Create a data access policy

Specify a study or patient group and a set of personally identifiable information (PII) that should be visible to certain users. All users assigned to the data access policy have access to the specified PII data for the subjects or patients in the specified study or patient group. If some users should have access to a different set of PII data for the same study or patient group, create a different data access policy for them.

Note:

The same steps apply when creating a data access policy for the Omics Data Bank.

To create a data access policy:

  1. On the database server, log in to SQL*Plus as CDM.
  2. Run VPD_UTIL.ADD_VPD_CONFIG, entering values as follows:
    • A unique name for the data access policy.
    • The name of one study or patient group whose data will be accessible through the data access policy.
    • A description of the data access policy.
    • A value for every attribute group parameter containing either subj or pt, depending on whether you specified a study or a patient group.

      A value of Y allows access. N prevents access. For a description of each attribute group, see:

      Table 2-1

      Table 2-2

      Table 2-3

    • Optional! An expiration date for the data access policy in the format YYYY-MM-DD. On this date the data access policy will be automatically deactivated and any users assigned to it will no longer be able to access subject/patient data through it.

      Note:

      For data access policies for Omics Data Bank, the date applies only when I_PT_ODB or I_SUBJ_ODB are set to N (No). This means that the data access policy restricts access to omics data for users. In these cases, the date represents the last day of the restriction.

Example 1 - Data access policy with some PII access to 'Study B' subjects

BEGIN
VPD_UTIL.ADD_VPD_CONFIG    (I_CONFIG_NAME  =>	'STUDY_B_SUBJECTS_FULL_PII' ,
I_SUBJ_ADD     =>	'N'                                    ,
	I_SUBJ_CONSENT =>	'Y'                                    ,
	I_SUBJ_DATE    =>	'Y'                                    ,
	I_SUBJ_DX      =>	'Y'                                    ,
	I_SUBJ_ENC     =>	'Y'                                    ,
	I_SUBJ_HIST    =>	'Y'                                    ,
	I_SUBJ_ID      =>	'Y'                                    ,
	I_SUBJ_MED     =>	'Y'                                    ,
	I_SUBJ_NAME    =>	'N'                                    ,
	I_SUBJ_OBSV    =>	'Y'                                    ,
	I_SUBJ_PROC    =>	'Y'                                    ,
	I_SUBJ_SPEC	   =>	'Y'                                    ,
I_DESCRIPTION  =>	'data access policy with access to all Study B subjects with all PII attributes except subject name and address',
I_SUBJECT_STUDY=>'Study B'
	);
END;
/

Example 2 - Data access policy with full PII access to GROUP1 patients

BEGIN
VPD_UTIL.ADD_VPD_CONFIG    (I_CONFIG_NAME  =>	'GROUP1_PATIENTS_ALL_PII' ,
	I_PT_ADD     =>	'Y'                                    ,
	I_PT_CONSENT =>	'Y'                                    ,
	I_PT_DATE    =>	'Y'                                    ,
	I_PT_DX      =>	'Y'                                    ,
	I_PT_ENC     =>	'Y'                                    ,
	I_PT_HIST    =>	'Y'                                    ,
	I_PT_ID      =>	'Y'                                    ,
	I_PT_MED     =>	'Y'                                    ,
	I_PT_NAME    =>	'Y'                                    ,
	I_PT_OBSV    =>	'Y'                                    ,
	I_PT_PROC    =>	'Y'                                    ,
	I_PT_SPEC	 =>	'Y'                                    ,
I_DESCRIPTION  =>	'data access policy with access to GROUP1 patients for all PII attributes',
	I_PATIENT_GROUP  =>'GROUP1',
I_EXPIRATION_DATE       => date '2025-12-31'
	);
END;
/

Example 3 - Data access policy with full PII access to Omics Data Bank

BEGIN
VPD_UTIL.ADD_VPD_CONFIG    (I_CONFIG_NAME  =>	'GROUP1_PATIENTS_ALL_PII' ,
	I_PT_ADD     =>	'Y'                                    ,
	I_PT_CONSENT =>	'Y'                                    ,
	I_PT_DATE    =>	'Y'                                    ,
	I_PT_DX      =>	'Y'                                    ,
	I_PT_ENC     =>	'Y'                                    ,
	I_PT_HIST    =>	'Y'                                    ,
	I_PT_ID      =>	'Y'                                    ,
	I_PT_MED     =>	'Y'                                    ,
	I_PT_NAME    =>	'Y'                                    ,
	I_PT_OBSV    =>	'Y'                                    ,
	I_PT_PROC    =>	'Y'                                    ,
	I_PT_SPEC	    =>	'Y'                                    ,		
I_PT_ODB    =>	'Y'                                    ,
I_DESCRIPTION  =>	'data access policy with access to GROUP1 patients for all PII attributes and Omics Data Bank',
	I_PATIENT_GROUP  =>'GROUP1',
END;
/