Transferring Patient Data

You can transfer all data (RDCIs, RDCMs, responses, and discrepancies) from one patient record number to another. You might need to do this, for example, when a patient begins as a screening patient and becomes a normal patient. You can transfer all the data at once, or continue entering data based on the original patient number.

When you transfer RDCM patient data between patient record numbers, the RDCMs must be unique. This uniqueness is enforced at the DCM level, as the combination of DCM and qualifying value must be unique at a visit—CPE and subevent—for a patient.

To transfer patient data:

1. Select Conduct then, select Security then, select Patient Transfers. The system displays the Maintain Patient Transfers window.
2. In the Source Patient field, type the ID of the patient whose data is being transferred; you can also use the list of values.
3. In the Target Patient field, type the ID of the patient whose record will receive the data; you can also use the list of values.
4. To continue to enter data under the original patient ID, which will then be transferred to the new record, select the Ongoing Transfer? checkbox. For a one-time transfer, do not select it.

   • A patient may be the target in multiple one-time transfers.

   • An ongoing transfer may have only one source and one target patient.

5. In the Transfer Reason Code field, either type a reason code or use the list of values to select a code from the list. This field is validated against the list of active values in the installation reference codelist RDCI CHANGE REASON TYPE CODE.
6. In the Transfer Reason Comment field, type an explanatory comment, if necessary. This is an optional field.

   Note:

   The Transfer Reason Code and Transfer Reason Comment fields are required to meet 21 CFR 11 auditing requirements.

7. Click the Save button to commit the record.
8. Click the Exit button. The system closes the Maintain Patient Transfers window.
9. From the tree, select Conduct then, select Security then, select Transfer Patients for a Study.

   The "Transfer Patients for a Study" PSUB window opens.

10. Set the value of the parameters. Both parameters accept either "Y" or "N" as values.

    • If you choose to freeze the source patient position, the system prevents further data entry to the Source Patient ID, unless the transfer type is ongoing.

    • If you choose to transfer multivariate discrepancies, the system updates the multivariate discrepancies associated with the Source Patient to reflect the Target Patient information. Otherwise, the system makes these multivariate discrepancies obsolete.

11. Click the Submit Job button.

The system transfers all RDCIs, RDCMs, responses, and univariate discrepancies for all source patients to their respective target patients. The choices in Step 10 are then implemented.

After Oracle Clinical successfully transfers patient data, the Transferred? box is checked and the number of RDCIs transferred is recorded in the Transfer Comment field in the Patient Transfers window. Check the PSUB log file for more information.

After completing the patient transfer job, the system automatically runs the incremental expectedness calculation job for all patients whose data changed. See Planning and Designing a Study in the Oracle Clinical Creating a Study manual for more information.