Overview	Top

A Study Suite consists of multiple Stability Studies called "Members". You can work with the Member Studies from within the Study Suite. The statuses of all individual Member Studies are rolled-up to indicate a status for the Study Suite. An individual Member Study can belong to only one Study Suite.

Study Suites are useful for dealing with:

• Studies sharing common tests and timepoints/conditions.
• Studies having different Products, but managed together.
• Studies that do not require approval (Sytudies created within Study Suites need not go through the approval process).
• Single Protocols used for all Studies created within a Study Suite.
• Studies within a single department/owner (thay are viewed together).

Study Suite Status	Top

Study Suite Flow Diagram

This is how the status of a Study affects the status of its Study Suite:

Study Suite Evolution	Top

A Study Suite evolves through these phases. A separate List Page displays Study Suites in each phase:

Creating a Study Suite Request	Top

To create a Study Suite Request navigate to LIMS → Studies → Suite Request. The Study Suite Request List page displays.

Click "New Request" to open the Create new Study Suite dialog.

Choose how the Study Suite will be created:

The Study Suite form (below) is where you specify Study Suite management details.

In the Member Studies tab add Studies with a common purpose to the Suite.

Studies are added to the Suite in two ways:

Associating Approvals with Study Suites	Top

Approval is associated to the Study Suite request for review and approval.

"Add Type" button opens the "Select ApprovalType" lookup page where you can an approval type.

Define Approval properties:

If you need to add another approval step for the selected type, click on the "Add Step" button.

This replicates the selected step.

Approving Study Suite Requests	Top

Submitting for Approval

From the Study Suite list page select the Suite you want to send for Approval and click "Edit". You can also submit a Suite for Approval while creating new request. The Edit Study Suite page displays. Make changes as required prior to Study Suite Approval.

when the information on the Study Suite is correct and needs no further modification click "Submit For Approval". The Study Suite displays on the "Study Suite Approval List" page with the status as "Pending Approval".

Once sent for Approval you can Approve or reject a Study Suite request from the Study Suite Approval List Page, which shows all Study Suite with the status as "Pending Approval". The list page is accessed through the menu option "Suites For Approval".

To approve or reject Study Suite, click "Review" button.

The View Study Suite page is displayed. To approve or reject, click on the "Approve/Reject" button.

The approve/reject page gets displayed on a new window.

The page shows the status of the approval steps specific for the current user.

Here you pass or fail the approval step and enter comment about the approval step.

Multiple steps appear if the user is authorized to approve them all.

The Study Suite has any of the following status.

• Not Started- When all the approval steps are passed.
• Rejected - When any/all the approval steps are failed.

Working with Active Study Suites	Top

To make the Study Suite active select a Suite with the status as "Not Started" from the Study Suite Active List page and click "Edit". 

The Edit Study Suite page displays,

As the status of the member Studies changes, the status of the Study Suite also changes. 

Changing the Status of any Study affects the Study Suite in accordance with the Status Rules. All status changes on an Active Study Suite require approval.

Checking Start activates the Study, with consequences for the Study Suite defined by the Status Rules.

Checking Suspend suspends the Study, with consequences for the Study Suite defined by the Status Rules.

You can restart the Study by editing it and choosing Resume. This again makes the status of the Study and the Study Suite Active.

Checking Complete declares the Study as having been completed, with consequences for the Study Suite defined by the Status Rules.

Checking Cancelled cancels the Study, affecting the Study Suite according to the Status Rules.

Historical Study Suites	Top

The Study Suite Historical List page shows Study Suites that have been cancelled, as well as those that have been declared complete.

However, Suites from Historical Suite list page can be restarted.