1 Setting up EOSU Database

This chapter provides information about setting up the EOSU database and includes discussions of the following:

• Creating the Spool/Log Directory

• Setting Up the ARGUS_EOSU Schema

• Creating an End of Study Unblinding Argus Group

• Suggestions for Improving Performance

Creating the Spool/Log Directory

The processes executed under Argus-EOSU interface (except the Oracle Jobs) prompts for a directory to spool log file. We recommend creating a single directory with plenty of disk space (8-10 GB free) as a spool directory (for example, C:\ARGUS_EOSU _LOGS).

Setting Up the ARGUS_EOSU Schema

The ARGUS_EOSU Schema creates Oracle objects required for the EOSU interface in the Argus database, where EOSU has never been installed, under the ARGUS_EOSU Oracle user.

To set up the ARGUS_EOSU schema:

1. Select Start=> Programs=> Oracle=> End of Study Unblinding or select the Start Menu Option > Programs > Oracle > End of Study Unblinding > Database > Create EOSU Schema 10g (or "Create EOSU Schema 11g") depending on the version of the Oracle Client installed on the machine.

2. When the Oracle SQL*Plus screen opens:

   • Type the TSNAMES entry to connect to the Argus Database.

   • Type the User SYS Password.

   • Type the Argus Schema User Name.

   • Type the ARGUS_APP Password.

   • Type the Argus Safety Role Name.

   • Type the Argus-EOSU User Password.

   • Type the Temporary Tablespace name for ARGUS_EOSU.

   • Type the name of the Tablespace to hold the ARGUS_EOSU tables and indexes.

   • Type the Destination Directory Name in which to create the log file. This name cannot contain spaces, tabs, or other special characters.

   • Type the Log File Name. This name cannot contain spaces, tabs, or other special characters.

3. When the Oracle SQL*Plus screen shows that the ARGUS_EOSU user has been successfully created:

   • Press Enter.

4. When the Oracle SQL*Plus screen shows End of Schema Creation: Press Enter to terminate the setup and check log file for any errors. Ignore drop errors on commands like "Public Synonyms", "Local Synonyms" and "Drop User".

   • Press Enter to terminate set up.

5. Review the LOG files for any errors/warnings. Resolve all errors before proceeding further.

   Note:

   Ignore drop errors on commands such as Public Synonyms, Local Synonyms, and Drop User.

Creating an End of Study Unblinding Argus Group

Use the following procedure to create an EOSU Argus Group. The group you create is assigned to Argus users who use EOSU Generic.

To create an EOSU Argus Group:

1. Log in to Argus Safety Application as an Administrator.

2. Go to Argus Console=> Access Management=> Groups and Users.

3. Add a new group called End of Study Unblinding.

Suggestions for Improving Performance

You can improve performance (database response time) while using EOSU. Consider doing the following:

• Generate Statistics Periodically

  Generate Statistics under the Argus Schema Owner (typically named as ARGUS_APP or G001SCHEMA) on a periodic basis. Generate statistics for the tables and indexes under the ARGUS_EOSU user.

• Creating extra Indexes for Argus.

  A function called f_ulrztrim is created under ARGUS_EOSU when the ARGUS_EOSU schema is created. This function is used to search/select from ARGUS/EOSU schemas whenever loading or using Randomization Data.

  To increase the performance of the Randomization Data load and processing cases, create Function Based Indexes in Argus schema.

  A script below also allows you to drop indexes if necessary. Note that Argus Indexes must be dropped before you drop the EOSU schema from the database. Failure to do so will cause errors while saving data in Argus Application.

  Note:

  Each time the schema is created the Indexes are dropped and must be manually created.

--- To Create Function Based Indexes
--- EXECUTE as System User
--- Replace ARGUS_APP in the "define" statement below with Argus Schema Owner (e.g. ARGUS_APP or G001SCHEMA users)
--- This should be executed after the ARGUS_EOSU schema has been created
---
define ARGUS_USER = 'ARGUS_APP';
 
begin
        execute immediate 'ALTER SESSION SET QUERY_REWRITE_INTEGRITY = TRUSTED';
        execute immediate 'ALTER SESSION SET QUERY_REWRITE_ENABLED = TRUE';
        execute immediate 'ALTER SESSION SET OPTIMIZER_MODE = CHOOSE';
exception
when others then
     NULL;
end;
/
 
create index &ARGUS_USER..fbi_lmst_study_num on &ARGUS_USER..LM_STUDIES ( substr (f_ulrztrim (STUDY_NUM), 1, 1000 ) )
storage (initial 4m next 1m maxextents unlimited);
 
create index &ARGUS_USER..fbi_lmco_COUNTRY on &ARGUS_USER..LM_COUNTRIES ( substr (f_ulrztrim (COUNTRY), 1, 1000 ) )
storage (initial 4m next 1m maxextents unlimited);
 
create index &ARGUS_USER..fbi_lmct_CENTER_NO on &ARGUS_USER..LM_CENTERS ( substr (f_ulrztrim (CENTER_NO), 1, 1000 ) )
storage (initial 4m next 1m maxextents unlimited);
 
create index &ARGUS_USER..fbi_lmct_CENTER_NAME on &ARGUS_USER..LM_CENTERS ( substr (f_ulrztrim (CENTER_NAME), 1, 1000 ) )
storage (initial 4m next 1m maxextents unlimited);
 
create index &ARGUS_USER..fbi_cspi_RAND_NUM on &ARGUS_USER..case_pat_info ( substr (f_ulrztrim (RAND_NUM), 1, 1000 ) )
storage (initial 4m next 1m maxextents unlimited);
 
analyze index &ARGUS_USER..FBI_LMST_STUDY_NUM compute statistics;
analyze index &ARGUS_USER..FBI_LMCO_COUNTRY compute statistics;
analyze index &ARGUS_USER..FBI_LMCT_CENTER_NO compute statistics;
analyze index &ARGUS_USER..FBI_LMCT_CENTER_NAME compute statistics;
analyze index &ARGUS_USER..FBI_CSPI_RAND_NUM compute statistics;
 
---
--- To Drop Function Based Indexes
---
--- EXECUTE as System User
--- Replace ARGUS_APP in the "define" statement below with Argus Schema Owner (e.g. ARGUS_APP or G001SCHEMA users)
--- This should be executed after the ARGUS_EOSU schema has been created
---
define ARGUS_USER = 'ARGUS_APP';
drop index &ARGUS_USER..FBI_LMST_STUDY_NUM;
drop index &ARGUS_USER..FBI_LMCO_COUNTRY;
drop index &ARGUS_USER..FBI_LMCT_CENTER_NO;
drop index &ARGUS_USER..FBI_LMCT_CENTER_NAME;
drop index &ARGUS_USER..FBI_CSPI_RAND_NUM;
 

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