Validation and Derivation Procedures

16 Validation and Derivation Procedures

Validation and Derivation Procedures serve two different purposes. Validation Procedures compare multiple Question responses for the same patient for the purpose of ensuring that patient data is valid. Derivation Procedures use calculations to derive values from collected data. However, both types of Procedures are defined the same way, have the same internal structure, and are executed during batch validation.

Procedures operate on data for only one patient at a time. You cannot write a Procedure to compare the data of different patients. When a Procedure is executed during batch validation, the system processes only those patients whose data has changed (including having new data entered) since the last batch validation. The system runs every Procedure over all the data specified in each Procedure for the patient, not just the new or changed data.

Note:

If you want to run a Procedure over all patients, you can run the Procedure manually; see Executing a Single Procedure.

In addition, batch validation automatically runs a Procedure over specified data for all patients if you change the Procedure definition itself.

Batch validation is usually scheduled to run at regular Intervals, such as nightly. During batch validation, all Derivation Procedures are executed before all Validation Procedures, so that you can use the derived values in Validation Procedures. For further information on batch validation, see the Batch Validation section of the chapter "Using the Discrepancy Database" in Oracle Clinical Conducting a Study.

You can create an entirely new Procedure or, if your company has standard DCMs and Procedures, copy one or more to a new study and make any necessary modifications. You can revise a Procedure in an ongoing study and save its current discrepancies by creating a new version of it (see Where to Start). You can test a Procedure before making it active and running it against production data (see Testing a Procedure).

If you want to use the Patient Status feature, you must create a Procedure in each study to populate the Patient Statuses table. Packaged functions with the necessary logic are included with Oracle Clinical. See Maintaining Patient Statuses.

For information about the Oracle Clinical tables and columns you may want to reference in Procedures, see the Oracle Clinical Stable Interface Technical Reference Manual. Contact Oracle Support to receive a copy of this PDF-format manual. There is no charge.

Note:

In order to reference tables that are not already accessible to the Procedure compilation (including basic tables such as RESPONSES and PATIENT_POSITIONS) you must explicitly grant select privileges on the table to the RXC_PD account.

For more information, see:

Parent topic: Defining Data Collection Objects