Oracle® Health Sciences WebSDM and Empirica Study Installation Instructions Release 3.1.2.1 for Windows 2003/2008 Server E40537-03 |
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This chapter describes the activities to be performed post installation.
Install each version of MedDRA used by the studies that you plan to load into WebSDM. Even if your own studies do not use MedDRA version 11.0, install version 11.0 because the LTI sample study uses it. The sample study serves as an anchor to the standard reports feature of WebSDM.
The process described in this section creates and loads an account named MEDDRAx for each MedDRA version, where x
represents the two- or three-digit MedDRA version. For example, accounts MEDDRA70 and MEDDRA131 create and load MedDRA versions 7.0 and 13.1.
The same MedDRA account can be used by multiple WebSDM instances.
Create a folder for loading the MedDRA data (for example, c:\meddra
). This folder is referred to as <meddra_base> in the instructions that follow.
For each MedDRA version that you plan to load, you need two zip files:
WebSDM MedDRA Dictionary zip file
Locate the WebSDM MedDRA Dictionary zip file for the MedDRA version on the WebSDM Installation media.
The zip file is named MEDDRAx.zip
where x
represents the two- or three-digit MedDRA version.
MSSO MedDRA Dictionary zip file
Obtain the licensed MedDRA Dictionary zip file for the MedDRA version from the MedDRA MSSO (Maintenance and Support Services Organization, http://www.meddramsso.com
).
For each MedDRA version you need to load, complete the following steps, where x represents the two- or three-digit MedDRA version.
Unzip the WebSDM and MSSO Dictionary files:
Unzip MEDDRAx.zip from the WebSDM installation media into <meddra_base>
. This creates a folder named <meddra_base>\MEDDRAx\
containing several files and two subfolders named ctrl
and MedDRA
.
Unzip the zip file from MSSO containing the correct MedDRA version into <meddra_base>\MEDDRAx
. This creates a folder named <meddra_base>\MEDDRAx\MedDRA\medascii
containing the *.asc data files.
Edit the following files in folder <meddra_base>\MEDDRAx
using a text editor. Save and close each file after editing.
Create_MedDRA.sql
Review the DEFINE ORACLE
statements. By default, this script stores tablespace files in a subfolder of oradata
named orcl (..\oradata\orcl
). Edit the path used by the DEFINE ORACLE_DBF_FILE
statement, if necessary, to indicate a different location.
You must specify a path that already exists on your computer. The path can be in any location, although it is typically in a subfolder of oradata
.
Load_MedDRA.imp
Change the Oracle net service name at the end of the line userid=MEDDRAx@orcl
from orcl to the value of <ora_net_service>.
Restore_meddra_terms.bat
Change the name of the Oracle net service at the end of the ninth line:
SET SID=ORCL
from orcl to the value of <ora_net_service>.
Open a command window and change to the <meddra_base>\MEDDRAx
folder. Execute the following commands:
Execute the Create_MedDRA.sql
script from an account with DBA privileges.
C:\> sqlplus <ora_dba_acct>@<ora_net_service> @Create_MedDRA.sql
When prompted for the password, enter <ora_dba_pass>. The script also prompts you to supply a password for the new MedDRA account. Supply the value of <meddraX_ora_pass>.
Execute the batch file: Load_MedDRA.bat.
When prompted for the password of the newly created MedDRA account, supply the value of <meddraX_ora_pass>.
The file imp_MEDDRAx.log
is produced. You can compare its row counts with those in the provided file exp_MEDDRAx.log
. The row counts should be the same.
Execute the batch file restore_meddra_terms.bat
.
You are again prompted to supply the password of the new MedDRA account. As the script completes, you can verify the row count checks displayed on the screen.
Clean up the file, if errors occur.
If errors occur while running the supplied MedDRA account installation scripts, you can correct the problem, clean up, and start over by running the Drop_MedDRA.sql
script in the respective MEDDRAx
folder. Execute the script from an account with DBA privileges, and supply <ora_dba_pass> when prompted for the password.
C:\> sqlplus <ora_dba_acct>@<ora_net_service> @Drop_MedDRA.sql
To enable standard report definitions that are supplied for WebSDM, you must install a sample application and study. Installation of MedDRA 11.0 is a prerequisite for this procedure. One sample study is required to enable the standard reports features of the software, and is referenced in the Operational Qualification test supplied on the installation media.
Locate the LTI_Sample_Application.zip
file on the installation media, and extract the contents of this file to a location on the machine where WebSDM is installed, under the Root directory <submissions_folder> specified on the Site Options page. To make sure that path names stored in the archive are used, specify the appropriate option when extracting (for example, in WinZip, select the Use folder names checkbox).
Log into WebSDM as a Superuser.
Click the Setup tab, and then click Register Application.
For the Name property, specify LTI. The sample study requires this exact application name to function properly. Do not modify the application name.
For the application Path, use the Browse link and then locate and select the LTI application folder.
For Default codelists in metadata, use the supplied value, Standard Codelists.
For Default MedDRA account, specify MEDDRA110.
For Default SDTM version, specify sdm312.
