As an alternative to performing manual data entry, you can import Event CRF data from a file using the Captivate web interface. This import feature is useful when your Study data was captured using a system other than Captivate.
The following items are required to import data:
- The Study exists
- Event Definitions for the data being imported exist
- Event CRFs for the data being imported must exist
- Study Subjects for the data being imported exist, unless the study parameters are modified to generate Study Subjects automatically
- Study Subjects must be scheduled for the Study Events for which the data is being imported, unless the study parameters are modified to auto-schedule Events for Study Subjects
The information in the file can be for one or more Subjects, for one or more Events for each Subject, and for one or more CRFs for each Event. The type of information for each Subject does not have to be the same. For example, the file can include two Events, each with a CRF for one Subject, and one Event with three CRFs for another Subject.
The imported Subject CRF data replaces any data that was already captured for that Subject and that CRF, unless a specific change is made to a study parameter that allows skipping existing data. The imported CRF data should contain all data required for the CRF, and should be valid. Automatic checks for imported data are limited and not as robust as when the data is entered manually in the CRF web interface. Errors trigger automatic creation of Failed Validation Discrepancy Notes. If there are no errors, the CRF is automatically marked Complete, unless the study parameters for Auto-Completion are turned off. Any subsequent changes must be done in Administrative Editing mode and require a Discrepancy Note if the CRF was set up that way. If there are any calculated value fields in the CRF, you must either supply the correct data in the import file, or open and save the CRFs manually to generate them.
The data import file must be a properly-formatted XML file.
You can automate the data import process, which is particularly useful when you import data files on a recurring basis.
You can also import data using SOAP Web Services. Refer to the Captivate Programmer’s Guide for details.