Supporting Blinded and Unblinded Users for Clinical Trials

This chapter describes blinded and unblinded support in Siebel Clinical, how to control access to data for blinded and unblinded users, and how to administer blinded and unblinded users for clinical trials. It includes the following topics:

Note: This feature is available in Siebel CRM 20.7 Update and later releases.

What is a Blinded and Unblinded Clinical Trial?

A blinded clinical trial is one where participants do not know which treatment or medical intervention they have been allocated. In a blind clinical trial, certain information which may influence the participants in the trial (including subjects, CRAs, and evaluators) is withheld or hidden (blinded) until after the trial is complete. Good blinding can reduce or eliminate experimental biases that arise from participant expectation, observer bias, confirmation bias, and so on.

An unblinded clinical trial is one where information is not withheld from trial participants and, in such cases, both participants and researchers know which treatment is being administered. During the course of a clinical trial, a participant becomes unblinded if they obtain information that has been withheld or hidden (blinded) from them. However, if this occurs unintentionally before the end of the trial, then this can be a source of experimental error.

Blinded and Unblinded Support in Siebel Clinical

Siebel Clinical provides the option to have and the ability to manage both blinded and unblinded users for clinical trials in Siebel CRM 20.7 Update and later releases.

Key issues to note about blinded and unblinded support in Siebel Clinical include the following:

All users are blinded by default in Siebel Clinical Trial Management System (CTMS).
- Blinded users can view blinded data.
  
  Blinded users cannot view unblinded data in Site Visits and Activities.
- Unblinded users can view unblinded data.
  
  Unblinded users can either view blinded data in Site Visits and Activities in read-only mode (this is the default behavior) based on a study level preference setting or they cannot view blinded data in Site Visits and Activities at all. The study level preference setting, Hide blinded content for unblinded users, is controlled by the Siebel Clinical administrator – see Controlling Access to Blinded Data for Unblinded Users for more information.
The Siebel Clinical administrator can associate either blinded or unblinded users to the study team at the protocol, region, or site level.
A user can be blinded at some sites and unblinded at others in the same study, and this is controlled by the Siebel Clinical administrator.
Site Visits, Activities, and Document Tracking created by blinded users are blinded.
Site Visits, Activities, and Document Tracking created by unblinded users are unblinded.

Controlling Access to Data for Blinded and Unblinded Users

Access control is the term used to describe the set of Siebel application mechanisms that control user access to data and application functionality. Controlling access to data for blinded and unblinded users involves the following tasks:

Controlling Access to Blinded Data for Unblinded Users

Unblinded users by default see both blinded data and unblinded data, where blinded data is displayed in read-only mode. However, administrators can modify this default behaviour by changing the protocol level setting Hide blinded content for unblinded users.

Access to blinded data by unblinded users is controlled by the protocol level setting Hide blinded content for unblinded users. This setting is deselected (set to N) by default in Siebel Clinical, can be changed only by the Siebel Clinical administrator, and is configured at the protocol level.

To configure access to blinded data for unblinded users

Navigate to the Administration - Clinical screen, then the Protocol List view.
In the Protocol list, drill down on a protocol number field.

Configure the Hide blinded content for unblinded users check box as required as shown in the following table.

Setting (Check box)	Value	Description
Hide blinded content for unblinded users	N (Deselected, default setting)	Indicates that unblinded users can view blinded data, like Site Visits and Activities, in read-only mode. This is the default behaviour.
Hide blinded content for unblinded users	Y (Selected)	Indicates that unblinded users cannot view blinded data, such as Site Visits and Activities.

Setting Blinded and Unblinded User Access at Protocol Level

The following procedure shows how administrators configure blinded or unblinded user access for protocol team members.

To set blinded or unblinded user access at protocol level

Navigate to the Administration - Clinical screen, then the Protocol List view.
In the Protocol list, drill down on the protocol (number field) for which you want to configure the blinded or unblinded user access.
Click the multiple select button in the Team field.

A multiple selection dialog box appears showing a list of the available and selected protocol team members (users).

For each user in the Selected list that should have unblinded protocol level access, configure the Unblinded field as shown in the following table.

Field	Value	Description
Unblinded	N or Null (Deselected, default setting)	Deselect this option to make the user blinded. All users are blinded by default.
Unblinded	Y (Selected)	Select this option to make the user unblinded. Unblinded users are highlighted in the color red.

Click OK when prompted to confirm the update in the Unblinded field.
If required at protocol level, click Position Rolldown to roll down the changes to all the regions and sites for the protocol. The position roll down hierarchy goes from Protocol, to Region, and then to Site level.

