For MedDRA 19.1 and later

Data from the Oracle Argus Mart application is timestamped. Therefore, you must create a MedDRA user account for MedDRA 19.1 and later to code the data.

1. Copy the MedDRAxxx.zip file from the distribution media to a temporary directory on the server.
2. Unpack the MedDRAxxx.zip file into a temporary directory, for example:
   $ unzip MedDRAxxx.zip -d /u01/stage/

   The MedDRAxxx subdirectory is created.

3. Navigate to the MedDRAxxx/Linux directory, for example:
   $ cd /u01/stage/MedDRAxxx/Linux
4. Give execute permissions on the shell script files:
   $ chmod +x *.sh
5. Execute the installer:
   $ ./install.sh
6. Follow the on-screen prompts to install MedDRA xx.x.

   The following is a sample transcript of the prompts and information that the installer generates.

Pre-installation checks

The installer performs a series of checks to ensure that the required software components are available.

Empirica Signal Data Release Installation Program Version <version>
Pre-installation checks:
  sqlplus ................................................ INSTALLED
  imp .................................................... INSTALLED
  tnsping ................................................ INSTALLED
  builtin echo ........................................... AVAIL.
  builtin printf ......................................... AVAIL.

Oracle TNS name

The installer prompts for the target TNS name, which will be used in the rest of the steps.

Enter the TNS name and press Enter.

Please enter your database's TNS name:

The installer attempts to verify the TNS name provided. After three failed attempts, the installer will terminate with an error. If verified, the installer indicates success.

TNS name <TNS NAME> verified successfully.

Password for privileged Oracle user

Creating and dropping schemas requires elevated privileges. The installer prompts for a privileged Oracle user account name. The default privileged Oracle user account name is SYSTEM.

Please enter Privileged user’s Oracle user name [SYSTEM]:

Enter the password for this account and then press Enter.

Your response will not be echoed to the screen but will be masked by a series of asterisks.

Please enter SYSTEM's password:

The installer attempts to verify the password provided. After three failed attempts, the installer will terminate with an error. If verified, the installer indicates success.

SYSTEM password verified successfully.

Oracle Empirica Signal or Oracle Empirica Study application user name (not applicable for MedDRA 19.1)

If Oracle Empirica Signal or Oracle Empirica Study is installed, press Enter.

Is an Empirica application installed in the target database <TNS NAME> [Y|N]?

Enter the Oracle user name (for example, WEBVDME or STUDY) and password for the application when prompted.

Please enter Empirica application’s Oracle user name [WEBVDME]:

Please enter WEBVDME's password:

If verified, the installer indicates success.

WEBVDME password verified successfully.

Installation

The installer presents the option to install the MedDRA xx.x data account. If the data account already exists, drop and re-install the account. Press Enter or enter Y to install MedDRA xx.x, or enter N to skip.

Install MEDDRA xxx [Y|N]?

Enter a secure password for the MEDDRAxxx Oracle user, subject to any site-specific policies or restrictions.

Note:

Your site’s database may have specific password policies or restrictions. For example, your database may not allow the password to be the same as the account name. Take this into account when choosing the password for this account.

Your response will not be echoed to screen but will be masked by a series of asterisks.

Please enter a new password for MEDDRAxxx:

Enter the same password for verification. Your response will once again be masked by a series of asterisks. After three failed attempts, the installer will terminate with an error. If verified, the installer continues.

Please re-enter the same password for verification:

Enter the full directory path for datafiles on your database server or press Enter to accept the default.

Note:

The installer does not have the ability to verify remote system paths. Please make sure that the path you are entering is correct. Linux file and directory paths are case sensitive and use forward slashes to separate path components.

Please enter the absolute datafiles directory path [/u01/app/oradata/ORCL]:

Data review

The installer presents all of the information it has collected. Passwords are masked by a series asterisks. Inspect the list carefully before proceeding. If necessary, press Ctrl+C to abort the installation and retry with the corrected information. If the information is correct, press any key to proceed with the installation.

Please review your selections and press any key to continue or Ctrl+C to abort:
 TNS name ........................................... ORCL
 Privileged user .................................... SYSTEM
 SYSTEM password .................................... ********
 Signal or Study user ............... ............... WEBVDME
 WEBVDME password ................................... ********
 Install MEDDRA xxx ................................. Y
 Drop MEDDRAxxx ..................................... N
 Create MEDDRAxxx ................................... Y
 Password ........................................... ********
 Datafiles Dir. ..................................... /u01/app/oradata/ORCL
 Postinstall initialization ......................... None
Please press any key to continue or Ctrl+C to abort:

Installation progress and summary

Updates are printed to the screen as installation progresses. Any errors encountered also display. For an error-free installation, the installer will report success before exiting.

Installing MEDDRA xxx ...
Creating user MEDDRAxxx ...
Schema MEDDRAxxx created successfully.
Importing data into MEDDRAxxx ...
Data imported successfully.
Computing statistics for MEDDRAxxx ...
Statistics for MEDDRAxxx computed successfully.
MEDDRA xxx installed successfully.
All data components installed successfully.

Installation produces log files in the MedDRAxxx directory, including counts of imported records for each table:

Create_MedDRA.log
imp_MEDDRAxxx.log

To verify that the import has completed successfully, compare the record counts in imp_MEDDRAxxx.log to the counts of exported records in exp_MEDDRAxxx.log.