3 Study setup

To set up integration with data source systems for each study, you do the following tasks in the Administration page. Then the study configurator creates a clinical data model for each data source.

• Set up the study File Watcher to load data files
  
• Set up InForm data exchange
  
• Set up data exchange with a non-InForm clinical data system
  
• Subscribe users to job status notifications
  

Set up the study File Watcher to load data files

• Create study File Watchers
  
• Select a distributed processing (DP) server for the study File Watcher
  

Create study File Watchers

For each study, create a study File Watcher. It watches the folder you specify here for uploaded data files and loads the data into Oracle DMW.

Prerequisites

Specify the watched folder locations in a system profile. See Register root folders for File Watcher watched folders.

If you want to archive (not delete) loaded data files, specify the archive folder location. See Register root folders for File Watcher archive folders.

1. Click the Navigation icon at the top of any page and then click Administration.
2. Click the File Watcher tab.
3. Click the Add Icon.
4. Study: Select the name of the study from the drop-down list. The list includes studies with no existing study File Watcher.
5. Study Folder Name: Enter a valid UNIX case-sensitive directory name with no underscores (_) to be used as the final directory of the watched folder path after each root folder. The Study folder name must be unique within the DMW instance and you will receive an error if the name you enter is already in use.
   If you have enabled archiving and specified locations for archiving files, it creates study-specific archive folders as well as File Watcher folders.
6. Delete Files After: To permanently delete a file, enter the number of days after the load date to delete it.
   To archive the files instead of deleting them, enter a higher number here than in the archiving profile value. (See Register root folders for File Watcher archive folders.)
7. Click OK. The system creates actual folders for the study on the file system.

Next: Select a distributed processing (DP) server for the study File Watcher.

Select a distributed processing (DP) server for the study File Watcher

Prerequisites

These tasks are documented in the Oracle Health Sciences Data Management Workbench Installation Guide:

• Set up the Oracle LSH Distributed Processing (DP) Server and, as part of it, the File Watcher service. The File Watcher service detects files to be loaded.

• Define at least one DP Service Location and SAS and Text for SQL*Loader DP Server services in the Oracle LSH user interface. These services load data from files into the Oracle DMW database. See the Oracle Life Sciences Data Hub System Administrator's Guide.

• Security for the folders.

• Compatible time zone configuration on each computer. See the Oracle Health Sciences Data Management Workbench Installation Guide.

1. Click the Navigation icon at the top of any page and then click Administration.
2. Click the File Watcher tab.
3. Select a Study File Watcher and click the DP Servers for File Watchers icon.
4. Select one DP Server for each type of data file to be loaded in the study.
5. Click OK.

Set up InForm data exchange

The following sections describe how to:

• Create users for InForm integration
  
• Add InForm remote locations
  
• Add InForm web service locations
  

Create users for InForm integration

To create users for InForm integration, you need to:

• Create required Oracle accounts
  
• Create required InForm users
  

Create required Oracle accounts

On each InForm study database, run scripts to create a read-only user account for Oracle DMW to use to access data and metadata in InForm.

The account has Select privileges on all tables and views in study accounts referenced by the InForm Connector, including metadata views, operational data views, and RDE views. This schema also has packages that facilitate the data load process.

Use the credentials of this account when you set up a database connection (remote location) in the Oracle DMW InForm configuration for each study using the InForm database.

• Create Directory on Each InForm Database
  
• Copy Scripts
  
• Run the Driver Script
  

Create Directory on Each InForm Database

On each InForm database with a study for which you plan to use Oracle DMW, create one OS directory using the mkdir command to hold scripts you must copy and run.

You need one directory per database, not per study.

Copy Scripts

Copy the following files from the directory $CDR_TOP/patch/115/sql/ on the computer where you have installed Oracle Life Sciences Data Hub to the InForm database directory you created.

