| Oracle® Clinical Remote Data Capture Onsite Administrator's Guide Release 4.6.2 Part Number E18823-01 |
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| Oracle® Clinical Remote Data Capture Onsite Administrator's Guide Release 4.6.2 Part Number E18823-01 |
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View PDF |
This chapter describes ways to customize RDC Onsite by editing files available on the RDC Onsite application server.
This chapter includes the following topics:
You can provide a launch page for RDC Onsite, or you may have an existing Home page for your users where you would like to provide access to RDC Onsite.
The process of creating a launch page for RDC Onsite involves the following steps:
You can add a link to a Web page to start RDC Onsite in a separate browser window.
You can use the sample JavaScript and HTML to create a launch button or link that:
Opens RDC Onsite in a new browser window
Opens RDC Onsite without a toolbar or a menubar
Prevents a user from opening more than one RDC Onsite session from the same parent launch page
Note:
Oracle strongly encourages you to adapt the scripts for your use. Using the browser's Back button in RDC Onsite can cause problems in the application. By suppressing the browser toolbar, you make this button unavailable. In addition, problems can result if a user opens more than one RDC Onsite session to the same application server or from the same parent window. The sample JavaScript listed in Section 6.1.1.1 provides a link (or button) that takes no action if a session is already open.
<script language="JavaScript">
var _windowHandle = null;
var _windowStyle = 'menubar=0, toolbar=0,location=0,directories=0,status=0,menubar=0, scrollbars=1,resizable=1,copyhistory=0';
var _windowName = 'RDCOnsite';
function launchOnsite(url) {
var urlToOpen;
if (url.indexOf('?') < 0) {
urlToOpen = url + '?r=' + Math.random(); //This will ensure that page is current, not from browser cache
} else {
urlToOpen = url + '&r=' + Math.random();
}
try {
if (_windowHandle && _windowHandle.open) {
_windowHandle.focus();
} else {
_windowHandle = window.open(urlToOpen, _windowName, _windowStyle);
}
} catch (e) {
_windowHandle = window.open(urlToOpen, _windowName, _windowStyle);
}
}
</script>
The following sample HTML code creates either a RDC Onsite button or a link with functionality governed by the JavaScript in Section 6.1.1.1.
Sample HTML for Creating a Button
<input type="button" value="RDC Onsite 1" onClick="launchOnsite('URL/olsa/oc/rdcLogin.do')"/>
where URL is the URL or Web address of your application server (for example, https://computer.mycompany.com).
Sample HTML for Creating a Link
<a href="JavaScript:launchOnsite('URL/olsa/oc/rdcLogin.do')"/>RDC Onsite 1</a>
where URL is the URL or Web address of your application server (for example, https://computer.mycompany.com).
You can add optional parameters to the RDC Onsite URL to change the behavior at run time. The format of the URL is as follows:
https://server.domain/olsa/oc/rdcLogin.do?event=doSetup ¶meter1=value1¶meter2=value2¶meter3=value3
Table 6-1 describes the parameters that you can use in the URL.
Table 6-1 RDC Onsite URL Parameters
| Parameter | Description | Example |
|---|---|---|
|
db |
Specifies the database to connect to for RDC Onsite. If not specified, the application connects to the default database. Note: The database being specified here should be added to the configuration. Use this parameter to connect to a database that is not set up as the default. See Appendix A, "Setting Up Database Connections" for information about specifying the default database and ensuring that your application server can access any database you specify with this parameter. |
db=mydb |
|
debug |
Specifies whether to enable debugging and logging. all — Debugs all modules. surround — Debugs only the RDC Onsite application pages. de — Debugs only the Data Entry window. Oracle Support may ask you to use this parameter to diagnose issues. See Chapter 14, "Collecting Debug Data" for more information. |
debug=all |
|
deparams |
Oracle Support may ask you to use this parameter to diagnose possible performance issues by profiling HTML requests and responses using a value of profile. The value xhrd is reserved for possible tuning purposes. |
To be provided by Oracle Support |
|
display_descpId |
Specifies whether RDC Onsite displays the discrepancy identifier in an additional column on the Review Discrepancies page and in the Discrepancy Details window. See Chapter 14, "Collecting Debug Data" for more information. |
display_descpId=Y |
|
display_docnum |
Specifies whether RDC Onsite displays the document (CRF) number in an additional column:
See Chapter 14, "Collecting Debug Data" for more information. |
display_docnum=Y |
|
mode |
Specifies the mode in which the RDC Onsite application runs. T — Runs in test mode. P — Runs in production mode. Production mode is the default, if not specified. |
mode=T |
|
sqlTrace |
Specifies whether to enable SQL tracing.
