Transcript iStar

iStar
How to start a new
Protocol
iStar Basics Training Course
For Investigators
http://istartraining-chla.usc.edu
What You Will Learn
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Site navigation
Creating application for new studies
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Using SmartForms
Different types of questions
Prerequisites for submission
The application review process
Where to get help
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Program Overview
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Web application
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Secure environment
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Multiple browser support
Limited Macintosh support (not Safari)
Username and Password required
SQL database on server
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Central storage for all data
All users see the same version
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Obtain iStar account
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For CHLA users:
Please contact the main phone number: 323-361-2265
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For UPC and HSC users:
Obtaining an iStar Account - follow steps below
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Put iStar Account Request in the subject line of an email.
Include the following in the body of the email:
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Last, First (Middle) - please provide your name in this order
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campus*
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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.
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email address
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user role**
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phone number
Send the email to [email protected].
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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.
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* 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...
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Sites
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iStar website
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https://istar-chla.usc.edu
Must obtain iStar account to start a study or participate
in the study
iStar Training (Sandbox) website
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http://istartraining-chla.usc.edu
Training usernames are provided on the website
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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
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Personal Folder
Breadcrumb
Navigator
Header
Top Navigator
Bar
New
Study
Button
Tabbed
Area
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Types of Questions in iStar
TEXT BOX
YES/NO RADIO BUTTON
VS.
SELECT ONE (radio button) VS. MULTIPLE THINGS (check boxes)
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Types of Questions in iStar (cont’d)
DROP-DOWN SELECTION
VS.
SINGLE VS. MULTIPLE PERSON SELECTION
FILE ATTACHMENT
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Single Person Selection
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Multiple Person Selection
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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!
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Study Workspace
Summary Panel
Tabbed Area
Left-hand column
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Validation Check
SmartForm Progress
Hide/Show errors
Also on Submit Activity
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Use SmartForm Progress
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Submitting the Study
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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.
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Routing and Review
4b) Expedited/Exempt
Review
1) PreSubmission
2) Pre-Review
3) IRB Staff
Review
4a) Full Committee
Meeting
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6) Approved
5) Contingency
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.
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Responding to Contingencies
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Study team will receive email notification
View the correspondence in the history log
Anyone on study team can edit the application
Respond to contingencies
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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
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Study Approval
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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 RE’s, AM’s,
and CR’s
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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.
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iStar shortcuts cont’d
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 don’t
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
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Production Information
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Official Site: http://istar-chla.usc.edu
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Mandatory Use for all New Studies
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Training Resources
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All resources found under Training Resources
Application Questions
User Guide for Investigators
Information “Quick” Sheets
“Sandbox” Mode (Training Site)
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Where To Get Help
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IRB Office: Content questions
Technical Support:
Yana Gorelik – iStar Technical Support
[email protected]
(323) 276-2238
Martin Koning Bastiaan - iStar Director
[email protected]
(323) 276-2232
We welcome all Questions & Comments
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