Transcript Interactive Voice Response System Overview

iVTS = interactive Visit
Tracking System
Study:
Study code – V-950-001
Presenter: Charles Head
IM location: Miami, FL
Date: 9 Jan 2007
1
What is iVTS?
• Solution for Enrollment & Visit Tracking
• 24/7 automated system with functionality to:
– Record Visit information
– Record Screen failures / Discontinuations
– Visit transactions can be performed using:
 Phone
 Web (internet via PC)
2
General Access Requirements
• Phone
– Touch-tone service & telephone
• Web
– High speed (Cable/DSL) or dialup access to Internet
– PC with Internet Explorer version 5.0 or higher
• User ID and PIN (used for both Phone or Web)
– Secure Access - Each user is assigned unique User
ID and PIN
• Sharing User IDs and PINs violates FDA 21 CFR Part 11
– PIN Changes Required: At First Login
• Every 6 months
3
Investigator Sites Receive
• User ID & initial PIN for each user
– sent when site is activated, via email or fax
• Site Instructions (One-page Quick Reference)
– Primary/Secondary access codes / link for system use
– Primary/Secondary Help Desk contact info
– Basic guide on system use (both phone & web)
• Additional User Request form & procedure
– New access granted within 24 hours
4
Accessing iVTS
• Phone
– Dial appropriate access code and /
or toll-free telephone number
– Available in local languages
– Enter when prompted:
• User ID / PIN
• Main Menu Options
• Web
– Access web site with provided link
– Login with User ID / PIN
– Select desired option from
ICOPhone Options / Tools
5
Local Languages Supported
• Phone
– English
– others
• Web
– English
6
iVTS Country Phone Numbers
Country
Primary ICOPhone
IVR Number
Secondary ICOPhone IVR
Number
Primary Helpdesk
Secondary Helpdesk
France
0-800-97-02-87
0800-91-8034
0-800-97-03-29
0800-91-4231
Netherlands
0800-022-5327
Dial ATT 0800-022-9111
then 800 594 4977
0800-022-2383
Dial ATT 0800-022-9111
then 888-426-8801
Sweden
020-792651
Dial ATT 020-799-111
then 800 594 4977
020-792490
Dial ATT 020-799-111
then 888 426 8801
United States
800-594-4977
215-616-3601
888-426-8801
281-295-4889
Web
http://www.icophone.com
[email protected]
7
Visit Schedule
Visit #
Visit Description/ Label
Optional/ Required
1
Screening
Required
2
Randomization
Required
3
Follow-up
Required
4
Follow-up
Required
5
Follow-up
Required
6
Dispensing
Required
7
Follow-up
Required
8
Follow-up
Required
9
Dispensing
Required
10
Follow-up
Required
11
Follow-up
Required
12
Follow-up
Required
13
Follow-up
Required
14
Follow-up
Required
15
Follow-up
Required
16
Follow-up
Required
17
Completion
Required
8
Main Menu Options - Phone
Touch Result
1
To Register a Visit
2
3
8
9
0
To Register a Subject as
Discontinued or Screen Failed
To Change your PIN
To hear these options again
To exit the system
To transfer to ICOPhone Help
Desk
9
Main Menu Options - Web
10
ICOPhone Help Desk
Availability
• Live support available 24/7
– Translation services can be provided
• Additional support available via email
– [email protected]
• 24 hour response turnaround
• Contact information printed on all instructions
• All instructions & forms available under
“Study Manual” on web
11
ICOPhone Help Desk
Support Areas
•
•
•
•
Provides User ID / PIN for users
Requests for new / additional users
System functionality
Data entry errors
12
Questions
13