Oracle Clinical Blinding Security

Security access to the real treatment codes within Oracle Clinical is controlled by the Randomization Access Status Code (RAND_ACC_STAT_TYPE_CODE). The Oracle Clinical Randomization Adapter checks the value of this code in Oracle Clinical. The value in Oracle Clinical determines whether the real data can be loaded or only the dummy data, and determines the value set for the Blinding Status of the target Table instance:

  • If the value is either Open or Release, the Load Set can load the real codes. The system sets the Blinding Status of the target Table instance to Unblinded.

  • If the value is Access, and the RXA_ACCESS.TREAT_ACCESS_STUDY view exists in the user account being used to connect to Oracle Clinical, then the Load Set can load the real codes. The system sets the Blinding Status of the target Table instance to Blinded.

  • If the user is trying to download the real codes and the RAND_ACC_STAT_TYPE_CODE value is anything other than Open, Release, or Access, the system raises an error and the load fails.