Making Requested Changes to your Protocol

Making Requested Changes to your Protocol
MAKING REQUESTED CHANGES TO YOUR PROTOCOL
BROWSERS:
Supported Browsers - For
If using a PC - Microsoft Internet Explorer version 7.0 or newer.
If using a MAC - for Apple products, IRISS is fully functional and supported in Safari.
Optimum Results:
Other browsers, such as current versions of Netscape Navigator, Mozilla Firefox, or
Chrome may result in some functionality not being fully supported (i.e. date calendar,
text formatting, scroll bars in pop up windows etc).
MAKE CHANGES TO A
PROTOCL:
You will receive an email from the IRISS system indicating that changes or clarifications
are required. Click on the Ethics ID link in the email beside Study ID to go directly to
the Study Workspace.
Throughout the approval
process, you may be asked
by the ACC staff or
Committee to make changes
to your protocol prior to
final approval.
Alternatively, you can enter
the Study Workspace
directly from your Personal
Home page. The protocol
will show in your INBOX click on the name of the
protocol to open the Study
Workspace.
STUDY WORKSPACE:
The Current State of the
protocol will show who is
asking for changes to be
made and that the system is
“….Waiting for Applicant
Response”.
Smartform activty button
now shows as Edit Study. In
this Current State, the Study
Team can now make the
requested changes to the
protocol.
History Tab – shows Changes
Requested and indicates how
many Reviewer Notes have
been logged and gives further
instructions regarding making
changes.
NOTE: In this example, the ACC Committee is
requesting changes to the protocol
REVIEWER NOTES:
Click on the Reviewer Notes
tab to view the requested
changes.
To get to the appropriate
page in the protocol, click on
the page name link beside
Jump To:
MAKING CHANGES AND
RESPONDING TO
REVIEWER NOTES:
The note will indicate which
question is being changed.
Once the change has been
made, scroll back up to the
Reviewer Note, and beside
Response Required! click on
Click here to respond…
A response box will open, the
system defaults the Type: to
Change Request Completed
In the response box, indicate
that the change was made
and add additional comments
if required, and click on the
OK button in the bottom
right hand corner.
If you are not making the
requested changes, choose
Type: Change Request Not
Completed. Indicate the
rationale for not making the
requested change in the
response box and click on the
OK button in the bottom
right hand corner.
If the Reviewer Note is a
Request for Clarification and
no change is necessary,
choose Type: Info Only. Add
your clarification notes in the
response box and click on the
OK button in the bottom
right hand corner.
Once completed, your response will show in green underneath the original request.
Click on Next or Previous on
the yellow navigation bar to
move to the next/previous
note. The system will
automatically save your
changes.
NOTE: if you use the Back
button to move to the previous page, the
changes you made to the current page will not be saved unless you first click on the
Save
button at the top or bottom of the page.
If you click on OK and realize
you would like to add/
change your response, click
on Change Request
Completed to re-open the
response box and make your
changes. Click on OK in the
bottom left hand corner.
Once you have made all the
appropriate changes and
responded to all Reviewer
Notes, click on Save/Exit at
the top or bottom of the of
the page.
This will take you back to the
Study Workspace. To submit
the changes, the PI will click
on the Submit Changes
button under My Activities
on the left had side of the
page.
The system will check to make sure there are no errors or warnings. This may take a
few minutes, please do not close out of the window. Once the system has
determined there are no errors or warnings, it will redirect you to Submit Changes
box.
Add any additional comments (if necessary) and then click on OK in the bottom right
hand corner.
HOW DO I KNOW MY
CHANGES HAVE BEEN
SUBMITTED?
You will know the changes
have been submitted when:
NOTE: Smartform activty button how shows as
View Study. In this Current State, the Study Team
cannot make any additional changes to the
protocol as it is back with the assigned Committee
Members to review the changes.
- Current State of the
protocol changes .
- History Tab shows Changes
Submitted
If you have any questions please contact the IRISS Support at:
email: [email protected]
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