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- How can I access my eIRB account?
- How can I obtain my eIRB username and/or password?
- How can I initiate a continuing review in the eIRB now that
I have converted my study?
- The eIRB requires me to enter a non-OHSU site other
than the sponsor on the
"Non-OHSU Study Activities" form but no non-OHSU sites other than the
sponsor are used. What should I do?
- We have a non-OHSU researcher participating in our studies.
How can we register him/her with the eIRB?
- The links in eIRB e-mail notifications are not working.
Why?
- How can we withdraw our study from the eIRB?
- Our initial/continuing review/modification
has been approved. Where do we find the approved documents such as the
consent form?
- My study was submitted and disappeared from
my eIRB inbox. Where is it?
- Why don't I have an OK button on the "Personnel Selection"
window?
- I receive an error when clicking on the OK
button on the "Personnel Selection" window. What am I doing wrong?
- I keep getting an error during registration but I
have entered all my information correctly?
- How do I know which IRB Analysts are working on
my study?
- I have accidentally answered a radio button.
Can I unanswer it?
- We have revised our IRQ/CRQ and our PI
would like to resubmit it back to the IRB. How can this be done?
- What do I do if I have accidentally answered yes to
the hard copy documents question?
- Is there an eIRB manual and if there is how can
I obtain one?
- How do I know if a study is in "my court" or
if it's being reviewed at the IRB?
- Why is the hard-copy PPQ required to be submitted to the ORIO
in order to have my study processed? I thought that eIRB was a totally paperless
process?
- When/Will electronic signatures be
accepted or integrated through the eIRB system?
- Do I need to fill out a Clinical Billing Schedule?
- Who is required to be listed on the electronic IRQ?
- Do all the individuals listed on the electronic IRQ have to be listed on the consent form?
- My sponsor will not accept the
approval memo that was generated through the system because the Chair
did not sign the memo. Will the IRB be able to print the approval memo
and have it signed so my sponsor can be satisfied?
- Which browsers does the eIRB support?
- How can I change my name in the eIRB?
- How can I access my eIRB account?
Please visit https://eirb.ohsu.edu/irb/
and click on the 'Login' link located in the upper right section of the page.
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How can I obtain my eIRB username and/or password?
You can use the "Forgot Username?" or the "Forgot
Password?" links located below the eIRB login page or contact
the ORIO at (503) 494-7887 or at irbinbox@ohsu.edu.
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How can I initiate a continuing review in the eIRB now that I
have converted my study?
Once you have converted your study, the PI of the study will have
to submit it. Then you will be given the option to initiate a continuing
review.
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The eIRB requires me to enter a non-OHSU site other than the sponsor on the
"Non-OHSU Study Activities" form but no non-OHSU sites other than the sponsor are used.
What should I do?
Please use the "Jump to:" drop-down listbox to open the
"Project Questionnaire" form and uncheck the
check for the question "2.6.10. Research data will be generated, collected,
or analyzed at a non-OHSU Site:"
and the eIRB will exclude the "Non-OHSU Study Activities" form.
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We have a non-OHSU researcher participating in our studies. How can we
register him/her with the eIRB?
For detailed registration instructions for both OHSU and non-OHSU employees please visit
the following web page:
http://www.ohsu.edu/research/rda/eirb/registration.shtml.
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The links in eIRB e-mail notifications are not working. Why?
Unfortunately, GroupWise displays e-mail messages in plain text view
as opposed to HTML view, which causes the links to malfunction. For
a resolution of the issue please read the following
article:
http://www.ohsu.edu/research/rda/eirb/notification_links.shtml.
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How can we withdraw our study from the eIRB?
If your study's status is "Researcher Preparation" or "Converted
Study Researcher Preparation", the PI of the study will have the option
to withdraw it. If the study is in any other status and you would like
to withdraw it please send an e-mail to irbinbox@ohsu.edu
specifying the study number and a brief explanation and we will withdraw
it for you.
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- Our initial/continuing review/modification
has been approved. Where do we find the approved documents such as the
consent form?
Approved study documents are located under the "Study Documents"
tab in the study work-space area. In order to open your study please
select the "Protocols" tab in the "My Home" area of your eIRB account
and click on your study.
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My study was submitted and disppeared from my eIRB inbox. Where is it?
Your eIRB inbox only contains the items that require an action on
your behalf. If your study was submitted it can be found under the "Protocols"
tab in the "My Home" area of your eIRB account.
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Why don't I have an OK button on the "Personnel Selection" window?
The problem most commonly occurs when your screen resolution is very
low and the browser window is too large to fit the screen. In order
to resolve the problem please maximize your browser window and scroll
down to the end of the page where the OK button is located.
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I receive an error when clicking on the OK button on the "Personnel
Selection" window. What am I doing wrong?
eIRB errors most commonly occur when a required question has not
been answered. On the "Personnel Selection" window it is most likely
that you have not answered one or both of the read and edit rights questions.
Please be sure to answer all required questions, usually indicated by
a red asterisk, before clicking OK or Continue.
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I keep getting an error during registration but I have entered all my information
correctly?
