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.
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Randomization and Trial Supply Management using IVRS/IWRSLundbeck 12402A & 12649A
What is IVRS/IWRS?
Why Do we Use it?
IVRS/IWRSFunctionalities & User Responsibilities
Investigators and Study Coordinators:
Register medication as having arrived at the site within correct temperature range, and register any medication as missing or damaged.
Register previously arrived medication as missing or damaged
Randomise an eligible patient into the study
Re-supply a patient with additional blinded medication
Code break a patient to reveal the treatment group assigned at randomisation
Available for both investigators and Study Coordinators
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.
Lundbeck will be notified immediately following the call and the patient will automatically be withdrawn from the trial.
Real time notifications
Accessing the systemusing Single User Log-onA new concept!
Protocol Number: 12402A
ClinPhone Reference: LUN011
User type: Investigator
Temporary Identification number (TIN)
Select ‘Allocate New Access Code’:
Allocate New Access Code
The site user will then hear “Welcome to the Lundbeck 12402A/12649A study” and the menu options:
Log on to www.clinphone.com/signin
If you have not created ‘My ClinPhone Account’ before select register new
Fill in your details:
You now have set up a ‘My ClinPhone Account’
Confirmation will be sent to your e-mail
When Logging on to www.clinphone.com/signin, you can now select ‘Enter My ClinPhone Online’
Getting help and advice
ClinPhone Support -24/7 end user support