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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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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
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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?
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ClinPhone is now part of the Perceptive Informatics® family.
Medication Management
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ClinPhone is now part of the Perceptive Informatics® family.
IVRS/IWRSFunctionalities & User
Responsibilities
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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
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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
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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.
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ClinPhone is now part of the Perceptive Informatics® family.
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
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ClinPhone is now part of the Perceptive Informatics® family.
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
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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.
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ClinPhone is now part of the Perceptive Informatics® family.
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
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ClinPhone is now part of the Perceptive Informatics® family.
Accessing the systemusing Single User Log-on
A new concept!
ClinPhoneClinPhone
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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
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ClinPhone is now part of the Perceptive Informatics® family.
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
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ClinPhone is now part of the Perceptive Informatics® family.
The IVRS/IWRS User Pack
User manual Call Worksheets IVRS Guide
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ClinPhone is now part of the Perceptive Informatics® family.
Accessing IVR
ClinPhoneClinPhone
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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 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
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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
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ClinPhone is now part of the Perceptive Informatics® family.
Accessing IWR
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ClinPhone is now part of the Perceptive Informatics® family.
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
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ClinPhone is now part of the Perceptive Informatics® family.
Creating ‘My ClinPhone Account’ Fill in your details:
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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 e-mail
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ClinPhone is now part of the Perceptive Informatics® family.
Accessing IWR – First Session When Logging on to www.clinphone.com/signin, you can now select ‘Enter My ClinPhone Online’
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ClinPhone is now part of the Perceptive Informatics® family.
Accessing IWR – First Session
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ClinPhone is now part of the Perceptive Informatics® family.
Accessing IWR – First Session
Country Code64 =USA
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ClinPhone is now part of the Perceptive Informatics® family.
Accessing IWR – Subsequent session
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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
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ClinPhone is now part of the Perceptive Informatics® family.
Getting help and advice
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ClinPhone is now part of the Perceptive Informatics® family.
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/
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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
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ClinPhone is now part of the Perceptive Informatics® family.
Any Questions?