IWRS Slot Reservations and Cohort Management User

Transcription

IWRS Slot Reservations and
Cohort Management
User Guide
Version 1, 03-Mar-2014
This User Guide provides instructions on how to process a Slot Reservation and
perform Cohort Management in IWRS.
Technical support at support.ctms@theradex.com
CTMS Help Desk:
609-619-7802
Theradex Main telephone: 609-799-7580
CTMS fax:
609-799-9391
Postal address:
Theradex
CN 5257
Princeton, NJ 08543
Physical address:
Theradex
4365 Route 1 South
Suite 101
Princeton, NJ 08540
IWRS User Guide
Copyright© 2014 by Theradex®, Princeton, N.J.
1
Version Date: 7 Mar 2014
All rights reserved
Table of Contents
OVERVIEW ................................................................................................................................................ 3
1.
Accessing IWRS .................................................................................................................................. 4
2.
Slot Reservations ................................................................................................................................. 5
3.
2.1
Request a Slot Reservation ......................................................................................................... 5
2.2
View Slot Reservation Status ..................................................................................................... 8
2.3
Cancel a Slot Reservation ........................................................................................................... 9
2.4
Approve a Slot Reservation ...................................................................................................... 11
Cohort Management ......................................................................................................................... 13
3.1
Open and Close Cohorts ........................................................................................................... 13
3.2
Change Accrual Limits ............................................................................................................. 15
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OVERVIEW
The intent of this document is to provide instructions on how to process a Slot Reservation and
perform Cohort Management in IWRS.
For multi-site studies, Slot Reservations is a feature used to ensure a slot is available before
speaking with a potential study participant. IWRS can be configured to require Lead Institution
approvals on slot reservations.
Cohort Management provides the Study Administrator a facility for opening and closing cohorts,
and changing accrual limits. As a dose escalation study processes, management of active cohorts
is essential. Email notifications to sites of cohort changes are sent automatically.
At any time, all Cohorts can be set to Not Active, preventing further registrations. For the studies
that are defined as Single-Active cohorts, setting a Cohort to Active will deactivate all other
cohorts.
Changes to Cohorts fields that are not editable by the Study Administrator are managed by
Theradex.
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1.
Accessing IWRS
The following steps describe how to access IWRS.
Step 1
Logon to Open by entering https://open.ctsu.org into your URL. At the Open logon screen, enter your
Username and Password in the provided fields. Click on the I Agree and logon link.
Step 2
At the CITN: Cancer Immunotherapy Trials Network screen, click on the Theradex IWRS Cohort
Management/Slot Reservations link listed under Registration.
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The next screen will be the Welcome to the Interactive Web Response System screen, (IWRS).
2.
Slot Reservations
2.1
Request a Slot Reservation
The following steps describe the process by which users can Reserve Slots.
Step 1
At the Welcome to the Interactive Web Response System screen, to reserve a slot, hover your mouse
over Patients on the navigation bar to get the drop down options.
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Step 2
Click on Reserve a Slot.
Step 3
At the Reserve a Slot screen, click on the Reserve link to reserve a slot for the selected cohort. Only
active cohorts that have open slots available will be eligible for new reservations. A limit is placed on
how many slots a site can reserve at a time.
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Step 4
For registrars responsible for multiple sites, the following screen displays. Use the drop down to select the
appropriate site and click the Reserve link.
For studies that require reservations to be approved, this confirmation is displayed, and will show in the
Slot Reservation list as Pending Approval. A Slot Reservation email is automatically sent to the person
who reserved the slot.
Example of Slot Reservation Approval Request email.
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For Studies that do not require approvals, the slot is now reserved.
2.2
View Slot Reservation Status
Step 1
When viewing a Slot Reservation for a Selected Cohort, click on the magnifying glass for the selected
cohort to view the status of the reservation.
Until approved, the status of the reservation will appear as Pending Approval.
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Once approved, the status of the reservation will change to Reserved.
2.3
Cancel a Slot Reservation
Step 1
To cancel a Slot Reservation, access the Welcome to the Interactive Web Response System screen and
hover your mouse over Patients and click on Reserve a Slot.
Step 2
At the Reserve a Slot screen, click on the magnifying glass for the selected cohort.
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Step 3
The Slot Reservation for the Selected Cohort section will appear at the bottom of the screen. Click on
the X link listed under the Action column.
Step 4
You will be asked to confirm the deletion of the reservation. Click Yes in the pop up to cancel the
reservation.
Or click No to keep the reservation.
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2.4
Approve a Slot Reservation
Step 1
At the Welcome to the Interactive Web Response System screen, hover your mouse over Cohorts and
select Approved a Slot Reservation.
Step 2
To approve the reservation, at the Slot Reservation screen, click the magnifying glass in the View
column to view the slot reservations for that cohort which will be listed at the bottom of the screen. Click
on the Approve link.
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Step 3
At the Approve Slot Reservation pop-up, click on Yes to approve. Click on No to cancel the approval
process without affecting the pending request.
Step 4
To deny the reservation, at the Slot Reservation screen listed in Step 2, click the magnifying glass in the
View column to view the slot reservations for that cohort which will be listed at the bottom of the screen.
Click on Deny.
Enter the reason for denial in the provided field and click on Save to continue. Click on Cancel to cancel
the denial without affecting the pending request.
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3.
Cohort Management
3.1
Open and Close Cohorts
Step 1
To manage cohorts, access the Welcome to the Interactive Web Response System screen and hover
your mouse over Cohorts. Click on Cohort Management.
Step 2
To open and close a cohort, navigate to the selected cohort and click the edit icon listed under the Action
column.
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Step 3
Click the box for the selected cohort in the Active column to open or close a cohort. A checked box
indicates “Open” and an unchecked box indicates “Closed”. When done, click on the green check mark to
exit the edit mode. To cancel changes, click on the X under Action.
Note:
For Studies that are defined as a Single-Active Cohort, setting a cohort to Active will
deactivate all other cohorts.
Step 4
Once you are out of the edit mode, click Save to save your changes.
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IWRS Notification emails will be sent to previously identified personal.
3.2
Change Accrual Limits
Step 1
Click the Edit icon as described in Open and Close Cohorts (Section 3.1). At the Define the Cohort
screen, change the Accrual Limit by entering a value in the accrual limit field for the selected cohort, and
click Save.
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IWRS Slot Reservations and Cohort Management User

Transcription

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