Setting Blinded and Unblinded User Access at Region Level

All users within a region will inherit the same blinded or unblinded user access that they have at the protocol level provided the position was rolled down from the protocol team to the site level. For newly created regions, administrators can either:

Go back to the required protocol and click Position Rolldown to roll down the protocol team user access to the region level.
Directly configure blinded or unblinded user access for region team members as shown in the following procedure.

To set blinded or unblinded user access at region level

Navigate to the Administration - Clinical screen, then the Region List view.
In the Region list, drill down on the region for which you want to configure the blinded or unblinded user access.
Click the multiple select button in the Team field.

A multiple selection dialog box appears showing a list of the available and selected region team members (users).

For each user in the Selected list that should have unblinded region level access, configure the Unblinded field as shown in the following table.

Field	Value	Description
Unblinded	N or Null (Deselected, default setting)	Deselect this option to make the user blinded. All users are blinded by default.
Unblinded	Y (Selected)	Select this option to make the user unblinded. Unblinded users are highlighted in the color red.

Click OK when prompted to confirm the update in the Unblinded field.
If required at region level, click Position Rolldown to roll down the changes to all the sites for the region. The position roll down hierarchy goes from Protocol, to Region, and then to Site level.

Setting Blinded and Unblinded User Access at Site Level

All users within a site will inherit the same blinded and unblinded user access that they have at the protocol or region level provided the position was rolled down from the protocol or region team to the site level. For newly created sites, administrators can either:

Go back to the required protocol or region and click Position Rolldown to roll down the protocol or region team user access to the site level.
Directly configure blinded and unblinded user access for site users as shown in the following procedure.

Precedence is given to configuration of blinded and unblinded user access at site level. If the blinded and unblinded user access is updated at site level, then position roll down from protocol and/or region cannot override the definition at site level, since site has more precedence.

To set blinded and unblinded user access at site level

Navigate to the Administration - Clinical screen, then the Site List view.
In the Site list, drill down on the site for which you want to configure the blinded and unblinded user access.
Click the multiple select button in the Team field.

A multiple selection dialog box appears showing a list of the available and selected site team members (users).

For each user in the Selected list that should have unblinded site level access, configure the Unblinded field as shown in the following table.

Field	Value	Description
Unblinded	N or Null (Deselected, default setting)	Deselect this option to make the user blinded. All users are blinded by default.
Unblinded	Y (Selected)	Select this option to make the user unblinded. Unblinded users are highlighted in the color red.

Click OK when prompted to confirm the update in the Unblinded field.
If required at site level, click Position Rollup to update the Unblinded field for users at protocol and region levels. The position roll up hierarchy goes from Site, to Region, and then to Protocol level.

Setting Access to Unblinded Activities in Core Activities View and Contact Activities View

All users are blinded by default in Siebel Clinical, which means that users can typically see only unblinded activities. However, if a user is assigned the Unblinded Activity Responsibility (a responsibility assigned to Siebel Clinical administrators by default), then that user will have access to unblinded activities in Siebel Clinical core Activities view and Contact Activities view.

To set access to unblinded activities in core Activities View and Contact Activities views

Log in to Siebel Tools.
Go to Business Component and query for the name Action.
Go to the Business Component User Properties for the Action business component.
Query for the name Unblinded Activity Responsibility.
Update the Value field for Unblinded Activity Responsibility by adding the required user roles (or responsibilities) to it.

These user roles will be able to view unblinded data in Siebel Clinical core Activities and Contact Activities views. Siebel Administrator is mapped by default to the Unblinded Activity Responsibility business component user property.

Site Management for Blinded and Unblinded Users

Site management for blinded and unblinded users involves the following:

Identifying Type of User Access at Protocol Site

A user can be blinded at one site and unblinded at another site in the same study. The User indication bar in the form toolbar of a selected site helps users identify the type of user access they have to a site.

To identify type of user access at protocol site

Navigate to the Site Management screen, then the Protocol Site list view.
In the Protocol Site list view, drill down on a site.
Review the User indication bar in the form toolbar of the selected site as follows:
- A red User indication bar, labelled Blinded when you hover over it, indicates that the user access to the site is blinded.
- A green User indication bar, labelled Unblinded when you hover over it, indicates that the user access to the site is unblinded.

Document Tracking for Sites

You administer document tracking for sites by navigating to the Site Management screen, Protocol Site list view, drilling down on a Site, and then navigating to the Document Tracking view.

