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

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Presentation on theme: "ClinPhone is now part of the Perceptive Informatics® family. Randomization and Trial Supply Management using IVRS/IWRS Lundbeck 12402A & 12649A."— Presentation transcript:

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

2 ClinPhone is now part of the Perceptive Informatics® family. 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 ClinPhone is now part of the Perceptive Informatics® family. 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?

4 ClinPhone is now part of the Perceptive Informatics® family. Medication Management

5 ClinPhone is now part of the Perceptive Informatics® family. IVRS/IWRS Functionalities & User Responsibilities

6 ClinPhone is now part of the Perceptive Informatics® family. 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 ClinPhone is now part of the Perceptive Informatics® family. 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 ClinPhone is now part of the Perceptive Informatics® family. 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 ClinPhone is now part of the Perceptive Informatics® family. Enter: Screening number Subjects Date Of Birth Subjects NIHSS Score Date of Stroke Onset Time of Stroke Onset (24 hour clock format) Subjects weight (in Kilograms) 4 digit PIN Outcome: Patient is Randomized Pack number dispensed Dose to administer is calculated Randomization

10 ClinPhone is now part of the Perceptive Informatics® family. Enter: Screening number Subjects Date of Birth (for verification) 4 digit PIN Outcome: Patient is re-supplied New Pack number to dispense Emergency Re-Supply

11 ClinPhone is now part of the Perceptive Informatics® family. 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 ClinPhone is now part of the Perceptive Informatics® family. Reporting Real time notifications 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 ClinPhone is now part of the Perceptive Informatics® family. Accessing the system using Single User Log-on A new concept!

14 ClinPhone is now part of the Perceptive Informatics® family. 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 ClinPhone is now part of the Perceptive Informatics® family. Accessing IVRS & IWRS Lundbeck Protocol Number: 12402A ClinPhone Reference: LUN011 User type: Investigator digit Temporary Identification number (TIN) Inside of envelope The 16 digit TIN is found inside the access code envelope

16 ClinPhone is now part of the Perceptive Informatics® family. The IVRS/IWRS User Pack User manualCall WorksheetsIVRS Guide

17 ClinPhone is now part of the Perceptive Informatics® family. Accessing IVR

18 ClinPhone is now part of the Perceptive Informatics® family. 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 ClinPhone is now part of the Perceptive Informatics® family. 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 ClinPhone is now part of the Perceptive Informatics® family. Accessing IWR

21 ClinPhone is now part of the Perceptive Informatics® family. Accessing IWR Creating My ClinPhone Account Log on to If you have not created My ClinPhone Account before select register new

22 ClinPhone is now part of the Perceptive Informatics® family. Creating My ClinPhone Account Fill in your details:

23 ClinPhone is now part of the Perceptive Informatics® family. Creating My ClinPhone Account You now have set up a My ClinPhone Account Confirmation will be sent to your

24 ClinPhone is now part of the Perceptive Informatics® family. Accessing IWR – First Session When Logging on to you can now select Enter My ClinPhone Online

25 ClinPhone is now part of the Perceptive Informatics® family. Accessing IWR – First Session

26 ClinPhone is now part of the Perceptive Informatics® family. Accessing IWR – First Session Country Code 64 =USA

27 ClinPhone is now part of the Perceptive Informatics® family. Accessing IWR – Subsequent session

28 ClinPhone is now part of the Perceptive Informatics® family. 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 ClinPhone is now part of the Perceptive Informatics® family. Getting help and advice

30 ClinPhone is now part of the Perceptive Informatics® family. Getting help or advice ClinPhone Support -24/7 end user support Free Phone - ClinPhone IVR related queries only

31 ClinPhone is now part of the Perceptive Informatics® family. 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 ClinPhone is now part of the Perceptive Informatics® family. Any Questions?


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