| Oracle® Clinical Remote Data Capture Onsite Administrator's Guide Release 5.1 E53568-01 |
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PDF · Mobi · ePub |
| Oracle® Clinical Remote Data Capture Onsite Administrator's Guide Release 5.1 E53568-01 |
|
|
PDF · Mobi · ePub |
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 customize the shipped Oracle Clinical Launch page to add a link to RDC Onsite, create a new Launch page, or create a button or link to RDC Onsite from an existing website such as your users' Home page. Oracle provides scripts that help prevent problems that may arise in the RDC Onsite application; see Section 7.1.1, "Creating or Customizing a Launch Page to Use Provided Scripts."
If you have more than one database, you can customize the RDC Onsite URL to specify a database other than the one created by default during installation; see Section 7.1.2, "Customizing the RDC Onsite URL.".
Oracle recommends using the scripts provided here to control when and how the RDC Onsite Login page opens, to prevent users from having problems in the RDC Onsite application resulting from:
Using the browser's Back button—Sample Java Script for Launching in a New Window without Tool or Menu Bar suppresses the browser toolbar, making the Back button unavailable.
Turning on Internet Explorer's Compatibility View—Sample JavaScript for Checking if Compatibility View Is On detects if Compatibility View is turned on and if it is, does not open the application and displays a message telling the user to turn it off.
Opening more than one RDC Onsite session to the same application server or from the same parent window—the scripts prevent this.
To use these scripts in your launch page:
Place the script from Section 7.1.1.1, "Sample Java Script for Launching in a New Window without Tool or Menu Bar" in a file called Launch.js.
Place the script from Section 7.1.1.2, "Sample JavaScript for Checking if Compatibility View Is On" in a file called IeCompatCheck.js.
Place the scripts at the same location as the Launch page or in a folder (called JS in the example code below) in the same location as Launch page. The shipped Oracle Clinical Launch page, launch.htm, is located in opa_home/html.
Create an HTML page that contains a button or link to RDC Onsite that invokes the functions in the JavaScript files or add code to the shipped Launch page or an existing website to do the same.
Put the code referencing the scripts near the top of the HTML page; for example:
<title> Launch RDC Onsite </title> <script type="text/javascript" src="JS/IeCompatCheck.js"></script> <script type="text/javascript" src="JS/LaunchJS.js"></script> </head> <body>
Add button code or link code as follows, and see Section 7.1.2, "Customizing the RDC Onsite URL."
<script language="JavaScript">
document.write('<FORM>');
document.write('<input type="button" value="RDC Onsite" onclick="return launch(event,\'../rdcadfsrnd/faces/Login\',\'RDCOnsite\')" class="loginButton"/>');
document.write("</FORM>");
</script>
<noscript>
<a onclick="return launch(event,'../rdcadfsrnd/faces/Login',\'RDCOnsite\')" href="#">Launch RDC</a>
</noscript>
function launch(event,url,windowname){
if(detectIECompatibility(event)){
cancelEvent(event);
return false;
}
if(!!!windowname){
windowname="_blank";
}
window.open(url,windowname,'location=0,resizable=1,toolbar=0,titlebar=1,status=1,scrollbars=1,menubar=0','true');
}
The following script checks if compatibility view is on and if so, displays a message asking the user to turn it off.
function IECompatDetect(){
this.isCompatOn = function(){
var ua = navigator.userAgent;
var on = false;
for(var index=0; index< this.ieUAProps.length; index++){
var ieProp = this.ieUAProps[index];
if(ua.search(ieProp.layoutEngine) == -1){
continue;
}
if(ua.search(ieProp.browser) == -1){
on = true;
break;
}
}
return (on);
};
this.ieUAProps= [
{
browser: 'MSIE 10',
layoutEngine: 'Trident/6'
},
{
browser: 'MSIE 9',
layoutEngine: 'Trident/5'
},
{
browser: 'MSIE 8',
layoutEngine: 'Trident/4'
}
]
}
function cancelEvent(e){
var event = e || window.event;
if(event == null){
return;
}
if(event.preventDefault){
event.preventDefault();
}else{
event.returnValue=false;
event.cancelBubble=true;
}
}
function compatCheck(event,isCompatRequiredToBeOn){
var compatOn=(new IECompatDetect()).isCompatOn();
if(compatOn && !isCompatRequiredToBeOn){
cancelEvent(event);
alert("Please turn off IE's Compatibility View. Go to Tools->Compatibility View/Compatibility View Settings to do so.");
}
if(!compatOn && isCompatRequiredToBeOn){
cancelEvent(event);
alert("Please turn on IE's Compatibility View. Go to Tools->Compatibility View/Compatibility View Settings to do so.");
}
return compatOn;
}
function detectIECompatibility(e){
return compatCheck(event,false);
}
//Call on load
(function(){
compatCheck(null,false);
})();
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/rdcadfsrnd/faces/Login?setUpDone=Y ¶meter1=value1¶meter2=value2
Table 7-1 describes the parameters that you can use in the URL.