Oracle Support may ask you to use this parameter to diagnose possible SQL issues. See Chapter 14, "Collecting Debug Data" for more information. |
sqlTrace=1 |
By default, the Login page for the RDC Onsite application does not include the Reset Password link.
You can:
Choose to show the Reset Password link on the Login page
Specify a URL for your own reset password page or use the RDC Onsite Reset Password utility
The RDC Onsite Reset Password utility uses functionality in the Oracle Thesaurus Management System (TMS). Therefore, to make use of the reset password utility:
TMS must be installed, either on the RDC Onsite application server or on another accessible server.
The TMS user IDs must match the RDC Onsite user IDs.
E-mail addresses for all RDC Onsite users must be specified in TMS using the TMS user interface. If users click the Reset Password link and their user IDs and e-mail addresses are not specified in TMS, the process fails and RDC Onsite displays an error message.
For more information on creating user IDs and specifying e-mail addresses in TMS, see the Oracle Thesaurus Management System User's Guide.
If a user attempts to log in to RDC Onsite with a valid but expired password, RDC Onsite redirects the user to the Change Password page. The password can be changed strictly through the user interface, without e-mail or involvement of TMS.
See Section 6.5.1, "Changing the URL and the Name for the Change Password Link" for more information.
You use the RdcLogos.properties file to change the default settings for the Reset Password link.
To configure the Reset Password link:
Stop the rdc OC4J instance.
Log in to the RDC Onsite application server.
Navigate to the following directory:
ORACLE_AS10gR3_HOME\j2ee\rdc\applications\olsardc \rdconsite\WEB-INF\classes\oracle\pharma\rdc\view
Open the RdcLogos.properties file with a text editor.
Find the following line in the file and set the value to true to display the Reset Password link on the Login page:
image.ResetPasswordUrlRendered=true
Specify the Reset Password page that displays when the user clicks the Reset Password link. You can specify your custom Reset Password page or you can use the RDC Onsite Reset Password page.
To specify your custom page, find the following line in the file and set the value to the URL for your Reset Password page:
image.ResetPasswordUrl=Custom_URL
To use the RDC Onsite Reset Password page:
Make sure the following line is not set to a value:
image.ResetPasswordUrl=
Set the name of the SMTP host in the following line:
resetPassword.email.smtp.host=
Specify the From e-mail address in the following line. The password notification e-mail sent to the user shows this value as the From address. For example: administrator@yourcompany.com.
resetPassword.email.from=
Check if your SMTP server requires a user name and password. If it does, enter the values in the following lines:
resetPassword.email.username=resetPassword.email.password=
Oracle uses these values to send the password reset e-mail notification. Some SMTP servers require authentication before sending e-mail using that server.
Save your changes.
Restart the rdc OC4J instance.
In the RDC Onsite application, the page header displays the Oracle logo in the upper left corner. You can customize the application to include your co-brand logo or image in the upper right corner of the page header.
To include a company or a co-brand logo on the RDC Onsite application pages:
Stop the rdc OC4J instance.
Log in to the RDC Onsite application server.
Create a GIF image file of your co-brand logo.
Copy your GIF image file to the following directory:
ORACLE_AS10gR3_HOME\j2ee\rdc\applications\olsardc\rdconsite\images
Navigate to the following directory:
ORACLE_AS10gR3_HOME\j2ee\rdc\applications\olsardc \rdconsite\WEB-INF\classes\oracle\pharma\rdc\view
Open the RdcLogos.properties file with a text editor.
