Phase Forward IRT - soramic.com · IRT Project Manager. Pharmtrace. ... You have been provided...
52
Copyright © 2009 Phase Forward Incorporated. All rights reserved. Interactive Response Technology (IRT) User Training 27 August 2010 Elke Dooms– IRT Project Manager Pharmtrace SORAMIC Phase Forward IRT
Transcript of Phase Forward IRT - soramic.com · IRT Project Manager. Pharmtrace. ... You have been provided...
Copyright ©
2009 Phase Forward Incorporated. All rights reserved.
Interactive Response Technology (IRT) User Training27 August 2010Elke Dooms–
IRT Project Manager
PharmtraceSORAMIC
Phase Forward IRT
………………………………………………………………………………………………………..……………………………………...InterActive Response Technology
Database
which uses a touch-tone
telephone or web interface for data entries
IRT Support available for assistance
2
IRT Support
System User
Database
IRT= InterActive Response Technology
Overview•
IRT Visit Schedule
•
IRT Access:– User ID Cards
– User Authentication Code
– Phone and Web Access
– First-time Login process
– Important Notes
•
IRT Functions– Navigation
– Home Tab
– Subjects Tab
– Supplies Tab
•
IRT Support
3
IRT Visit Schedule
4
IRT Visit Schedule
5
IRT expected visit Visit window (Soft) Kits assigned (only if Local Ablation arm)
Visit Day Min. Max. Screening N/A N/A N/A N/A
Randomization 31 -24 +25 2
Follow Up 61 -14 +14 0, 1 or 2
Follow Up 122 -14 +14 0, 1 or 2
Follow Up 183 -14 +14 0, 1 or 2
Follow Up 244 -14 +14 0, 1 or 2
Follow Up 305 -14 +14 0, 1 or 2
Follow Up 366 -14 +14 0, 1 or 2
Follow Up 427 -14 +14 0, 1 or 2
Follow Up 488 -14 +14 0, 1 or 2
Follow Up 549 -14 +14 0, 1 or 2
Follow Up 610 -14 +14 0, 1 or 2
Follow Up 671 -14 +14 0, 1 or 2
Follow Up 732 -14 +14 0, 1 or 2
Follow Up 793 -14 +14 0, 1 or 2
Follow Up 854 -14 +14 0, 1 or 2
Randomization is registered for both the Local Ablation Arm and the Palliative ArmFollow Up visits are only registered for the Local Ablation Arm
IRT Visit Schedule
6
IRT expected visit Visit window (Soft) Kits assigned (only if Local Ablation arm)
Visit Day Min. Max. Follow Up 915 -14 +14 0, 1 or 2
Follow Up 976 -14 +14 0, 1 or 2
Follow Up 1037 -14 +14 0, 1 or 2
Follow Up 1098 -14 +14 0, 1 or 2
Follow Up 1159 -14 +14 0, 1 or 2
Follow Up 1220 -14 +14 0, 1 or 2
Follow Up 1281 -14 +14 0, 1 or 2
Follow Up 1342 -14 +14 0, 1 or 2
Follow Up 1403 -14 +14 0, 1 or 2
Follow Up 1464 -14 +14 0, 1 or 2
Follow Up 1525 -14 +14 0, 1 or 2
Follow Up 1586 -14 +14 0, 1 or 2
Follow Up 1647 -14 +14 0, 1 or 2
Follow Up 1708 -14 +14 0, 1 or 2
Follow Up 1769 -14 +14 0, 1 or 2
Follow Up 1830 -14 +14 0, 1 or 2
Follow Up visits are only registered for the Local Ablation Arm
IRT Access
7
IVRS/ IWRS User Access InformationSponsor: PharmtraceProtocol: SORAMIC
User Access ID: 123456
Confidential: Please contact IRT Support if the seal is broken
User ID Cards
The User ID Card is a sealed
envelope
It contains your User ID and Default Password
The User ID Card will be sent to you via courier or handed out by your CRA
8
IRT AccessUser ID Cards
User IDs are your User IDs are your electronic electronic
signature and signature and MUST NOTMUST NOT be be
sharedshared
Dear System User: You have been provided access to the Phase Forward web-integrated Interactive Voice Response System for your study protocol. Please follow instructions on the use of your User ID as described in the designated manual. If the seal on this envelope has been broken, please contact IRT Support:
1-877-IVRS-HLP (US only) Country specific IVRS access number and press ‘0’ Email at [email protected].
