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iStar How to start a new Protocol

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iStar How to start a new Protocol iStar Basics Training Course For Investigators http://istartraining-chla.usc.edu What You Will Learn Site navigation Creating ... – PowerPoint PPT presentation

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Title: iStar How to start a new Protocol


1
iStar How to start a new Protocol
  • iStar Basics Training Course
  • For Investigators
  • http//istartraining-chla.usc.edu

2
What You Will Learn
  • Site navigation
  • Creating application for new studies
  • Using SmartForms
  • Different types of questions
  • Prerequisites for submission
  • The application review process
  • Where to get help

3
Program Overview
  • Web application
  • Multiple browser support
  • Limited Macintosh support (not Safari)
  • Secure environment
  • Username and Password required
  • SQL database on server
  • Central storage for all data
  • All users see the same version

4
Obtain iStar account
  • For CHLA users Please contact the main phone
    number 323-361-2265
  • For UPC and HSC users Obtaining an iStar Account
    - follow steps below
  • Put   iStar Account Request   in the subject line
    of an email.
  • Include the following in the body of the email
  • Last, First (Middle)  - please provide your name
    in this order
  • campus
  • division and department (be specific) - if you
    are not sure, please provide a PI or Faculty
    Advisor of the study that you will be
    a participant of.
  • email address
  • user role
  • phone number 
  • Send the email to istar_at_usc.edu.
  • You may include more than one persons request in
    the same email.  Within one business day, you
    will receive an email with your user name and
    temporary password.  Use this information to
    login to you iStar account.
  • Specify campus as either USC - Health Sciences,
    USC - University Park, or CHLA - Childrens
    Hospital LA. Some of the user roles are
    Faculty Advisor, PI/Staff and etc...

5
Sites
  • iStar website
  • https//istar-chla.usc.edu
  • Must obtain iStar account to start a study or
    participate in the study
  • iStar Training (Sandbox) website
  • http//istartraining-chla.usc.edu
  • Training usernames are provided on the website

6
Training Site Location
http//istartraining-chla.usc.edu/
Username pi1-chla, pi2-chla, pi3-chla
pi1-hsc, pi2-hsc, pi3-hsc
pi1-upc, pi3-upc, pi3-upc Password 1234
7
Personal Folder
Breadcrumb Navigator
Header
Top Navigator Bar
New Study Button
Tabbed Area
8
Types of Questions in iStar
TEXT BOX
YES/NO RADIO BUTTON
VS.
SELECT ONE (radio button) VS. MULTIPLE THINGS
(check boxes)
9
Types of Questions in iStar (contd)
DROP-DOWN SELECTION
VS.
SINGLE VS. MULTIPLE PERSON SELECTION
FILE ATTACHMENT
10
Single Person Selection
11
Multiple Person Selection
12
Attaching a Document (.doc .xls)
Document must be saved on your desktop, floppy
disk or somewhere on the computer for you to
upload it into iStar!
13
Study Workspace
Summary Panel
Tabbed Area
Left-hand column
14
Validation Check
  • SmartForm Progress
  • Hide/Show errors
  • Also on Submit Activity

15
Use SmartForm Progress
16
(No Transcript)
17
Submitting the Study
  • Submission Instructions
  • Send Study Ready Notification
  • All Co-Investigators must agree to participate
  • Principal Investigator is required to execute the
    submit activity (CCI, UP or HS)
  • Anyone on the study team can respond to change
    requests
  • When the study is submitted, a new ID number will
    be assigned. This new ID number will be the
    official IRB Study number.

18
Routing and Review
  • Routing is based on questions and actions
  • Activities might change depends on the Study
    State
  • Email notifications sent to study team
  • All actions and correspondence are logged
  • Approval letter and approved consent forms are
    posted in the study folder
  • You must have Human Subjects Certification to
    participate in the Study.

19
Responding to Contingencies
  • Study team will receive email notification
  • View the correspondence in the history log
  • Anyone on study team can edit the application
  • Respond to contingencies
  • Make necessary changes to the study
  • Copy-and-paste contingency list from the letter
    into the response text box
  • Under each contingency item explain what you did
  • Any study team member may submit the response

20
Study Approval
  • Study team will receive email notification
  • The approval letter appears in the summary panel
    and history log
  • Approved consent forms in Documents tab
  • Tabbed area has Amendments, Continuing Reviews,
    Reportable Events and Documents
  • Left-hand side has create buttons for REs, AMs,
    and CRs

21
iStar shortcuts
  • Select Jump To to jump to different SmartForm
    page when updating the study, amendment,
    continuing review or adverse event

Select the page you need to update. When you
finish with changes, you can click on Save and
then Exit (on the gray menu bar) to get back to
the workspace.
22
iStar shortcuts contd
  • To check the status of your study or AM or CR or
    AE when it is not in your inbox, select Studies
    on Top Navigator Bar (black header)

Your study will appear under In Progress or
Approved tabs. If you forgot the whole title
of your study and dont remember the Study, you
can type in partial title with in front or
after the partial title. Example Full title
Drug and Medicine Abuse. In the text box next
to Go, you can type the following
medicine All studies with word medicine in the
title will be available for you. - wild card
23
Production Information
  • Official Site http//istar-chla.usc.edu
  • Mandatory Use for all New Studies

24
Training Resources
  • All resources found under Training Resources
  • Application Questions
  • User Guide for Investigators
  • Information Quick Sheets
  • Sandbox Mode (Training Site)

25
Where To Get Help
  • IRB Office Content questions
  • Technical Support
  • Yana Gorelik iStar Technical Support
  • istar_at_usc.edu
  • (323) 276-2238
  • Martin Koning Bastiaan - iStar Director
  • martin.kb_at_usc.edu
  • (323) 276-2232
  • We welcome all Questions Comments
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