Table 7-1 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. 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 15, "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 15, "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 15, "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 15, "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.
Email 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 7.5.1, "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:
Navigate to the OPA_CONFIG_FOLDER. The folder path is determined by the registry entry opa51, found under HKEY_LOCAL_MACHINE > Software > Oracle, for example:
C:\opapps51\config
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
The RDC Onsite Reset Password page requests the username and then sends a new password by email to their registered email address. By default, the link for this page is not enabled. You can enable the link to this page and configure the email functionality. To use the RDC Onsite Reset Password page:
Make sure the following line is not set to a value:
image.ResetPasswordUrl=
Verify that the following value is set as indicated below:
image.ResetPasswordUrlRendered=true
Adjust for an SSL or non-SSL authentication:
If the email server uses SSL authentication, set values as follows:
resetPassword.email.smtp.auth=true
resetPassword.email.smtp.socketFactory.class=javax.net.ssl.SSLSocketFactory
If the email server does not use SSL authentication, set values as below:
resetPassword.email.smtp.auth=false
resetPassword.email.smtp.socketFactory.class=
Set the values for the below parameters:
resetPassword.email.smtp.host: Set to the name of the SMTP host that is set up to send emails.
resetPassword.email.from: Set to the sender name to be displayed on sent emails.
resetPassword.email.username: Set to the email account on the SMTP host that is used to send the email.
resetPassword.email.password: Set to the password for the email account that is sending the email messages. Leave this parameter blank if the password is not required by the server.
resetPassword.email.smtp.port: Set to the port used by the SMTP server. Common values are 465 for SSL-enabled servers, or 25 for non-SSL servers.
You can customize the messages of the SMTP host for password changes. The message parameter and default values are listed below.
resetPassword.email.message.subject: The default text is Reset Password Request for {0}, where {0} is replaced by the username for which the password is reset.
resetPassword.email.message.body: The default text is This message confirms that your password has been reset. The new password for user {0}, database {1} is: {2}, where {0} is replaced by the username for which the password is reset, {1} is replaced by the name of the database, and {2} is replaced by the new password.
resetPassword.error.failed.text: The default text is Failed to reset password. Please contact your help desk.
resetPassword.error.nousername.text: The default text is Please provide a valid username.
resetPassword.error.failedemail.text: The default text is Your Password has been reset, however the e-mail notification failed to launch. Please contact your system administrator.
resetPassword.confirm.text: The default text is Your Password has been reset. Please check your e-mail for the new password.
Save your changes.
Restart the Opaserver.
For details, see Section D.4, "Restarting the OpaServer".
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:
Create an image file of your product branding that has a 155 pixel width and 20 pixel height, or an image of your co-brand logo that has a 100 pixel width and 20 pixel height, or both.
Note:
Any image type is supported for product branding and co-branding.Copy the image files to the <opa_home>\html\images folder. For example, C:\opapps51\html\images.
Open the RdcLogos.properties file in a text editor. You can find the file in the OPA_CONFIG_FOLDER. The folder path is determined by the registry entry opa51, found under HKEY_LOCAL_MACHINE > Software > Oracle.
To replace the product brand in the upper left corner of the RDC pages:
Find the string image.ProductBranding=images/FNDSSCORP.gif.
Replace FNDSSCORP.gif with the name of the file containing the product brand image you placed in the images folder at step 1.
To place a co-brand in the upper right corner of the RDC pages:
Find the string image.CoBranding=images/co_brand.jpg.
