAR) center.
Participants who miss an assessment or an appointment are reminded by the Clinical Research Assistant from the data coordinating center concerning their participation in the study or questioned regarding their reasons for absence.
The data coordinate system is defined by axes ax1 and ay1.
Subjects will be enrolled at seven clinical centers across the United States and data will be analyzed by the central data coordinating center.
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