The CAER system has been live in production since April 2003. Below
we have prepared answers to some frequently asked questions regarding
the guidelines on the reporting of adverse events and the CAER system.
If you have a question that is not listed below, please call the IRB office at 202.687.6553 or send an email to caer@georgetown.edu
- Who has access to CAER?
The CAER system is Georgetown University NetID-enabled. There are
two prerequisites to using the CAER system: a) you must have GU NetID
credentials, and 2) you must have gone through a CAER orientation
session.
- What is a NetID and how should I know if I have one?
NetIDs are generated automatically for every employee, student and
alumnus entered in Genesys, SIS, or the alumni database. All Georgetown
University or Georgetown University Hospital employees should have
a NetID. For Georgetown University employees, the NetID is also the
alias that goes before the '@georgetown.edu' domain of their email
address. Georgetown University Hospital employees have a NetID, but
may not know it. If unsure, you can find your NetID by checking the
Directory
page and typing your name in the search field. If you are, in fact,
in the system, your name and NetID will be displayed.
- I am not a Georgetown University or Georgetown University
Hospital employee. How do I obtain a NetID?
The IRB office can apply for a NetID on your behalf. In order to
be entered into the Genesys system, you will have to download the
Affiliated Non-Employee Transaction Form
(MSWord format) and send it to the IRB office. The IRB office will
notify you once your NetID has been generated.
- I have obtained my NetID, how do I obtain a password?
Please consult the NetID password page at http://uis.georgetown.edu/netid/reset.html.
- I have full GU NetID credentials and I have gone
through the CAER orientation. What is the web address of CAER?
The web address of CAER is https://sae.georgetown.edu/caer/
- What type of events should I report to the IRB using
the CAER system?
a) Internal unanticipated and serious adverse events, b) external
unexpected adverse events, c) external expected adverse events.
- I have received a case safety report for an external
event that is not suspected to have been caused by the investigational
drug, device, or procedure. Should I report the event to the IRB?
Yes. Each time you are notified of an adverse event by the sponsor,
MedWatch system, or external investigator, you are required to notify
the IRB.
- An internal event has occurred and the PI believes
that the event is not caused by the investigational drug, device,
or procedure. Should I report the event to the IRB?
Yes. Ultimate decisions concerning safety and efficacy are done at
the local IRB level.
- What if I do not have sufficient information to determine
whether a reaction was caused by an investigational drug, device,
or procedure?
The IRB Subcommittee on Adverse Events will review the event and
follow up with you for any additional information to make a determination.
- How do I find out if a case safety report has already
been reported to IRB through the CAER system?
While in the CAER system, from the main page, click on "Search Reports."
In the "Case Safety Report Number" field, type the unique number on
the form >> click the "Search" button.
- Which adverse event reporting policies and procedures
supercede? that of the Georgetown University IRB or the sponsor? Which
do I follow?
You should always follow both the IRB and the sponsors requirements.
- A human research subject is off the study but has experienced
an adverse reaction. Should I report the event to the IRB?
Please contact the IRB subcommittee on adverse event by sending an
email to caer@georgetown.edu.
The answer to this question may vary case by case.
- A human research subject that is currently enrolled
in a study, conducted at Georgetown University [Internal event], has
been hospitalized. The PI believes the hospitalization is not related
to the investigational drug, device, or procedure. Should I report
the event to the IRB?
Subject hospitalization is defined by FDA and NIH guidelines as reportable
event.
- A case safety report has been received from the sponsor
indicating that a human research subject that is currently enrolled
in a study, outside Georgetown University [external event], has been
hospitalized. The sponsor and/or the site PI believe the hospitalization
is not related to the investigational drug, device, or procedure.
Should I report the event to the IRB?
Subject hospitalization is defined by FDA and NIH guidelines as reportable
event.
- I have received a report from the sponsor, advising
of an adverse event that occured in an animal research study believed
to be related to an investigation drug, device, or procedure. Should
I report the event to the IRB?
Please contact the IRB subcommittee on adverse event by sending an
email to caer@georgetown.edu.
The answer to this question may vary case by case.
- I have received a follow up for an event that is not
in the CAER system. What should I do?
Please treat the case safety report as original. All other follow
ups received for this safety report can then be added in the CAER
system using the "Amend" function.
- I have received a case safety report for a multi-site
trial which has been closed at Georgetown University. Should I report
the event to the IRB?
Please contact the IRB subcommittee on adverse event by sending an
email to caer@georgetown.edu.
The answer to this question may vary case by case.
- I don't have access to a computer and need to submit
an expedited report to the IRB. May I use the paper-based AE form?
Yes.
- Where do I find new IRB guidelines on adverse event
reporting?
Stay tuned.
- Can I associate an adverse event to multiple protocols?
Yes. From the Protocol select list, please hold the CTRL key and
click on the applicable protocols.
- Can a report that has already been submitted to IRB
as a final report be modified or updated with additional information?
The report that has been submitted as final cannot be modified. However,
you may use the "Amend" function to append additional information
to the report.