Replace co_brand.jpg with the name of the file containing the co-brand image you placed in the images folder at step 1.
Find the string image.CoBrandingRendered=false and replace the value false with true.
Save your changes to the RdcLogos.properties file.
Restart the Opaserver for the changes to take effect.
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 WebLogic Admin Server.
Log in to the RDC Onsite application server.
Navigate to the OPA_CONFIG_FOLDER. The folder path is determined by the registry entry opa51, found under HKEY_LOCAL_MACHINE > Software > Oracle.
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 WebLogic Admin Server 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.
The RdcTexts.properties file is located in OPA_CONFIG_FOLDER. This path comes from the registry entry opa51 under HKEY_LOCAL_MACHINE > Software > Oracle.
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 WebLogic Admin Server.
Log in to the RDC Onsite application server.
Navigate to OPA_CONFIG_FOLDER. Its path comes from the registry entry opa51 under HKEY_LOCAL_MACHINE > Software > Oracle.
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 WebLogic Admin Server.
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 that appears in the same window as the approval. 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:
Make a copy of olsardc.ear from the upload folder or equivalent pat: middleware_home\user_projects\domains\OPADomain\servers\AdminServer\upload\olsardc.ear
Open olsardc.ear using any utility to unzip.
From there traverse to the location of de_external.properties in the following path:
middleware_home\user_projects\domains\OPADomain\servers\AdminServer\upload\olsardc.ear\RdcSurroundAdfWebUIWebApp.war\WEB-INF\lib\rdcdataentry.jar\oracle\pharma\rdc\de\resource\properties\de_external.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.
Click Ok when prompted to replace the modified files in the war and ear.
Close the unzip utility.
You now need to deploy the customization, see Appendix D for details.
To customize the approval warning messages for the application pages:
Stop the WebLogic Admin Server.
Log in to the RDC Onsite application server.
Navigate to OPA_CONFIG_FOLDER. The folder path is determined by the registry entry opa51 under HKEY_LOCAL_MACHINE > Software > Oracle.
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 WebLogic Admin Server instance.
In addition to customizing the approval warning messages, you can:
Disable approval from RDC Onsite. See Section 3.3.4, "Allowing CRF Group Actions" for more information.
Set a timeout value for pre-population of user name for approvals. See Section 8.2, "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 WebLogic Admin Server.
Log in to the RDC Onsite application server.
Navigate to the OPA_CONFIG_FOLDER. The folder path is determined by the registry entry opa51, found under HKEY_LOCAL_MACHINE > Software > Oracle.
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 WebLogic Admin Server 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 WebLogic Admin Server instance.
Log in to the RDC Onsite application server.
Navigate to the OPA_CONFIG_FOLDER. The folder path is determined by the registry entry opa51, found under HKEY_LOCAL_MACHINE > Software > Oracle.
Open the RdcConfig.properties 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.
Save your changes.
Restart the WebLogic Admin Server 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_row_fetched parameter to the RdcConfig.properties 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.
Note:
Increasing the value is likely to degrade performance. Reducing the value may improve performance for any given search, but may require more searches to be executed by the user.To change the maximum number of rows fetched:
Log in to the RDC Onsite application server.
Navigate to the OPA_CONFIG_FOLDER. The path is determined by the registry entry opa51 under HKEY_LOCAL_MACHINE > Software > Oracle.
Open the rdcConfig.properties file with a text editor.
Update the value for max_row_fetched in the file. The default value is 1000.
Save your changes.
Custom pages can be kept in the following folder:
middleware_home>>\user_projects\domains\OPADomain\ user_projects\domains\OPADomain\servers\OpaServer1\tmp\_WL_user\olsardc****\<<DynamicFolderPerDeployment>>\war
For example, the location for the test.pdf file would be:
middleware_home\user_projects\domains\OPADomain\servers\OpaServer1\tmp\_WL_user\olsardc_5.1.0.0.15-b00\pqp2wi\war\test.pdf
The url corresponding to the same test.pdf file used as example is:
<a target="_blank" href="https://XXXXX/rdcadfsrnd/test.pdf">https://XXXXX/rdcadfsrnd/test.pdf</a>
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 11, "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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