10 Extending PMDA (R3) Report

Database Layer

Objects specific to BIP Periodic Reporting are present in a separate schema created during the installation of the Argus Safety database. This schema only has a limited set of objects and access privileges. The following graphic illustrates these objects and privileges.

The parameters with UI = Y is passed from Argus Safety UI.

PMDA paper reports have fixed report format and style. However, they can be customized from the BIP perspective.

Extending the BI Publisher Data Model

Query 1: Q_PMDA: This query fetches data from gtt_rpt_expd_xml where the modified XML data is present.

SELECT x.e2b_xml.getClobVal() col from gtt_rpt_expd_xml x where report_id=:PN_REPORT_ID

Query 2: Q_LAB: This query fetches lab data from gtt_lab tables which get populated from the XML.

select CASE is_header WHEN 0 THEN testname||CASE WHEN Testnamellt IS NOT NULL THEN '('||Testnamellt||')' END ELSE testname END testname,

testunit, lowtestrange, hightestrange, testresult, testdate1, testdate2, testdate3

from gtt_rpt_expd_lab_mat

where report_id = :pn_report_id

order by header_seq_num, data_ord_num

Query 3: &Q_FAX_HEAD, Lexical parameter where the query resides in the package.

SELECT VALUE Q_FAX

FROM Cmn_Profile

WHERE KEY = CASE :PN_REPORT_FORM_ID

WHEN 81 THEN 'MKT_FORM_1_2_J'

WHEN 82 THEN 'MKT_FORM_3_4_J'

WHEN 83 THEN 'MKT_FORM_5_6_J'

WHEN 84 THEN 'INV_FORM_1_2_J'

WHEN 85 THEN 'INV_FORM_3_4_J'

WHEN 86 THEN 'INV_FORM_5_6_J'

ELSE ''''

END

AND NVL(:PN_PRT_FAXHEADER, 0) = 1;

Query 4: To print the report title the below function is called in the query.

select pkg_expd_rpt.f_get_pmda_title(:PN_REPORT_FORM_ID) TITLE from dual;

Query 5: &Q_WMARK

SELECT NVL(default_value,'Draft') Q_MARK

FROM cfg_rpt_agg_params

WHERE report_template = (SELECT b.display_value

FROM code_list_detail_discrete a, code_list_detail_discrete b

WHERE a.code_list_id = 'LM_REPORT_FORMS_EXPEDITED'

AND a.decode_context='REPORT_FORM_ID'

AND b.decode_context='BIPREPTYP'

AND a.code_list_id = b.code_list_id

AND a.code = b.code

AND a.display_value = :PN_REPORT_FORM_ID)

AND parameter = 'PN_PRINT_AS'

AND :pn_print_as = 1;

There are no lexical parameters used in PMDA reports.

Extending through E2B PMDA Profile

1. Modifying the Profile: Using the screenshot below as reference, modify any element for which validation category is Do not Enter to say Optional.Here, the element mhlwadmicsrremarks1 has been modified.

   
   

2. Make sure the correct Profile is selected for your agency.

   
   

3. Create a case with the remarks entered.

   
   

4. Before profile modifications, the mhlwadmicsrremarks element does not have the remarks1 column.

   
   

5. After executing the report with correct agency, the remarks column is updated in the XML.

   
   

Configuring Blinding for PMDA (R3)

10.4 Configuring Blinding for PMDA (R3)

Go to Argus Console -> Manage Profile -> PMDA (R3) profile.

Select an element for which blinding option is to be checked. Check the Blind in PMDA AE Paper Report.

The elements for which the check box is checked always print blinded information to the restricted user. Whereas for the privileged user, the Print Blinded parameter is applicable based on this value and either blinded or un-blinded information is displayed in the report.

For example, consider the DTD element DRUGAUTHROIZATIONHOLDER.

By updating the cfg_e2b table, the Blind in PMDA AE Paper Report checkbox is enabled.

Execute the following update statements by logging in as an ARGUS_APP user.

Execute the statements for a particular (R3) profile.

UPDATE cfg_e2b
   SET blind_pmda_ae_paper_rpt = 1
 WHERE profile = 'AAR_PMDA_R3_PROFILE' and dtd_element = 'DRUGAUTHORIZATIONHOLDER';

 UPDATE cfg_e2b
   SET is_blind_pmda_dtd_element = 1
 WHERE profile = 'AAR_PMDA_R3_PROFILE' and dtd_element = 'DRUGAUTHORIZATIONHOLDER';

Once updated from the profile, the checkbox is enabled.

Scenario #1: If the user executes the PMDA (R3) paper report without checking the Blind in PMDA AE Paper Report checkbox, the UnBlinded (actual) information is printed.

Actual Report

Scenario 2:

As displayed in cmn_profile, the blinded value is printed.

XML generated after checkbox checked:

Actual Report