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

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

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

Medication Management

IVRS/IWRS Functionalities & User Responsibilities

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

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

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.

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

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

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.

Reporting Real time notifications Alerts 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

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

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.

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

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

Accessing IVR

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

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

Accessing IWR

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

Creating ‘My ClinPhone Account’ Fill in your details:

Creating ‘My ClinPhone Account’ You now have set up a ‘My ClinPhone Account’ Confirmation will be sent to your e-mail

Accessing IWR – First Session When Logging on to www.clinphone.com/signin, you can now select ‘Enter My ClinPhone Online’

Accessing IWR – First Session

Accessing IWR – First Session Country Code 64 =USA

Accessing IWR – Subsequent session

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

Getting help and advice

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/ 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

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

Any Questions?