Presentation on theme: "Agenda What is IVRS/IWRS? How it works to manage your medication"— Presentation transcript:
1 Randomization and Trial Supply Management using IVRS/IWRS Lundbeck 12402A & 12649A
2 Agenda What is IVRS/IWRS? How it works to manage your medication Functionalities & User ResponsibilitiesSingle User Log-OnAccessing IVRAccessing IWRGetting help and adviceDemonstration
3 What is IVRS/IWRS? What is IVRS/IWRS? Why Do we Use it? Interactive Voice Response System/ Interactive Web Response SystemTouch tone technology and interactive web based technologyUser responds to instructions using keypad/keyboardDirect interaction with global databaseWhy Do we Use it?Assists in maintaining Randomization balanceEnsures medication stocks are maintained at sites
5 IVRS/IWRS Functionalities & User Responsibilities
6 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 MedicationRegister previously arrived medication as missing or damaged
7 Call Options Investigators only: Randomisation Randomise an eligible patient into the studyEmergency Re-SupplyRe-supply a patient with additional blinded medicationSite Code BreakCode break a patient to reveal the treatment group assigned at randomisation
8 Medication Arrival and Damaged Medication Available for both investigators and Study CoordinatorsEnter:Consignment number (for Medication Arrival)Answer the question on the temperature rangeDamaged medication numberOutcome:Registers the arrival of a consignment of medication at the siteThe IMP will be released or quarantined depending on the temperatureDamaged/missing medication will be replacedIn 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 Randomization Enter: Outcome: Screening number Subject’s Date Of Birth Subject’s NIHSS ScoreDate of Stroke OnsetTime of Stroke Onset (24 hour clock format)Subject’s weight (in Kilograms)4 digit PINOutcome:Patient is RandomizedPack number dispensedDose to administer is calculated
10 Emergency Re-Supply Enter: Outcome: Screening number Subject’s Date of Birth (for verification)4 digit PINOutcome:Patient is re-suppliedNew Pack number to dispense
11 Emergency Code Break Enter: Outcome: Screening number Confirm medically necessary to break the Randomization code4-digit PINOutcome:ClinPhone will read out the patients Randomized treatment groupLundbeck will be notified immediately following the call and the patient will automatically be withdrawn from the trial.
12 Reporting Real time notifications Alerts Faxed/ ed following each callFile with other study related documentationLists all entries and all responses from the systemShould be used to identify wrong entriesChanges can be requested using the “ClinPhone Support Correction Form”AlertsLate medication arrival alert
13 Accessing the system using Single User Log-on A new concept!
14 Single User Log-on (SUL) One Access code and PIN (for the same Sponsor) can be used for both IWR and IVROnly applicable if you are provided with an access code envelope containing a 16-digit temporary identification number (TIN)IWRReliable Internet ConnectionIVRA touch tone telephoneAccess to an external telephone lineThe free phone number to call ClinPhoneSingle User Log On (SUL) is a new way of granting users access to the IVR, IWR, Web Reporting, Clinphone Drug Accountability (CDA) and any current and future web offerings in developmentUsers go to one place to access IWR, Web Reporting and CDA and any other future web offerings and only need to remember one access code and PIN PER CLIENT.All 8 digit access codes are allocated during account set-up, only when needed so there is no wastage in allocating access codes that will not be used.
15 Accessing IVRS & IWRSThe 16 digit TIN is found inside the access code envelopeLundbeckProtocol Number: 12402AClinPhone Reference: LUN011User type: Investigator0000116-digitTemporary Identification number (TIN)Inside ofenvelope
16 The IVRS/IWRS User Pack User manualCall WorksheetsIVRS Guide
18 Accessing IVR First call Allocate New Access Code Complete the envelope activation worksheet before the callDial the toll-free phone numberEnter 16-digit TINEnter the language you wish to hearSelect ‘Allocate New Access Code’:Allocate New Access CodeEnter your initialsEnter a new 4-digit PINEnter the site numberRecord your 8-digit Access Code
19 Accessing IVR Subsequent calls Enter your 8-digit Access Code Enter your 4-digit PINThe site user will then hear “Welcome to the Lundbeck 12402A/12649A study” and the menu options:Randomization call press 1Emergency Re-supply call press 2Medication arrival call press 3Damaged medication call press 4Code Break call press 5Training System press 6
28 Important Points to Consider Complete the worksheet before accessing IVRS/IWRSEnvelope Activation Worksheet must be signed and datedRepresents a personal acceptance of electronic signatureCompliance with FDA Part 11Access to ClinPhone should not be shared, the 4-digit PIN should be kept confidential
30 Getting help or advice ClinPhone Support -24/7 end user support Free PhoneClinPhone IVR related queries only24/7 availabilityToll-free number availableRequest change of dataNeeds to be documentedUse Correction FormAccess problemslocked/barred access codesUser manual FAQ and trouble shootingMissing notifications/alerts/reportsrequest re-sent
31 ClinPhone Support Please provide: ClinPhone study code (LUN011 or LUN012)Protocol number (12402A or 12649A)Your contact detailsPlease remember:Be as specific as you canMay ask you to confirm certain requests in writingMay need to consult the sponsor