This User ID provides access to highly confidential information. Please do not share this material with anyone and always store it in a safe location.
In the event that your password requires re-setting, please keep the information below with your User ID and password so the password can be reset to the default provided.
Protocol: SORAMIC
User ID: 123456
Study Code: 478 Default Password: 12345
IVRS Phone Number: Phase Forward IVRS Access Number or 1-877-725-2749 (US Toll Free)
Phase Forward Website: https://irt.webcrf.net
Phase Forward 24/7 Technical Support:Phase Forward IVRS Access Number (Toll free) and dial ‘0’ for support 1-877-IVRS-HLP (Toll Free) [email protected]
IVRS/ IWRS USER ACCESS INFORMATION
Sponsor: Pharmtrace Protocol: SORAMIC
User Access ID: 12345
CONFIDENTIAL: Please contact IRT Support if the seal is broken
IRT System User Authentication Form
User Name: First, Middle, Last (e.g., John T. Doe) Role: Role (e.g., Study Coordinator, Investigator)
Protocol: Pharmtrace SORAMIC ------------------------------------------------------------------------------------------------------------------------------------------------------- Please complete this form and sign below prior to registering your access in the IVR/IWR system.
Please write the User Access ID found on your user envelope:
Please refer to this User Authentication Code when registering your User ID for the first time: # # # # # # # #
Upon the initial login using this User Access ID, you will be required to know the following to enter: Study Code (phone only) User Access ID User Authentication Code You will also need to know one of the following, if applicable: Site ID Depot ID
-------------------------------------------------------------------------------------------------------------------------------------------------------
By signing below, I acknowledge that my electronic user ID and password combination act as my user authentication when gaining access to the IVR system. I also acknowledge I am responsible for keeping my ID and password confidential, and that I will not share my user ID or password with anyone. If I suspect that my user ID or password has been compromised or has been revealed to others, I will contact Technical Support to report this immediately.
User Signature Date
A COMPLETED FORM MUST BE RETAINED AS PART OF THE STUDY RECORDS
IRT Access
The USER ACTIVATION CODE (UAC) will arrive via email
or fax
The UAC is required for your first-time login
Retain this form for the duration of the study
Contact CRA or IRT Support to get a new
UAC
9
User Authentication Code
IRT Access
Go to URL https://irt.webcrf.net/
Type your 6-digit
user id in the User ID field
Type your 5-digit
password in the Password field
Click Enter
10
Web Access
Dial•
Country-specific toll free numbers will be provided
Enter•
Study Code: 478
•
Language Code: 2-digit number (see next slide)
•
User ID: 6-digit number
•
Password: 5-digit number
Welcome Message•
“Welcome to the Pharmtrace Interactive Voice Response System for Protocol SORAMIC.”
IRT AccessPhone Access
IRT AccessAvailable Languages (Phone only!)
01 English
02 French
05 German
06 Italian
09 Spanish
13 Croatian
16 Dutch
24 Polish
27 Serbian
34 Turkish
IRT Access
Create new
confidential password
Create 4-digit PIN
(for password
reset purposes)
Enter User Authentication Code (UAC)•
Contact your CRA if you did not receive a UAC
•
Once UAC is input, the User ID is associated with your name
Enter 4-digit Site Number
13
First-time Login (Web/Phone) –
Account Activation
IRT Access
Login
At any time you may choose to enter the system via phone OR web.
Though,
some of the functions are only available via the web.
Logout
Web
–
always logout of the system by using the “Logout”
button in the top
right of the menu
Web
–
The system will automatically log out if the system has been idle for
more than 5 minutes.