Find the following two lines in the file:
image.CoBranding=images/co_brand.jpg image.CoBrandingRendered=false
Make the following changes:
Replace the co_brand.jpg file name with the name of the file you placed in the images directory.
Set image.CoBrandingRendered=true.
Save your changes.
Restart the rdc OC4J instance.
By default, the RDC Onsite application does not include the Contact Us link with the other global links that display in the page header and the page footer.
You can indicate whether you want the Contact Us icon to appear, and if so, its target URL.
To customize the Contact Us link:
Stop the rdc OC4J instance.
Log in to the RDC Onsite application server.
Navigate to the following directory:
ORACLE_AS10gR3_HOME\j2ee\rdc\applications\olsardc \rdconsite\WEB-INF\classes\oracle\pharma\rdc\view
Open the RdcLogos.properties file with a text editor.
Find the following two lines in the file:
image.ContactUsUrl=https://support.oracle.com/image.ContactUsUrlRendered=false
Make the following changes:
Replace the support.oracle.com Web address with the URL of the Web page that you want users to access when they click the Contact Us link.
Set image.ContactUsUrlRendered=true to display the Contact Us link in the RDC Onsite application.
Save your changes.
Restart the rdc OC4J instance.
By default, the Change Password link appears in the page header and the page footer of the RDC Onsite application pages, along with the other global links. You can customize this link to point to your own change password page by editing the RdcTexts.properties file.
In addition, using SQL commands, you can customize password profiles that affect whether the Change Password page is invoked automatically during the grace period or after the password has already expired.
Your options for customizing the Change Password link include:
By changing the URL, you can customize the page that your users see when they click the Change Password link.
You can also change the name of the Change Password link. You cannot, however, hide the link. The Change Password link always displays in the RDC Onsite application.
To customize the URL and name for the Change Password link:
Stop the rdc OC4J instance.
Log in to the RDC Onsite application server.
Navigate to the following directory:
ORACLE_AS10gR3_HOME\j2ee\rdc\applications\olsardc \rdconsite\WEB-INF\classes\oracle\pharma\rdc\view\nls
Open the RdcTexts.properties file with a text editor.
Find the following text string and specify your custom URL:
url.ChangePassword=rdcUserPreferences.do?pagetype=
Find the following text string and enter the text for the name of the Change Password link:
button.ChangePassword=
Save your changes.
Restart the rdc OC4J instance.
Passwords have a lifetime and a grace period defined by database profiles. You can set an expiration date for passwords. Accordingly, RDC Onsite prompts users to change their password as the expiration date approaches.
Users have a grace period in which to change their password. If they log in during the grace period, RDC Onsite displays a warning message that their password will expire soon and automatically redirects them to the Change Password page. Users can choose to change their password now or wait until later. RDC Onsite lets users log in.
If users do not change their password during the grace period, the password will expire. However, the opportunity to change the password still exists. If users attempt to log in with an expired password, RDC Onsite automatically redirects them to the Reset Expired Password page. In this case, users cannot continue until they successfully change their password. Users must then log in with their new password.
To ensure that the profile limits are enforced, use the following SQL command to assign a profile to a user:
ALTER USER user-name PROFILE profile-name
Whenever a user approves a CRF or a group of CRFs in RDC Onsite, the approval represents an electronic signature provided in accordance with FDA 21 CFR Part 11.
Every time the user approves a CRF or undoes the approval for a CRF, RDC Onsite issues a standard warning message. You can customize this message.
Users can select options in the Data Entry window or options on the application pages to approval CRFs. Therefore, if you decide to customize the approval warning message, make sure you change the message for both locations in the user interface.
To customize the approval warning messages for the Data Entry window:
Stop the rdc OC4J instance.
Log in to the RDC Onsite application server.
Navigate to the following directory:
ORACLE_AS10gR3_HOME\j2ee\rdc\applications\olsardc \rdconsite\WEB-INF\classes\oracle\pharma\rdc\de\resource\properties
Open the de_external.properties file with a text editor.