From the Document Tracking view for a site, you can create new document tracking records. Note the following about document tracking for sites for blinded and unblinded users:

Document tracking records created by unblinded users are unblinded. In this case, the Unblinded field for each unblinded record is selected (Unblinded=Y) and the record is highlighted in the color red.
Document tracking records created by blinded users are blinded. In this case, the Unblinded field for each blinded record is deselected (Unblinded=N or Null).
Unblinded users can either view blinded document tracking records in read-only mode (depending on the protocol level setting Hide blinded content for unblinded users) or cannot view blinded document tracking records at all.
Blinded users cannot view unblinded document tracking records.

Managing Site Activities for Blinded and Unblinded Users

You manage activities for a site by navigating to the Site Management screen, Protocol Site list view, drilling down on a Site, and then navigating to the Activities view.

From the Activities view for a site, you can create new site activities. Note the following about managing site activities for blinded and unblinded users:

Activities created by unblinded users are unblinded. In this case, the Unblinded field for each unblinded activity record is selected (Unblinded=Y) and the activity is highlighted in the color red.
Activities created by blinded users are blinded. In this case, the Unblinded field for each blinded activity record is deselected (Unblinded=N or Null).
Unblinded users can either view blinded activites in read-only mode (depending on the protocol level setting Hide blinded content for unblinded users) or cannot view blinded activities at all.
Blinded users cannot view unblinded activities.
Blinded users cannot be added as an employee to an unblinded site activity.

Managing Site Activity Plans for Blinded and Unblinded Users

You manage activity plans for a site by navigating to the Site Management screen, Protocol Site list view, drilling down on a Site, and then navigating to the Activity Plans view.

From the Activity Plans view for a site, you can create new activity plans. Note the following about managing activity plans for blinded and unblinded users:

Activity Plans created by unblinded users are unblinded. In this case, the Unblinded field for each unblinded activity plan is selected (Unblinded=Y) and the activity is highlighted in the color red.
Activity Plans created by blinded users are blinded. In this case, the Unblinded field for each blinded activity plan is deselected (Unblinded=N or Null).
All Activities associated with unblinded activity plans are unblinded.
All Activities associated with blinded activity plans are blinded.
Unblinded users can either view blinded activity plans in read-only mode (depending on the protocol level setting Hide blinded content for unblinded users) or cannot view blinded activity plans at all.
Blinded users cannot view unblinded Activity Plans and the associated unblinded activities.

Managing Site Visits for Blinded and Unblinded Users

You manage site visits by navigating to the Site Management screen, Protocol Site list view, drilling down on a Site, and then navigating to the Site Visits view.

From the Site Visits view, you can create new site visits. Note the following about managing site visits for blinded and unblinded users:

Site Visits created by unblinded users are unblinded. In this case, the Unblinded field for each unblinded site visit is selected (Unblinded=Y) and the site visit is highlighted in the color red.
Site Visits created by blinded users are blinded. In this case, the Unblinded field for each blinded site visit is deselected (Unblinded=N or Null).
Unblinded users can either view blinded site visits in read-only mode (depending on the protocol level setting Hide blinded content for unblinded users) or cannot view blinded site visits at all.
Blinded users cannot view unblinded Site visits and they:
- Cannot be assigned to an unblinded Site Visit.
- Cannot be assigned to Checklist Activities, Follow-up items or All follow-up activities of an unblinded trip report.
When the protocol level setting Hide blinded content for unblinded users is not selected and an unblinded user has read-only access to blinded site visits, then the following conditions are true:
- Trip report Checklist Activities are read-only.
- Trip report Follow Up Activities are read-only.
- Unblinded trip reports will show only unblinded records in the All follow Up Activities view.
- Trip report Case Report Form Tracking is read-only.
- The New File and New URL options in Site Visit Attachment is disabled.
If the protocol level setting Hide blinded content for unblinded users is selected, then for unblinded users, unblinded trip reports will show only unblinded records in the All Follow Up Activities view.
All versions of a blinded site visit will remain blinded, and all versions of an unblinded site visit will remain unblinded.

Managing All Site Visits for Blinded and Unblinded Users

You manage All Site Visits by navigating to the Administration - Clinical screen, then the Site Visits view.

This read-only view has a consolidated list of all site visits in the system, including blinded and unblinded site visits.

Managing Site BIP Reposts for Blinded and Unblinded Users

My BIP Reports shows all reports for reportees irrespective of user access (that is, whether users are blinded or unblinded). The My BIP Reports view does not apply for blinded users who have unblinded reportees. To ensure that blinded users who have unblinded reportees will not be able to see unblinded data, it is recommended that those blinded users should not be provided access to reoprts.

Managing Activities for Blinded and Unblinded Users

You manage activities by navigating to the Activities screen, then the All Activities view.

From the All Activities view, you can create new activities. Note the following about managing activities for blinded and unblinded users:

By default, all users see only blinded activities in the All Activities view under Activities.
Activities created directly in the All Activities view under Activities are blinded.

