AVEO PROTOCOL AV-951-10-201 INTERACTIVE WEB RESPONSE SYSTEM (IWRS) Version 0.1 – 18 February 2011.

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Presentation transcript:

AVEO PROTOCOL AV INTERACTIVE WEB RESPONSE SYSTEM (IWRS) Version 0.1 – 18 February 2011

General Information about the IWRS: Accessible via the World Wide Web Available 24 hours/day, 7 days/week Importance of IWRS Use for AV IWRS System Menu Options & Functions After each function, the user will have the opportunity to print the screen with information. IWRS Confirmations will be sent to the site for each function. © 2011 INC Research, LLC 2 OVERVIEW

An IWRS Site User is any person at a site responsible for logging into the system Each site will receive an IWRS Quick Reference Guide © 2011 INC Research, LLC 3 IWRS USERS

Principal Investigators, Unblinded Pharmacists, or Study Coordinators When a site is approved to receive study drug the site will be activated in the IWRS and each IWRS Site User will receive a unique User ID and password for the IR Portal and IWRS via User passwords must not be shared with others. Sharing passwords is against 21 CFR Part 11 © 2011 INC Research, LLC 4 IWRS USERS

1.Enter the following URL in Internet Explorer (other browsers will not work): 2.Log on to IR Portal (the first security access screen into the IWRS) with username and password 3.Click on the “AVEO AV ” link 4.Log on to IWRS with User ID and password 5.Confirm your site number © 2011 INC Research, LLC 5 LOGGING ON

© 2011 INC Research, LLC 6 LOGGING ON

© 2011 INC Research, LLC 7 LOGGING ON

© 2011 INC Research, LLC 8 LOGGING ON

© 2011 INC Research, LLC 9 LOGGING ON

Acknowledge Receipt of Drug Shipment (Pharmacists) Discontinue Subjects (Investigators) Drug Supply – Manual Drug Reordering (Pharmacists) Registration (Investigators) Note: Study Coordinators see all four functions. Investigators and Pharmacists see only those functions specified for them above. © 2011 INC Research, LLC 10 IWRS MAIN MENU

© 2011 INC Research, LLC 11 MAIN MENU (INVESTIGATORS)

© 2011 INC Research, LLC 12 MAIN MENU (PHARMACISTS)

© 2011 INC Research, LLC 13 MAIN MENU (STUDY COORDINATORS)

Select the drug order number Enter whether the shipment was received in complete and good condition. If not, you will need to specify if the entire shipment was damaged/missing. If the entire shipment was not missing, you will be prompted to enter how much of each drug type was damaged/missing. Verify the information Click Submit © 2011 INC Research, LLC 14 ACKNOWLEDGE RECEIPT OF DRUG SHIPMENT

© 2011 INC Research, LLC 15 ACKNOWLEDGE RECEIPT OF DRUG SHIPMENT

© 2011 INC Research, LLC 16 ACKNOWLEDGE RECEIPT OF DRUG SHIPMENT

© 2011 INC Research, LLC 17 ACKNOWLEDGE RECEIPT OF DRUG SHIPMENT

© 2011 INC Research, LLC 18 ACKNOWLEDGE RECEIPT OF DRUG SHIPMENT

© 2011 INC Research, LLC 19 ACKNOWLEDGE RECEIPT OF DRUG SHIPMENT

Select the subject to discontinue from the drop-down menu Verify the subject’s gender and date of birth. Enter the discontinuation date Verify the information entered Click “Submit” © 2011 INC Research, LLC 20 DISCONTINUE SUBJECT

© 2011 INC Research, LLC 21 DISCONTINUE SUBJECT

© 2011 INC Research, LLC 22 DISCONTINUE SUBJECT

© 2011 INC Research, LLC 23 DISCONTINUE SUBJECT

© 2011 INC Research, LLC 24 DISCONTINUE SUBJECT

© 2011 INC Research, LLC 25 DISCONTINUE SUBJECT

© 2011 INC Research, LLC 26 DISCONTINUE SUBJECT

Enter the quantity for each drug type you wish to order Verify the information entered. Click “Submit” © 2011 INC Research, LLC 27 DRUG SUPPLY – MANUAL DRUG REORDERING

© 2011 INC Research, LLC 28 DRUG SUPPLY – MANUAL DRUG REORDERING

© 2011 INC Research, LLC 29 DRUG SUPPLY – MANUAL DRUG REORDERING

© 2011 INC Research, LLC 30 DRUG SUPPLY – MANUAL DRUG REORDERING

Enter the following information: Subject number Date of birth Gender Subject’s histology Click “Submit” Verify the information. If it is correct click “Confirm” © 2011 INC Research, LLC 31 REGISTRATION

© 2011 INC Research, LLC 32 REGISTRATION

© 2011 INC Research, LLC 33 REGISTRATION

© 2011 INC Research, LLC 34 REGISTRATION

© 2011 INC Research, LLC 35 REGISTRATION

Retain all IWRS correspondence in the appropriate section of the study file: Confirmation of Acknowledge of Receipt of Drug Shipment Confirmation of Discontinuation of Subject Confirmation of Manual Drug Reordering Confirmation of Registration © 2011 INC Research, LLC 36 IWRS CORRESPONDENCE

© 2011 INC Research, LLC 37 CONFIRMATION OF ACKNOWLEDGE RECEIPT OF DRUG SHIPMENT

© 2011 INC Research, LLC 38 CONFIRMATION OF DISCONTINUATION OF SUBJECT

© 2011 INC Research, LLC 39 CONFIRMATION OF DRUG RESUPPLY ORDER

© 2011 INC Research, LLC 40 CONFIRMATION OF REGISTRATION

Quick Reference Guides Call the Toll-Free IWRS Help Desk hours a day/7 days a week IWRS Related questions only (all non clinical questions will be referred back to your medical monitor) To remember: If you need to leave a message for the Help Desk please leave the following information: What study you are calling about Site number Name Telephone number where they can reach you Any subject information if applicable © 2011 INC Research, LLC 41 HOW TO RECEIVE HELP

Always acknowledge drug as soon as you receive it. © 2011 INC Research, LLC 42 POINTS TO REMEMBER

QUESTIONS??? © 2011 INC Research, LLC 43