1. Randomization and Trial Supply Management using IVRS/IWRS Lundbeck 12402A & 12649A

2. Agenda What is IVRS/IWRS? How it works to manage your medication
Functionalities & User Responsibilities
Single User Log-On
Accessing IVR
Accessing IWR
Getting help and advice
Demonstration

3. What is IVRS/IWRS? What is IVRS/IWRS? Why Do we Use it?
Interactive Voice Response System/ Interactive Web Response System
Touch tone technology and interactive web based technology
User responds to instructions using keypad/keyboard
Direct interaction with global database
Why Do we Use it?
Assists in maintaining Randomization balance
Ensures medication stocks are maintained at sites

4. Medication Management

5. IVRS/IWRS Functionalities & User Responsibilities

6. Call Options Investigators and Study Coordinators: Medication Arrival
Register medication as having arrived at the site within correct temperature range, and register any medication as missing or damaged.
Damaged Medication
Register previously arrived medication as missing or damaged

7. Call Options Investigators only: Randomisation
Randomise an eligible patient into the study
Emergency Re-Supply
Re-supply a patient with additional blinded medication
Site Code Break
Code break a patient to reveal the treatment group assigned at randomisation

8. Medication Arrival and Damaged Medication
Available for both investigators and Study Coordinators
Enter:
Consignment number (for Medication Arrival)
Answer the question on the temperature range
Damaged medication number
Outcome:
Registers the arrival of a consignment of medication at the site
The IMP will be released or quarantined depending on the temperature
Damaged/missing medication will be replaced
In case IMP is quarantined Lundbeck will check the deviation and if IMP is acceptable to use the site will receive a ‘Medication Release Confirmation’. If not acceptable the site will receive new IMP.

9. Randomization Enter: Outcome: Screening number Subject’s Date Of Birth
Subject’s NIHSS Score
Date of Stroke Onset
Time of Stroke Onset (24 hour clock format)
Subject’s weight (in Kilograms)
4 digit PIN
Outcome:
Patient is Randomized
Pack number dispensed
Dose to administer is calculated

10. Emergency Re-Supply Enter: Outcome: Screening number
Subject’s Date of Birth (for verification)
4 digit PIN
Outcome:
Patient is re-supplied
New Pack number to dispense

11. Emergency Code Break Enter: Outcome: Screening number
Confirm medically necessary to break the Randomization code
4-digit PIN
Outcome:
ClinPhone will read out the patients Randomized treatment group
Lundbeck will be notified immediately following the call and the patient will automatically be withdrawn from the trial.

12. Reporting Real time notifications Alerts
Faxed/ ed following each call
File with other study related documentation
Lists all entries and all responses from the system
Should be used to identify wrong entries
Changes can be requested using the “ClinPhone Support Correction Form”
Alerts
Late medication arrival alert

13. Accessing the system using Single User Log-on A new concept!

14. Single User Log-on (SUL)
One Access code and PIN (for the same Sponsor) can be used for both IWR and IVR
Only applicable if you are provided with an access code envelope containing a 16-digit temporary identification number (TIN)
IWR
Reliable Internet Connection
IVR
A touch tone telephone
Access to an external telephone line
The free phone number to call ClinPhone
Single User Log On (SUL) is a new way of granting users access to the IVR, IWR, Web Reporting, Clinphone Drug Accountability (CDA) and any current and future web offerings in development
Users go to one place to access IWR, Web Reporting and CDA and any other future web offerings and only need to remember one access code and PIN PER CLIENT.
All 8 digit access codes are allocated during account set-up, only when needed so there is no wastage in allocating access codes that will not be used.

15. Accessing IVRS & IWRS
The 16 digit TIN is found inside the access code envelope
Lundbeck
Protocol Number: 12402A
ClinPhone Reference: LUN011
User type: Investigator
00001
16-digit
Temporary Identification number (TIN)
Inside of
envelope

16. The IVRS/IWRS User Pack
User manual
Call Worksheets
IVRS Guide

17. Accessing IVR

18. Accessing IVR First call Allocate New Access Code
Complete the envelope activation worksheet before the call
Dial the toll-free phone number
Enter 16-digit TIN
Enter the language you wish to hear
Select ‘Allocate New Access Code’:
Allocate New Access Code
Enter your initials
Enter a new 4-digit PIN
Enter the site number
Record your 8-digit Access Code

19. Accessing IVR Subsequent calls Enter your 8-digit Access Code
Enter your 4-digit PIN
The site user will then hear “Welcome to the Lundbeck 12402A/12649A study” and the menu options:
Randomization call press 1
Emergency Re-supply call press 2
Medication arrival call press 3
Damaged medication call press 4
Code Break call press 5
Training System press 6

20. Accessing IWR

21. Accessing IWR Creating ‘My ClinPhone Account’
Log on to
If you have not created ‘My ClinPhone Account’ before select register new

22. Creating ‘My ClinPhone Account’
Fill in your details:

23. Creating ‘My ClinPhone Account’
You now have set up a ‘My ClinPhone Account’
Confirmation will be sent to your

24. Accessing IWR – First Session
When Logging on to you can now select ‘Enter My ClinPhone Online’

25. Accessing IWR – First Session

26. Accessing IWR – First Session
Country Code
64 =USA

27. Accessing IWR – Subsequent session

28. Important Points to Consider
Complete the worksheet before accessing IVRS/IWRS
Envelope Activation Worksheet must be signed and dated
Represents a personal acceptance of electronic signature
Compliance with FDA Part 11
Access to ClinPhone should not be shared, the 4-digit PIN should be kept confidential

29. Getting help and advice

30. Getting help or advice ClinPhone Support -24/7 end user support
Free Phone
ClinPhone IVR related queries only
24/7 availability
Toll-free number available
Request change of data
Needs to be documented
Use Correction Form
Access problems
locked/barred access codes
User manual FAQ and trouble shooting
Missing notifications/alerts/reports
request re-sent

31. ClinPhone Support Please provide:
ClinPhone study code (LUN011 or LUN012)
Protocol number (12402A or 12649A)
Your contact details
Please remember:
Be as specific as you can
May ask you to confirm certain requests in writing
May need to consult the sponsor

32. Any Questions?