About Freezing and Locking Data

After response data has been reviewed and cleaned, you may want to ensure that no one makes changes to it unless explicitly authorized. You may also want to prevent any new data from being entered for a particular study or study site, or by a particular Investigator.

Oracle Clinical includes two related mechanisms for data security: Freezing and Locking. These mechanisms are described below and contrasted in Table 9-1.

About Locking Data

Locking prevents changes to previously collected data, with the following exceptions:

• Users with Privileged Update access can update locked RDCM or RDCI data. Derived Questions within a Locked RDCI or RDCM may still be updated by running Batch Validation (see Using Batch Validation for further details).

You can lock data collected in a particular RDCM or RDCI, or lock all data for which a particular Investigator is responsible in a single study, or all data in a study site, or all data for a range of patients or individual patient, or for a single event, DCI, or data accessibility date range. For more information, see Locking Data.

After data has been locked, it cannot be unlocked. However, users with Privileged Update can modify locked data in Update or any other mode.

About Freezing Data

Freezing data prevents any further data from being entered for the unit frozen, and also locks data already collected for the unit. You can freeze data by the following units: study, Investigator (all study sites currently assigned to a single Investigator), study site, patient range, or individual patient. When you freeze a study, the system also freezes sites and patients for the study. The study-level lock excludes the study from any validation processing. See Freezing Data.

Frozen units can be unfrozen by users with the necessary privileges, and new data entered (see Unfreezing Studies, Study Sites, Investigators, and Patients). However, collected data locked as a result of freezing remains locked and can be modified only by users with privileged update.

Table 9-1 Comparison of Freezing and Locking Data

Characteristic	Freezing	Locking
Unit affected	Can freeze study, study site, all study sites currently assigned to one Investigator, patient range or individual patients.	Can lock one or more RDCMs or RDCIs; can lock by Investigator, study site, patient range, individual patients, event range or single event, DCI name, or Data Accessibility Start and End Date.
Cascade effect?	Yes, subunits are frozen and patient data within frozen units is locked.	No.
Possible to undo?	Can unfreeze.	Cannot unlock.
Data modifiable?	No, but can unfreeze and then modify locked data via privileged update.	Yes, by users with privileged update.
Effect on future data collection	Prevents future data collection for the unit frozen.	No effect on future data collection.

You can freeze and lock data by submitting standard PSUB batch jobs. You can also lock individual RDCIs and RDCMs manually.