Modify the Approval warning message:
Find the following text string:
de.dcs.approve.signoff=
Change the text following the equal symbol (=) to the message that displays when the user approves a CRF from the Data Entry window. The default text is:
de.dcs.approve.signoff=IMPORTANT By approving this CRF page, you confirm that all data on the page is complete and correct. This approval is equivalent to an electronic signature.
Modify the Undo Approval warning message:
Find the following text string:
de.dcs.unapprove.signoff=
Change the text following the equal symbol (=) to the message that displays when the user undoes the approval from the Data Entry window. The default text is:
de.dcs.unapprove.signoff=IMPORTANT By undoing approval, you are rescinding the electronic signature on this page.
Save your changes.
Restart the rdc OC4J instance.
To customize the approval warning messages for the application pages:
Stop the rdc OC4J instance.
Log in to the RDC Onsite application server.
Navigate to the following directory:
ORACLE_AS10gR3_HOME\j2ee\rdc\applications\olsardc \rdconsite\WEB-INF\classes\oracle\pharma\rdc\view\nls
Open the RdcTexts.properties file with a text editor.
Modify the Approval warning message:
Find the following text string:
prompt.ApproveCrfWarning2=
Change the text following the equal sign (=) to the message that displays when the user approves a CRF from an application page. The default text is:
prompt.ApproveCrfWarning2=By approving this group of CRFs, you confirm that all data are complete and correct. Each approval is equivalent to an electronic signature.
Modify the Undo Approval warning message:
Find the following text string:
prompt.UnApproveCrfWarning2=
Change the text following the equal sign (=) to the message that displays when the user undoes the approval from an application page. The default text is:
prompt.UnApproveCrfWarning2=By undoing the approval of this group of CRFs, you revoke prior certification that the data was complete and correct. Each un-approval is equivalent to removal of an electronic signature.
Save your changes.
Restart the rdc OC4J instance.
In addition to customizing the approval warning messages, you can:
Disable approval from RDC Onsite. See Section 3.3.4, "Allowing Group Verifications and Approvals" for more information.
Set a timeout value for pre-population of user name for approvals. See Section 7.2, "Configuring a Timer Period for Subsequent Electronic Signatures" for more information.
By default, RDC Onsite displays the following message when you log out of the application:
You can customize this message by editing the RdcTexts.properties file. You may want to provide additional information or hints — such as exit from Internet Explorer or delete the browsing history — that users should do after logging out.
To customize the logout message for the RDC Onsite application:
Stop the rdc OC4J instance.
Log in to the RDC Onsite application server.
Navigate to the following directory:
ORACLE_AS10gR3_HOME\j2ee\rdc\applications\olsardc \rdconsite\WEB-INF\classes\oracle\pharma\rdc\view\nls
Open the RdcTexts.properties file with a text editor.
Find the following text string:
error.successfulLogout=
Change the text following the equal sign (=) to the message you see when you log out of the RDC Onsite application. The default text is:
error.successfulLogout=You are successfully logged out. Please close the window to login again.
Save your changes.
Restart the rdc OC4J instance.
A session begins when a user successfully logs in to RDC Onsite. The session ends either when the user logs out or when RDC Onsite times out due to inactivity.
By default, RDC Onsite times out after 30 minutes of inactivity. However, you can change the timeout interval to another value. If a user remains inactive in a session for the specified period of time, RDC Onsite automatically times out and logs the user out of the application.
The automatic timeout provides added security to unauthorized use of the application. If a timeout occurs, RDC Onsite prompts the user to log in again.
When determining whether to increase the session timeout to more than 40 minutes, you must consider the following issues:
High timeout values may negatively affect performance and scalability because memory usage increases as the timeout value increases. Specifically, when a session times out, the system cleans out all resources assigned to the user. Increasing the timeout value means the system continues to use resources for a longer time. However, if the number of concurrent users accessing the system is low (that is, 25–50), you may not notice that resources are used for a longer time, and therefore, you may not experience any resource problems. Furthermore, if you have correctly configured your server for the number of users accessing the system, you should not experience any problems with memory or CPU resources.