Note: Unblinded activities are created in the Activities view under a site (not in the All Activities view under Activities), for more information, see Managing Site Activities for Blinded and Unblinded Users.
Users who are assigned the responsibility Unblinded Activity Responsibility can see both blinded and unblinded records in the All Activities view.
- Siebel Clinical administrators are assigned the Unblinded Activity Responsibility by default.
- To associate other user roles with the Unblinded Activity Responsibility, see Setting Access to Unblinded Activities in Core Activities View and Contact Activities View

Managing Contact Activities for Blinded and Unblinded Users

You manage contact activities by navigating to the Contacts screen, then the All Contacts view, drilling down on the Last Name of a contact, and then navigating to the Activities view.

From the Contact Activities view, you can create new contact activities. Note the following about managing contact activities for blinded and unblinded users:

By default, all users see only blinded activities in the Activities view under Contacts.
Activities created directly in the Activities view under Contacts are blinded.

Note: Unblinded activities are created in the Activities view under a site (not in the Activities view under Contacts), for more information, see Managing Site Activities for Blinded and Unblinded Users.
Users who are assigned the responsibility Unblinded Activity Responsibility can see both blinded and unblinded records in the Contact Activities view.
- Siebel Clinical administrators are assigned the Unblinded Activity Responsibility by default.
- To associate other user roles with the Unblinded Activity Responsibility, see Setting Access to Unblinded Activities in Core Activities View and Contact Activities View

Inheritance Hierarchy for Blinded and Unblinded Users

This topic describes the inheritance hierarchy for blinded and unblinded users.

Sites, Regions, and Protocols are never blinded or unblinded in Siebel Clinical. It is the users at the different (site, region, or protocol) levels that are either blinded or unblinded. For example, if a user is blinded at site and protocol level but unblinded at the region level, then that user will automatically have blinded access for all site level work like site visits and activities. However, rolling up or down the configuration will change the type of user access accordingly - see the following tables for more information.

Precedence is given to configuration of the Unblinded field for users at site level. If the Unblinded field for a user is updated at site level, then position roll down from protocol and/or region cannot override the Unblinded field definition at site level, since site has more precedence.

Position Rollup

The position roll up hierarchy goes from Site, to Region, and then to Protocol level.

When you click Position Rollup at site level, all changes (in the Unblinded field for users at site level) will be rolled up to the region and protocol levels.
When you click Position Rollup at region level, all changes (in the Unblinded field for users at region level) will be rolled up to the protocol level.

The following table shows a user's Unblinded field value after performing a Position Rollup.

Level	User's Unblinded Field Value	Position Rollup?	Unblinded Field Value After Position Rollup
Site	Blinded	Yes, to Region and Protocol levels.	Not Applicable
Region	Unblinded	Yes, to Protocol level.	Blinded
Protocol	Blinded	Not Applicable.	Unblinded if Position Rollup is performed from region level, otherwise Blinded.

Position Rolldown

The position roll down hierarchy goes from Protocol, to Region, and then to Site level.

When you click Position Rolldown at protocol level, all changes will be rolled down to all the regions and sites for the protocol.
When you click Position Rolldown at region level, all changes will be rolled down to all the sites for the region.

The following table shows a user's Unblinded field value after performing a Position Rolldown.

Level	User's Unblinded Field Value	Position Rolldown?	Unblinded Field Value After Position Rolldown
Protocol	Blinded	Yes, to Region and Site levels for the selected protocol.	Not Applicable
Region	Unblinded	Yes, to Site level for the selected region.	Blinded
Site	Blinded	Not Applicable.	Blinded Note: If Position Rolldown is performed at Region level, it does not apply since precedence is always given to the value at site level.

Blinded and Unblinded Support in Siebel Mobile Disconnected Applications

In Siebel Mobile disconnected applications:

Blinded users can view and access blinded site visits.
Unblinded site visits are not available.
Unblinded users can view blinded records in read-only mode irrespective of the protocol level setting Hide blinded content for unblinded users.

Blinded and Unblinded Customization Support

You can add new custom child applets under Site and Site visits and, if required, enable the blinding or unblinding functionality for those applets as follows:

For the business component in question, create a new Enable Unblinding user property with the value Y.
If your business component is based on the Event Activity table, then use the CSSBCClinicalGenericActivity class for your business component. Otherwise use the CSSBCClinicalGenericBusComp class for your business component.
List Applet must use the following class: CSSSWEClinicalListBase.
Form Applet must use the following class: CSSSWEClinicalFormBase.
The Business Component field must contain the following field defined on column: UNBLINDED_FLG.