Passwords
Numeric and 5-digits long
Will expire every 180 days
Should be kept secure and secret
14
Important Notes
IRT Functions
15
Home page
You will be directed to the home page after successful login
IRT Functions
16
There are different tabs available in the Title bar
Each tab has a related set of options in the left-hand Navigation pane
Navigation
The tab and function you are using are highlighted in yellow
IRT Functions -
Home
You will have access to the following functions via the Home tab:•
Contact Information
•
Notifications
•
Instructions
17
IRT Functions -
Home
Use this function to update your contact details
Click on ‘Contact Information’
The page will display a form on which you can correct your contact details as required
Click Submit
to save the updates
18
Contact Information (Web Only)
IRT Functions -
Home
19
Contact Information (Web Only)
IRT Functions -
Home
Use this function to re-transmit a confirmation notification or alert
Click on ‘Notifications’
You are able to view and/or re-transmit the notification/alert
Notifications can be re-transmitted to yourself or to other recipients
20
Notifications (Web Only)
IRT Functions -
Home
21
Notifications (Web Only)
The system will ask you to enter the following:•
Select the Retransmission Type:– By Notification Number:
•
Enter the notification number– By Subject Number:
•
Select the Subject number
•
Select the required notification– By Notification Type:
•
Select the notification type
•
Select the required notification
The system will display the notification on the screen for review
Select the recipient to which you want to send the notification
Click ‘Retransmit’
IRT Functions -
Home
22
Notifications (Web Only)
IRT Functions -
Home
You will find links to the following documents•
Toll-free Access Numbers
•
User Manual
23
Instructions (Web Only)
IRT Functions -
Subjects
You perform the following functions in the Subject Tab:•
Screening
•
Screen Failure (also available via Phone)
•
Randomization (also available via Phone)
•
Scheduled Visit (also available via Phone)
•
Unscheduled Visit (also available via Phone)
•
Drug Replacement (also available via Phone)
•
Early Termination (also available via Phone)
•
Completion (also available via Phone)
•
Unblind Treatment (also available via Phone –
Investigators Only!)
•
Edit Subject Data
24
IRT Functions -
Subjects
The page will show a table with the following information for all subjects:•
Subject number, demographics and current subject status
•
Last transaction completed in IRT
•
Next expected visit and expected visit date
Click on the V
symbol to expand the details for a subject
25
IRT Functions -
Subjects
Click on the ‘Screening’
button to Screen a new Subject
26
Screening
IRT Functions -
Subjects
User enters:•
Date of birth
•
Screening Date
CONFIDENTIAL AND PROPRIETARY INFORMATION – NOT FOR DISTRIBUTION
27
IRT output:•
7-digit Subject Number
•
Confirmation of transaction
•
Written notification
Screening
IRT Functions -
Subjects
Select the Subject that you want to Screen Fail
Click on the ‘Screen Fail’
button
28
Screen Failure
IRT Functions -
Subjects
User enters:•
Confirm Age
•
Reason for Screen Fail
•
Date of Screen Fail
CONFIDENTIAL AND PROPRIETARY INFORMATION – NOT FOR DISTRIBUTION
29
IRT output:•
Confirmation of transaction
•
Written notification
Screen Failure
IRT Functions -
Subjects
Select the Subject that you want to Randomize
Click on the ‘Randomize’
button or on ‘Perform Transaction’
30
Randomization
IRT Functions -
Subjects
User enters:•
Confirm Age
•
Select Treatment Group Local Ablation or Palliative Treatment
•
Stratum Local Ablation: # of RFA sessions (1, 2 or 3)
Palliative Treatment: Portal Vein Thrombosis (Y/N)
CONFIDENTIAL AND PROPRIETARY INFORMATION – NOT FOR DISTRIBUTION
31
IRT output:•
Randomization Number
•
If Local Ablation: Bottle Number
•
If Palliative Treatment: Treatment Arm
•
Confirmation of transaction
•
Written notification
Randomization
IRT Functions -
Subjects
Select the Subject for which you need to register the Follow Up Visit
Click on the ‘Scheduled Visit’
button or on ‘Perform Transaction’
32
Scheduled Visit
Scheduled Visits only need to be performed for Subjects in the Local Ablation arm
IRT Functions -
Subjects
User enters:•
Confirm Age
•
Confirm Visit
•
Confirm if Drug is needed– Confirm amount of bottles needed
CONFIDENTIAL AND PROPRIETARY INFORMATION – NOT FOR DISTRIBUTION
33
IRT output:•
If applicable: Bottle Number(s)
•
Confirmation of transaction
•
Written notification
Scheduled Visit
IRT Functions -
Subjects
Select the Subject for which you need to perform an Unscheduled Visit
Click on the ‘Unscheduled Visit’
button
34
Unscheduled Visit
Unscheduled Visits can only be performed for Subjects in the Local Ablation arm
IRT Functions -
Subjects
User enters:•
Confirm Age
•
Confirm Visit
•
Confirm amount of bottles needed
CONFIDENTIAL AND PROPRIETARY INFORMATION – NOT FOR DISTRIBUTION
35
IRT output:•
Bottle Number(s)
•
Confirmation of transaction
•
Written notification
Unscheduled Visit
IRT Functions -
Subjects
Select the Subject for which you need a drug replacement
Click on the ‘Drug Replacement’
button
36
Drug Replacement
Drug Replacements can only be performed for Subjects in the Local Ablation arm
IRT Functions -
Subjects
User enters:•
Confirm Age
•
Select Bottle Number to Replace
•
Select new Bottle Status (damaged/missing)
•
Replace another Bottle?
