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Dr. Michael Schiff, MD

Dr. Michael Schiff, MD. CERT-001 Interactive Voice/Web Response System (IXRS). Almac Clinical Technologies. IXRS Project Team. Kat Williams Project Manager Dawn Richardson Project Specialist (sites’ main contact). Almac Provides. Centralized subject screening and enrollment

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Dr. Michael Schiff, MD

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  1. Dr. Michael Schiff, MD CERT-001 Interactive Voice/Web Response System (IXRS) Almac Clinical Technologies CONFIDENTIALWWW.ALMACGROUP.COM

  2. IXRS Project Team Kat Williams Project Manager Dawn RichardsonProject Specialist(sites’ main contact) CONFIDENTIALWWW.ALMACGROUP.COM

  3. Almac Provides • Centralized subject screening and enrollment • Automated drug ordering and resupply • IXRS-related site training and project support • IXRS User Materials • Detailed Practice Instructions • 24x7x365 Technical Support CONFIDENTIALWWW.ALMACGROUP.COM

  4. IXRS Site Reference Materials Dr. Michael Schiff, MD Protocol: CERT-001 IXRS Quick Reference Document Almac Clinical Technologies Office Numbers USA : 877-738-8831 • IXRS Quick Reference Document (QRD) • Introduction Letter w/ User ID and Password • Practice Site Information • Additional User Request Form CONFIDENTIALWWW.ALMACGROUP.COM

  5. User ID and Password • Each user will have a unique User ID and Password. • User IDs/Passwords will be distributed by ALMAC to each identified user at your site. • Passwords will be changed upon the first transaction in the IXRS. • Passwords are the electronic equivalent to your signature and must be kept confidential. • Same User ID/Password can access both the phone and web-based system. CONFIDENTIALWWW.ALMACGROUP.COM

  6. IXR System Overview CONFIDENTIALWWW.ALMACGROUP.COM

  7. Accessing the IXRS • Dial the toll-free IXRS number: 1-877-965-4877 OR • Access the secured web site address listed on the QRD • Enter the 6-digit Study Code: 403128 • Enter your 8-digit User ID and 7-digit Password • “Welcome to the CERT-001 IXRS” CONFIDENTIALWWW.ALMACGROUP.COM

  8. IXRS Web Interface Screen CONFIDENTIALWWW.ALMACGROUP.COM

  9. Language Menu The IXRS offers the following language: 01 English CONFIDENTIALWWW.ALMACGROUP.COM

  10. Main Menu Options (Site) The IXRS main menu offers access to the following options: 01 Screen a subject 02 Acknowledge receipt of study medication 03 Randomize a subject 04 Discontinue a subject Obtain subsequent drug assignment 05 Obtain subsequent drug assignment 07 Screen fail 10 Unblind a subject (PI only) 00 To access Technical Support 99 To exit system CONFIDENTIALWWW.ALMACGROUP.COM

  11. Main Menu Options (Admin) The IXRS main menu offers access to the following options: 06 Site Management 00 To access Technical Support 99 To exit system CONFIDENTIALWWW.ALMACGROUP.COM

  12. Initial Drug Shipment Dr. Michael Schiff, MD provides admin approval for site via IXRS* • Triggers IXRS user materials to be sent to site. Almac submits initial study drug request to depot Depot ships study drug to site Confirm shipment via IXRS Site receives drug CONFIDENTIALWWW.ALMACGROUP.COM

  13. Subject enrollment and projected drug usage Resupply Drug Shipment Almac submits resupply study drug request to depot Depot ships study drug to site Confirm shipment via IXRS Site receives drug CONFIDENTIALWWW.ALMACGROUP.COM

  14. Acknowledge Receipt of Study Drug What you will need: • 5-digit Shipment Number • Quantity of Kits • Condition of shipment • 5-digit Kit Number(s)* *to report kit(s) that are damaged What you will receive: • Confirmation Fax CONFIDENTIALWWW.ALMACGROUP.COM