Please double-check all the information you have entered. It is also
important that you enter your name exactly as it appears in the OHSU
HR records and in certain cases HR will have your middle name as your
firstname. Another possibility is that your account was already created,
in which case please contact ORIO at (503) 494-7887
or at irbinbox@ohsu.edu in order to obtain
your eIRB username and password.
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How do I know which IRB Analysts are working on my study?
When you open your study you will see to which board your study was assigned to. Please call
ORIO directly at (503) 494-7887 in order
inquire which IRB Analysts are members of your study's board number.
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I have accidentally answered a radio button. Can I unanswer it?
Please click on the "Clear" link located below or next
to the radio button options.
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- We have revised our IRQ/CRQ and our
PI would like to resubmit it back to the IRB. How can this be done?
Once the PI has logged in to their eIRB account and opened the study/continuing review,
he or she, depending on the status of the study or continuing review,
can use the "Resubmit" or the "Review Requested Changes" available action.
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What do I do if I have accidentally answered Yes to the hard
copy documents question?
Please contact the ORIO office at (503) 494-7887. IRB Analysts and IRB Staff have the
ability to push your study/continuing review out of "Documents Pending" status to the next review
state.
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Is there an eIRB manual and if there is how can I obtain one?
You can download the eIRB User Manual at
http://www.ohsu.edu/research/rda/eirb/#manual.
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How do I know if a study is in "my court" or if it's being reviewed at the IRB?
Once you have logged in to your eIRB account please click on the "My Home" link located in the
upper right section of the page. Any items located in your eIRB inbox require an action on your behalf.
Once you have submitted your study it will disappear from your eIRB inbox and can be found under your
"Protocols" tab. You can also determine the progress of the review process by checking the status of your study.
If you are uncertain what the status of a study means please contact ORIO at
(503) 494-7887 or irbinbox@ohsu.edu.
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Why is the hard-copy PPQ required to be submitted to the ORIO
in order to have my study processed? I thought that the eIRB was a totally paperless
process?
The PPQ and the HIPAA Waiver of Authorization require signatures and must be submitted
as hard-copies.
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When/Will electronic signatures be accepted or integrated through the eIRB system?
Electronic signatures are already a crucial part of the eIRB system.
The eIRB validates your authentication credentials and based upon your
role in the eIRB system determines which available actions you will
have which in the real world translates for instance to only the PI
being able to submit a study to the IRB for review. Submitting of a
study, in this example, is the electronic equivalent of a paper signature.
Because certain documents, such as the PPQ or the HIPAA Waiver of Authorization,
still require a paper signature, the eIRB cannot implement an exclusively
electronic review process yet.
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Do I need to fill out a Clinical Billing Schedule?
It depends on the study. The Clinical Billing Schedule must be completed
and submitted with the Initial Review Questionnaire (IRQ) if the protocol
requires the subjects to undergo any clinical procedures. A clinical
procedure is defined as any procedure, test, or exam performed by a
licensed practitioner (including: blood draws, imaging procedures, genetic
tests for clinical purposes run in a CLIA-approved lab, non-invasive
exams and dental work). If all services (standard of care and study-related)
will be billed to sponsor, check the box and disregard the table. Otherwise,
standard care services that will be billed to the subject or his/her
insurance should be listed in the upper section of the table. Research-related
services should be listed in the lower section of the table.
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Who is required to be listed on the electronic IRQ?
A common misconception is that only investigators who will be accessing
the eIRB need to be listed on the electronic IRQ. This is not true.
All study staff members who are reasonably engaged in the design, conduct
or analysis of the study should be listed on the electronic IRQ. Study
staff must be registered with the eIRB before the system will allow
them to be listed.
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Do all the individuals listed on the electronic IRQ have to be listed on the consent form?
No. It is not an IRB requirement to list the entire study staff
on the consent form. At minimum, the PI must be listed on the consent
form. Beyond that, we suggest no more than 5 of the people the subject
is most likely to encounter during the conduct of the study. The IRB
will accept as many names as you choose to put on the consent, or as
many as your sponsor requires. Some industry sponsors prefer that only
investigators who have filed the FDA Form 1572 be listed on the consent
form. This is acceptable.
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- My sponsor will not accept
the approval memo that was generated through the system because the
Chair did not sign the memo. Will the IRB be able to print the approval
memo and have it signed so my sponsor can be satisfied?
Yes, this can be done on an occasional basis. There are no federal
or state regulations that require the signature of the IRB Chair on
IRB approval memos. The eIRB system does not utilize electronic signatures.
Role-based access to the eIRB system ensures that only the IRB Chair
can issue an IRB approval memo. The ORIO hopes that in time, industry
sponsors come to accept IRB approval memos without the IRB Chair's signature.
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Which browsers does the eIRB support?
Please check the list of supported browsers.
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How can I change my name in the eIRB?
If your name is misspelled or otherwise incorrect in the eIRB please e-mail us at
irbinbox@ohsu.edu and we will contact HR in order for HR to correct
your name in the HR database. The eIRB will then automatically import the corrected name over night.
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If you have not found the answer to your question please contact ORIO at (503) 494-7887 or at irbinbox@ohsu.edu.
Thank you for using the eIRB!
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