• DMWInFormInstall.sql—the driver script

• DMWInFormUser.sql—creates new users or confirms existing users

• DMWInFAdms.pls—installs a package specification into the Oracle DMW administration account

• DMWInFAdmb.pls—installs a package body into the Oracle DMW administration account

• DMWInFormROAccessObjs.sql—installs a table into the Oracle DMW read-only access account

• DMWInFroas.pls—installs a package specification into the Oracle DMW read-only access account

• DMWInFroab.pls—installs a package body into the Oracle DMW read-only access account

Run the Driver Script

The driver prompts for all required input parameter values and calls the other scripts as required.

1. Log into SQL*Plus with an account with DBA privileges.

2. Go to the directory that contains the downloaded scripts.

3. Execute DMWInFormInstall.sql. The script prompts for:

   • A name to give the log file.
   • TNS name or connect string for the InForm database. If you enter the connect string, do not enter any spaces.
   • system or other DBA username and password.
   • Name of the Oracle DMW Admin account to be used or created for the purpose of giving privileges to the Oracle DMW read-only access account. The system creates the account if it does not already exist.
   • Name of the Oracle DMW read-only access account to be used or created. The system creates the account if it does not already exist.

     Tip:

     Do not use spaces or special characters other than underscore (_) in the username or password.
   • Passwords for both accounts. If the accounts are new, the script prompts you to confirm each password. If the accounts already exist, you must enter a password, but the system does not change the existing password. It proceeds to create or update the packages owned by the schema.
   • If the read-only access account is new, the script also prompts for a tablespace name. It then creates a tablespace on the InForm database to be used for the integration with Oracle DMW and creates or updates all Oracle DMW objects in this tablespace.

Create required InForm users

For each InForm study:

1. Log in to the system you use to create InForm user accounts:

   • If your InForm installation is on-premise, use UMT.
   • If your InForm installation is hosted by Oracle, use Single Sign-on.

2. Create a user with a suggested username DMW_AUTH to be used for authentication purposes by the web service connection. This user does not need any privileges. You enter this username and password when creating web service locations.

3. Create a user with the required username DMW_QUERY (in UPPER CASE) to be used for sending and updating discrepancies in InForm. Assign this user to a query group. The password for this user is not used in Oracle DMW.

4. Activate both accounts.

Add InForm remote locations

Database links are used to load data and metadata from InForm to DMW.

When defined here, they are available for use in an InForm clinical data model. Alternatively, study configurators can create and edit them in the clinical data model.

1. Click the Navigation icon at the top of any page and then click Administration.
2. Make sure the Data Sources tab is selected, then click the InForm Remote Locations subtab.
3. Click the Add icon or Modify icon.
4. Enter:

   • Name: A name for the InForm database. It cannot contain spaces, slashes, or special characters other than underscore (_). This is displayed for study configurators.

     Tip:

     Include the study name and lifecycle stage in the name to make it easy for the study configurator to select.

   • ConnectString: The text of the Using clause of the Create Database Link SQL statement. This is normally the same as the Description Clause of a TNSNAMES definition—for example:

     (DESCRIPTION=(ADDRESS=(PROTOCOL=TCP)(HOST=host_name.company_domain.com)(PORT=1521))(CONNECT_DATA=(SERVER=DEDICATED)(SERVICE_NAME=trial_name.world)))

     Tip:

     It cannot contain spaces.

   • Username: The name of the DMW read-only access account in the InForm database for this remote location; see Create required Oracle accounts for details. The system will use this account to connect.

   • Password: Enter the password of the account. The system changes and encrypts the password after creating the database link.

     In the unlikely event that you need to change the password, your InForm database administrator must change the password for the Oracle DMW read-only access account. You can then select Enable Password Entry? in the Edit Remote Location window and enter the new password. The system then recreates the database link and changes and encrypts the password.

     Note:

     If you delete the remote location and create a new one with the same username, you must change the password in the InForm database first and then enter it here.

5. Click Test Connection to make sure it is set up correctly.
6. Click OK.

Next: Add InForm web service locations.

Add InForm web service locations

Web services are used to send discrepancies from DMW to InForm.

