ClinPhone is now part of the Perceptive Informatics® family. Randomization and Trial Supply Management using IVRS/IWRS Lundbeck 12402A & 12649A

ClinPhone is now part of the Perceptive Informatics® family.

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?

• 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

What is IVRS/IWRS?


Medication Management


IVRS/IWRSFunctionalities & 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.


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

Randomization


Enter: • Screening number• Subject’s Date of Birth (for verification)• 4 digit PIN

Outcome:• Patient is re-supplied• New Pack number to dispense

Emergency Re-Supply


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.


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


Accessing the systemusing Single User Log-on

A new concept!

ClinPhoneClinPhone


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


Accessing IVRS & IWRS

Lundbeck

Protocol Number: 12402A

ClinPhone Reference: LUN011

User type: Investigator

00001

16-digit

Temporary Identification number (TIN)

1234567890123456

Inside of envelope

The 16 digit TIN is found inside the access code envelope


The IVRS/IWRS User Pack

User manual Call Worksheets IVRS Guide


Accessing IVR

ClinPhoneClinPhone


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 hearSelect ‘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 Code64 =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: [email protected]

• Free Phone

- ClinPhone IVR related queries only http://www.clinphone.com/support/phones/


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?

Documents

ClinPhone is now part of the Perceptive Informatics® family. Randomization and Trial Supply Management using IVRS/IWRS Lundbeck 12402A & 12649A