Batch-Deleting Data
Existing CRF data can be soft-deleted via data entry, however you can use a batch job to delete study data when appropriate. For example:
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After loading an Out of Study file, you can delete all data associated with a bad data file or data file group.
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For externally maintained data that is batch data loaded (BDL) and for which the audit history is maintained in an external system.
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Deleting manually entered data from Oracle Clinical, however its use should be limited to data whereby the audit trail is not required to be maintained, for example:
- Data in non-production environments
- Data entered into a study but never made accessible (see Accessibility for more information)
You can navigate to the batch job PSUB window for deleting study data from the Conduct menu, by selecting Security, and then selecting either:
- Delete Study Information
- Delete Study Information with Audit
Note:
Study data deleted using this menu option will be audited.
Specifying the DCI, Document number*, Data file group or Data file is optional. Possible values for these parameters are provided by the <List> function. If no value is specified, all data in the study will be deleted.
*All records associated with the given Document number (inclusive of soft-deleted CRFs) will be deleted.
Note:
Access to Delete Study Information option should be assigned on a least-privilege basis and handled with extreme care. Users with access to the Delete Study Information option have the ability to set the Audit parameter, allowing the user to retain audit upon document deletion ('Y', default setting) or not (N).
Note:
A batch data delete that is not audited (that is, Audit = 'N') is a hard delete - you will have no reference to the deleted CRF data after such a delete. This option should only be considered for scenarios where no audit is required.
If the study is a flex-study, after completing the batch data delete job, the system automatically runs the full expectedness calculation job. See Oracle Clinical Creating a Study for more information.
Note:
For the test mode, from the Definition menu, select Test a Study and then select Delete Study Information. The audit of Study data deleted from this menu option will not be retained (that is, the data will be hard deleted).
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