When created in the Administration page, they are available for use in the appropriate InForm study clinical data model. Alternatively, they can be created and edited in the clinical data model.

1. Click the Navigation icon at the top of any page and then click Administration.
2. Make sure the Data Sources tab is selected, then click the InForm Web Service Locations subtab.
3. Click the Add icon or Modify icon.
4. Enter Web Service Location attributes.

   • Name: Enter any name for the web service location.

     Tip:

     Include the study name and lifecycle stage in the name to make it easy for the study configurator to select.

   • Web Service URL: Enter the URL for the study's InForm website.

     http://your_InForm_server.your_company.com/your_trial/pfts.dll

   • Authentication Trial Name: Enter the study name exactly as it appears in the URL.

   • SSO Organization: For an on-premise installation, do not enter anything here. Doing so will cause harm.

     If your InForm installation, specifically the InForm Adapter, is hosted by Oracle, enter the organization associated with the DMW_QUERY user as provisioned for Single Sign-On use.

   • Username: The name of the account set up for authenticating DMW web service transactions. See Create required InForm users for details.

     The suggested name is DMW_AUTH.

     Note:

     • The Username and Password fields are not displayed if DMW is installed using HTTP, not HTTPS.
     • Do not use spaces or special characters other than underscore (_) in the username or password.

   • Password: Enter the password required for the same user account. The system encrypts the password.

5. Click Test Connection to test without saving, or Test and Save.

Set up data exchange with a non-InForm clinical data system

• Set up File Watcher
  
• Add a web service location for a non-InForm clinical data system
  

Set up File Watcher

If you are using a clinical data system other than InForm, you must load data from that system in files. Follow instructions in "Set up the study File Watcher to load data files".

Add a web service location for a non-InForm clinical data system

If you are using a clinical data system other than Oracle InForm, define a web service location to enable Oracle DMW to send discrepancies to it and to enable data reviewers to open the external system from DMW to view data and discrepancies there.

1. Click the Navigation icon at the top of any page and then click Administration.
2. Make sure the Data Sources tab is selected, then click the External Data Sources subtab.
3. Click the Add Icon.
4. Enter Web Service Location attributes.

   • Name: Enter any name for the web service location.

   • Data Model Sub Type:

   • Username: The name of the account set up for authenticating DMW web service transactions.

     The suggested name is DMW_AUTH.

     Note:

     • Do not use spaces or special characters other than underscore (_) in the username or password.
     • The Username and Password fields are not displayed if DMW is installed using HTTP, not HTTPS.

   • Password: Enter the password required for the same user account. The system encrypts the password.

5. Click OK.

Subscribe users to job status notifications

You can specify that certain users receive notifications whenever a particular type of job completes with a particular status in a particular study. Users can also set up their own notifications on the Home page.

User accounts that become inactive or accounts that lose privileges for the target study are automatically unsubscribed from notifications.

Prerequisite

If you haven't already, follow the instructions in My Oracle Support article 164871.1, "Configuring the Workflow Notification Mailer(s) in Oracle Applications Manager 11i" as directed in the Oracle Life Sciences Data Hub Installation Guide.

1. Click the Navigation icon at the top of any page and then click Administration.
2. Click the Notification Subscription tab.
3. In the Study Name list, select the study for which you want to set up notifications.

   Tip:

   Type a study name in the search box directly above the list and press Enter to find a particular study.

   To stop filtering, delete the filter name and click Refresh.

4. In the Notification Events list, select one event for which you want the system to send notifications:

   • Job types: File loads, InForm loads, Transformations, Validation Checks

   • Completion statuses: Success, Warning, Failure

   The Subscribed Users list displays the users who currently receive email notifications when a job completes with the selected status for the selected study.

5. Click the Subscribe/Unsubscribe Users icon on the Subscribed Users title bar.
6. Select the checkbox to the left of a user to subscribe them to notifications for the selected study and event.

   Tip:

   You can use the search box directly above a column to search in that column or click on the column heading to sort by it.

   To unsubscribe users, deselect the checkbox.

7. Click Save.