Understanding Oracle Clinical

Study Maintenance

Once a study goes live and all the derivations and procedures are active, the pressure may be off, but some programming work will continue. Batch loading data that comes in from central labs or other places, coding updates, and mass changes are frequently requested along with changes to the CRF and edit specifications. For information on making changes to the CRF and edits, please refer to the previous sections.

Mass Changes

A major change to collected data may be required because of a typo in the original DCM or CRF that is stored in a defaulted field. Perhaps the most common instance of this is when drug names are defaulted into a repeating question group, and the misspelling is not noticed until coding is activated. Should such a situation occur, you have two good options for fixing it: doing a mass change or batch loading data to replace the current data. Regardless of which method you choose, you will also have to ensure that new data is not entered incorrectly by updating the defaulted term in the DCM.

If your SOPS allow them, mass changes can be set up much more quickly than batch-loaded data; however, they may take longer to execute. Depending on your version of OC, you may have to create multiple candidate groups and repeat the same mass change on each one. On the other hand, batch loading correct data into OC to update the previous data will probably execute more quickly but may require much more time to create and verify the source file, especially if new ...