Data Management and Quality Assurance. Study nurses will fill out a stroke log for all study sites that documents all patients transported by a study ambulance to that site and their discharge diagnosis from the ED. For transported stroke patients who are not enrolled in the trial, the reason for exclusion will be recorded. After the first patient has completed the study at each site, a site visit will be performed by the Study Nurse Monitor. She will review the case report form and compare the data entered to the patient’s medical record. Any inadequacies or errors will be reviewed with the co-investigator at the site. Subsequently, on site case report form monitoring visits will be performed after every 4 patients enrolled at that site. The field-enrolling physician will inform the coordinating center of every patient enrollment on the same or next business day, by faxing an enrollment notification form to the coordinating center. The baseline CT (or MRI) will be copied and transported by the study nurse to the coordinating center within 7 days of enrollment. Computerized data entry from the clinical report forms (CRFs) will be performed by trained data entry personnel at the Data Management Center (Pacific Data Designs). Incoming CRFs will be logged by the Data Management Center. This tracking process maintains a running inventory on pages received so that missing pages may be retrieved to facilitate accurate processing of study data. Data entry will be performed using independent, dual data entry. Data are entered twice with each entry performed by a different person. A third person subsequently compares the two entries, resolves discrepancies, and updates the database as required. Data Management Center data entry operators are trained to enter exactly what is recorded on the CRF. Consequently, all data quality checks are performed after the independent, dual data entry comparisons have been completed. Computerized data quality checks flag discrepant entries for resolution. Every non-text field that is entered into the database has either a range check or internal consistency check, or both, applied to it. Any discrepancies are manually reviewed. Discrepancies will be queried and sent to the head study coordinator at the Clinical Coordinating Center for resolution. Entered data are automatically forwarded to the Data Management Center’s Clinical Data System for storage and processing. Clinical Data System is a completely validated Clinical Data Management System that runs under Windows N...