When you click OK, the Auto-Register Studies page appears. Three studies, SAMP1, SAMP1_311, and SAMP1_312, are offered for automatic registration.
For Study SAMP1 and Study SAMP1_311, use the drop-down control to select Defer study registration.
For Study SAMP1_312, keep the default value, Generate a new metadata file with standard codelists.
To begin automatic registration, click OK.
When registration is complete, click Continue.
The Applications page appears, with the entry LTI.
From the LTI actions menu, click Load.
On the Select Studies/Pools to Load page, select the Include checkbox for study SAMP1_312.
Click Next, Next, and Submit to begin the run.
Click Continue, and occasionally refresh the Run History page to view the run status. After a few minutes, the run completes.
The required sample study that was registered and loaded in the previous steps is compliant with CDISC SDTM version 3.1.2. You can install additional sample studies that are compliant with CDISC SDTM versions 3.1 and 3.1.1, respectively. Section 3.2.2, "Optional: Registering Other LTI Sample Studies" and Section 3.2.3, "Optional: Loading the Optionally Registered Studies" are optional.
Perform the steps below to register other LTI sample studies.
Click the Setup tab, and then click Studies > Pools.
From the Application drop-down list, select LTI.
Click Register Study.
For the Name property, specify SAMP1 (or SAMP1_311).
For the SDTM version, specify sdm31 (or sdm311).
Accept the MedDRA account, MEDDRA110.
For the Data location, use the Browse link and navigate to \crt\datasets\
. On the row for SAMP1 (or SAMP1_311), click Select.
Accept the Metadata value. Generate a new metadata file with standard codelists.
Click Generate Metadata, and click OK to confirm.
The application creates the metadata file and adds the name to the Metadata field.
Click OK.
On the Studies and Study Pools page, on the Action menu, click Load.
Click Next.
Click Next.
Click Submit.
Click Continue, and occasionally refresh the Run History page to view the run status. After a few minutes, the run completes.
Repeat steps 1 through 5 to load each registered study.
Click Exit to log out of WebSDM.
You can customize WebSDM by making one or more of the following alterations. For more detailed instructions, see the WebSDM Help.
A default home page appears when users log into WebSDM. Another home page file is supplied for use by installations that license the optional Empirica Study features. You can replace either of the home pages with a custom home page. You can create a single home page for all users, or specify a different customized home page for each WebSDM login group.
Use an HTML editor to design each new home page, and save it as an HTML file.
Use a text editor to remove the <body>
tag at the beginning of the file and the </body>
tag at the end of the file, leaving all other HTML content that occurs between those tags intact.
Save the edited file with the extension, .inc., in the following directory:
<root>\Lincoln\apps\<instance>\webapps\web_root\customhomes\
For example, EStudy_home.inc
is the name of the home page file that is supplied for use by installations using the Empirica Study application.
Log into WebSDM as a user with the Administer Users permission.
Click Settings.
Click Edit Login Groups.
Supply the name of the home page file in the customhomes\
directory that should appear when the members of this login group log in to WebSDM.
Note: If more than one login group is set up in WebSDM, repeat this procedure for each login group. |
A logotype appears in the upper left corner of WebSDM pages. An additional logotype file is supplied for use by installations that license the optional Empirica Study features. You can replace either of the logotypes delivered with WebSDM with a logotype of your own design. You can create a custom logotype for all users, or specify different logotypes for each WebSDM login group.
Select a .bmp
or .gif
file with dimensions of approximately 150x100 pixels and copy it to the <root>\Lincoln\apps\<instance>\webapps\Web_root\image
directory. For example, E_logo.gif
is the image file that is supplied for use by installations with the Empirica Study application.
Log into WebSDM as a user with the Administer Users permission.
Click Settings.
Click Edit Login Groups and supply the name of the logotype file in the image\
directory that appears for members of this login group.
Note: If more than one login group is set up in WebSDM, repeat steps 3 and 4 for each login group. |
When you register an application in WebSDM, you can select an FDA review division for that application from a dropdown list. This list is populated with values from the FDA_REVIEW_DIVISIONS table owned by <websdm_master_acct>. You can add values to the list of FDA review divisions.
If new review divisions are created, complete the following steps to add the new divisions:
Launch SQL*Plus and connect using the <websdm_master_acct>.
Execute one or more SQL statements in the following form:
INSERT INTO FDA_REVIEW_DIVISIONS (REVIEW_DIVISION, ORDER_BY) VALUES('[new review division]', [sequence number]);
Commit your changes.
New values are immediately available for selection in WebSDM on the Register Application page.
Exit SQL*Plus.
When you register an application or study in WebSDM, WebSDM creates an Oracle database account for the application or study. These accounts are associated with the Oracle database profile named DEFAULT, unless you create an alternate profile and direct WebSDM to use that profile instead.
For guidelines on creating an alternate profile for your application and study accounts, see Appendix B, "Optional: Creating Alternate Profiles".
After you have created an alternate profile, you must specify that WebSDM is to use it for new study accounts:
Log in to WebSDM as an administrator.
Click Settings.
Click Set Site Options.
In the Database Accounts and File System Structure section, select the appropriate Profile for new Accounts.