  15. Confirming Shipments Confirming drug shipments is an important process! • Why is it so important?Confirmation in the IXRS registers each study drug shipment as “available for use” at the study site. • What happens if the shipment has not been confirmed?If a shipment is not confirmed in the IXRS, that shipment and the drug inventory at a site can not be accurately tracked. Therefore, drug from that shipment cannot be assigned to subjects. CONFIDENTIALWWW.ALMACGROUP.COM

  16. Screen a Subject What you will need: • Subject’s DOB (dd-mm-yyyy)/(mm-dd-yyyy) • Subject’s Gender • Subject’s Initials What you will receive: • 6-digit Subject ID • Confirmation Fax CONFIDENTIALWWW.ALMACGROUP.COM

  17. Randomize a Subject What you will need: • 6-digit Subject ID • Confirm Subject’s DOB What you will receive: • 5-digit Kit Numbers (2 kits) • Confirmation Fax CONFIDENTIALWWW.ALMACGROUP.COM

  18. Receive a Subsequent Assignment What you will need: • 6-digit Subject ID • Confirm Subject’s DOB • Visit Number (use chart in QRD) What you will receive: • 5-digit Kit Numbers • Confirmation Fax CONFIDENTIALWWW.ALMACGROUP.COM

  19. Discontinue a Subject What you will need: • 6-digit Subject ID • Confirm Subject’s DOB • Discontinuation Date • Discontinuation Reason What you will receive: • Confirmation Fax CONFIDENTIALWWW.ALMACGROUP.COM

  20. Screen Fail a Subject What you will need: 6-digit Subject ID Confirm Subject’s DOB Screen Fail Date Screen Fail Reason What you will receive: • Confirmation Fax CONFIDENTIALWWW.ALMACGROUP.COM

  21. Unblind a Subject What you will need: • Confirmation to unblind Subject • 6-digit Subject ID • Subject’s DOB What you will receive: • Subject Specific Treatment Information • Confirmation Fax *Note: Treatment information will not appear on confirmation fax CONFIDENTIALWWW.ALMACGROUP.COM

  22. IXRS Transaction Confirmations Dr. Michael Schiff, MD Protocol: CERT-001 Subject Subsequent Assignment Confirmation IXRS Site Number: 10 Investigator Name: David Smith, MD Institution: University of Colorado Health Science Center Name of IXRS User: Bart Simpson IXRS User Fax Number: 303-315-1806 ___________________________________________________ Subject ID: 102811 Date of Birth: 06-Mar-1956 Visit Number: 3 Kit(s) Assigned: 31353, 31357 IXRS Transaction Date: <Today’s Date> If any information contained in this fax/email is incorrect please strike-through incorrect data, record the correct data next to the incorrect data, sign and date below and fax the corrected form to: 267-685-4262 ___________________________________________________ Signature Print Name Date CONFIDENTIALWWW.ALMACGROUP.COM

  23. Correcting Incorrect Data • Every IXRS transaction produces a confirmation fax • Use faxes to correct data • Draw a line through the item to be corrected • Write the correct data, today’s date, and your initials • Fax to Almac Clinical Technologies • When appropriate, Almac will send a revised fax with the new data • If urgent, call Almac to report the change CONFIDENTIALWWW.ALMACGROUP.COM

  24. Fax Corrections How to document corrections on confirmation faxes: JS14/01/06 Subject ID: 99901 Date of Birth: 05-Jun-1976 05-Jun-1972 CONFIDENTIALWWW.ALMACGROUP.COM

  25. World Wide Locations Technical Support Center (24x7x365) Phone: Through IXRS or 1-877-738-8831 E-mail: IVRSSupport@almacgroup.com AT&T Language Line is available • Technology & Service Headquarters • Yardley, PA, USA • Satellite Service Offices • San Francisco, CA, USA • Craigavon, UK CONFIDENTIALWWW.ALMACGROUP.COM

  26. CONFIDENTIALWWW.ALMACGROUP.COM

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