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

1. Randomization and Trial Supply Management using IVRS/IWRSLundbeck 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? • 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. MedicationManagement

5. IVRS/IWRSFunctionalities & 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: • 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: • 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: • 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 • Faxed/e-mailed 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 systemusing Single User Log-onA 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

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) 1234567890123456 Inside of envelope

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

17. Accessing IVR

18. Accessing IVR First call • 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 www.clinphone.com/signin 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 e-mail

24. Accessing IWR – First Session When Logging on to www.clinphone.com/signin, 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 • E-mail: support@ClinPhone.com • Free Phone • ClinPhone IVR related queries only http://www.clinphone.com/support/phones/

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?