The value for the jbo.ampool.maxinactiveage setting in the bc4j.xcfg file must be set higher than the session timeout. The default value for this setting is 60 minutes. Therefore, you must also edit the jbo.ampool.maxinactiveage setting if you set the session timeout to more than 59 minutes.
For additional information about the various configuration settings that you can use to improve the performance of the RDC Onsite application, consult the following white paper on My Oracle Support:
Document Name: Configuring Oracle Clinical Remote Data Capture Onsite 4.6.2 for Performance and Scalability
Document ID: 1300850.1
To change the timeout interval for an RDC Onsite session:
Stop the rdc OC4J instance.
Log in to the RDC Onsite application server.
Navigate to the following directory:
ORACLE_AS10gR3_HOME\j2ee\rdc\applications\olsardc\rdconsite\WEB-INF
Open the web.xml file with a text editor.
Find the following lines in the file:
<session-config> <session-timeout>30</session-timeout></session-config>
Change the session timeout value. The default value is 30 minutes.
Note that if you set the session timeout to more than 59 minutes, you must also change the value for the jbo.ampool.maxinactiveage setting in the bc4j.xcfg file to be greater than the value of the session timeout. For more information, see Section 6.8.3, "Adjusting the jbo.ampool.maxinactiveage Setting."
Save your changes.
Restart the rdc OC4J instance.
The jbo.ampool.maxinactiveage setting, which is 60 minutes by default, must be higher than the session timeout. Therefore, you need to modify the default value for the jbo.ampool.maxinactiveage setting only if you set the session timeout to more than 59 minutes.
To change the jbo.ampool.maxinactiveage setting:
Stop the rdc OC4J instance.
Log in to the RDC Onsite application server.
Navigate to the following directory:
ORACLE_AS10gR3_HOME\j2ee\rdc\applications\olsardc\rdconsite\WEB-INF \classes\oracle\pharma\rdc\model\services\common
Back up the current bc4j.xcfg file.
Open the current bc4j.xcfg file with a text editor.
Find the following line in the file:
<jbo.ampool.maxinactiveage>3600000 </jbo.ampool.maxinactiveage>
The default value is 3600000 milliseconds, which equals 60 minutes.
Change the value.
The jbo.ampool.maxinactiveage value must be set higher than the session timeout value defined in the web.xml file.
Save your changes.
Restart the rdc OC4J instance.
By default, RDC Onsite retrieves a maximum of 1000 rows of data (records) whenever you open the Home page or execute a search.
You can change the default value by adding the Max_rows_fetched parameter to the web.xml file. You specify the maximum number of rows that RDC Onsite can retrieve from the database at a time. When you execute a search, RDC Onsite issues a warning message to adjust the search criteria if your query would retrieve more rows than the maximum number allowed.
To change the maximum number of rows fetched:
Stop the rdc OC4J instance.
Log in to the RDC Onsite application server.
Navigate to the following directory:
ORACLE_AS10gR3_HOME\j2ee\rdc\applications\olsardc\rdconsite\WEB-INF
Open the web.xml file with a text editor.
Insert the following lines into the file:
<context-param> <param-name>Max_rows_fetched</param-name> <param-value>1000</param-value></context-param>
Make sure the XML syntax is preserved when you insert these lines.
Change the maximum number of rows fetched. The default value is 1000.
Save your changes.
Restart the rdc OC4J instance.
The installation process for RDC Onsite creates the following directory:
ORACLE_AS10gR3_HOME\j2ee\rdc\applications\olsardc\rdconsite\custompages
Use this directory to save the custom Web pages that you create for CRF online help and for the Links section on the Home page.
For information on creating and maintaining links, see Chapter 10, "Configuring Links."
Form designers can embed logos or other images in their forms.
To enable image viewing on CRFs during data entry in RDC Onsite, you can choose either to set up a central repository or to copy images to all RDC Onsite installations. For information on enabling image viewing, see the Oracle Clinical Administrator's Guide.
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