CONFIDENTIAL AND PROPRIETARY INFORMATION – NOT FOR DISTRIBUTION
37
IRT output:•
Bottle Number(s)
•
Confirmation of transaction
•
Written notification
Drug Replacement
IRT Functions -
Subjects
Select the Subject that you want to Terminate
Click on the ‘Early Terminate’
button
38
Early Termination
IRT Functions -
Subjects
39
Early Termination
User enters:•
Confirm Age
•
Reason for Early Termination
•
Early Termination Date
IRT output:•
Confirmation of transaction
•
Written notification
IRT Functions -
Subjects
Select the Subject that you want to Complete
Click on the ‘Completion’
button or on ‘Perform Transaction’
40
Completion
IRT Functions -
Subjects
41
Completion
User enters:•
Confirm Age
•
Completion Date
IRT output:•
Confirmation of transaction
•
Written notification
IRT Functions -
Subjects
Select the Subject that you want to Unblind
Click on the ‘Unblind Treatment’
button
42
Unblinding (Investigators ONLY!)
IRT Functions -
Subjects
43
Unblinding (Investigators ONLY!)
User enters:•
Confirm you want to Continue
•
Confirm Age
•
Confirm you want to Continue
•
Enter your Password
IRT output:•
Treatment Arm
•
Confirmation of transaction
•
Written notification
IRT Functions -
Subjects
Select the Subject that you want to Edit
Click on the ‘Edit Subject Data’
button
44
Edit Subject Data (Web Only)
You will be able to update the following data:•
Date and Reason of Screen Failure (including deletion of the Screen Failure)
•
Date and Reason Early Termination (including deletion of the Termination)
•
Date Completion (including deletion of the Completion)
NOTE: a reason must
be entered for any modification
IRT Functions -
Supplies
You perform the following functions in the SuppliesTab:•
Register Drug Order Receipt (Order Transactions)
•
Update Center Inventory
45
IRT Functions -
Supplies
The page will show a table with the following information for all drug orders:•
Drug Order #, Destination, Ordered, Days Outstanding, Shipped, Received, Cancelled
Click on the V
symbol to expand the details for a Drug Order
46
Select the Drug Order that you want to register as received
Click on the ‘Register Drug Order Receipt’
button
47
IRT Functions -
SuppliesRegister Drug Order Receipt
48
User enters:•
All arrived complete and undamaged?
•
Entire order damaged?
•
Entire order missing?
•
Enter missing/damaged Bottle Number
•
Status of Bottle Number (damaged/missing)
•
Another Bottle?
IRT output:•
Confirmation of transaction
•
Written notification
IRT Functions -
SuppliesRegister Drug Order Receipt
Click on Update Center Inventory on the left hand side of the screen
49
IRT Functions -
SuppliesUpdate Center Inventory
50
User enters:•
Select either entire inventory or enter individual Bottle Numbers
•
New status (missing/damaged)
•
Another Bottle?
IRT output:•
Confirmation of transaction
•
Written notification
IRT Functions -
SuppliesUpdate Center Inventory
IRT Support
Online User Guide:•
Click on the Question mark symbol in the upper right corner of the screen
•
The User Guide will be opened in a new screen
User Manual:•
In the Home Tab you can download the User Manual
Phase Forward IRT Support
Dial •
Local Toll-Free Number and press 0 to be transferred to IRT support
•
Direct Toll Number: +1-877-859-2991
Email•
IRT Support
52
Available 24/7
