Randomization and trial supply management using ivrs iwrs lundbeck 12402a 12649a
1 / 32

Randomization and Trial Supply Management using IVRS/IWRS Lundbeck 12402A & 12649A - PowerPoint PPT Presentation

  • Uploaded on

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.

I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
Download Presentation

PowerPoint Slideshow about 'Randomization and Trial Supply Management using IVRS/IWRS Lundbeck 12402A & 12649A' - kitty

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.

- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
Randomization and trial supply management using ivrs iwrs lundbeck 12402a 12649a

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


  • 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?

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

Medication management

Ivrs iwrs functionalities user responsibilities

IVRS/IWRSFunctionalities & User Responsibilities

Call options
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 options1
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
Medication Arrival and Damaged Medication

Available for both investigators and Study Coordinators


  • Consignment number (for Medication Arrival)

  • Answer the question on the temperature range

  • Damaged medication number


  • 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.



  • 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


  • Patient is Randomized

  • Pack number dispensed

  • Dose to administer is calculated

Emergency Re-Supply


  • Screening number

  • Subject’s Date of Birth (for verification)

  • 4 digit PIN


  • Patient is re-supplied

  • New Pack number to dispense

Emergency code break
Emergency Code Break


  • Screening number

  • Confirm medically necessary to break the Randomization code

  • 4-digit PIN


  • 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.


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”


  • Late medication arrival alert

Accessing the system using single user log on a new concept

Accessing the systemusing Single User Log-onA new concept!

Single user log on sul
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)


    • Reliable Internet Connection


    • A touch tone telephone

    • Access to an external telephone line

    • The free phone number to call ClinPhone

Accessing ivrs iwrs
Accessing IVRS & IWRS

  • The 16 digit TIN is found inside the access code envelope


Protocol Number: 12402A

ClinPhone Reference: LUN011

User type: Investigator



Temporary Identification number (TIN)


Inside of


The ivrs iwrs user pack
The IVRS/IWRS User Pack

User manual

Call Worksheets

IVRS Guide

Accessing ivr1
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

Accessing ivr2
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 creating my clinphone account
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 account1
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
Accessing IWR – First Session

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

Accessing iwr first session2
Accessing IWR – First Session

Country Code

64 =USA

Important points to consider
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 or advice
Getting help or advice

ClinPhone Support -24/7 end user support

  • E-mail: [email protected]

  • Free Phone

    • ClinPhone IVR related queries only


Clinphone support
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