May 2009 Announcements
- Immediately Start Using the New Unanticipated Problems Reporting System
- IRB Forms - Additional Revisions
- IRB Manager - Electronic System
- AAHRPP Update
- CITI - New Educational Requirements
New Reporting Requirements for Unanticipated Problems
Please immediately start using the new reporting
system and new reporting forms for unanticipated problems, adverse
events, IND safety reports and other issues related to the safety of
To learn more about
the new reporting requirements, please go the HRPP website and choose
the following pages under the IRB tab:
1) Unanticipated Problems and Other Events Requiring Prompt Reporting; and
2) Submission of IND Safety Reports. Click Here
There are three new reporting forms that can be downloaded from the Forms page. Instructions are included on each form.
The new reporting
requirements may be confusing to many of you. If you have not already
done so, we recommend that each department or section schedule an
in-service with HRPP to go over the new requirements and forms.
Please contact Aliese Seawright at email@example.com or 318 675-7811; or Donna Singleton at Dsingl1@lsuhsc.edu or 318 675-5925
IRB Forms - Updates and Edits
Several of the new IRB forms have undergone
additional edits or revisions. Your feedback has been very helpful with
this process. Please continue to let us know if you are experiencing
any problems with the forms. You will be required to start using them
by June 1, 2009.
recommend that each department or section schedule an in-service with
HRPP to go over the new forms. Please contact Aliese Seawright at firstname.lastname@example.org or 318.675.7811.
A web-based electronic information management
system called IRB Manager is currently under development and should
become operational during the fall of 2009. This internet accessed
system should streamline the protocol submission process and reduce the
amount of "paper" copies currently required by the IRB.
IRB Manager will provide the technology to help us
control and organize more information in less time. We will keep you
informed of our progress with this new system.
AAHRPP Site Visit
HRPP would like to thank everyone who was involved
with the AAHRPP site visit for their participation. Your cooperation
and support produced a positive response from the site team. The final
accreditation status is pending and will be determined at the June
AAHRPP council meeting.
Collaborative Institutional Training Initiative (CITI)
We are pleased to see that so many of you have
registered and completed your new CITI educational requirements. CITI
has replaced the Research Compliance Education Course that was
administrated by the Compliance Office.
If you are an
investigator, coordinator, faculty, staff or student involved in the
conduct of human subjects research, we ask that you begin your CITI
training and education at this time. It will be necessary for you to
complete all the required courses by August 1, 2009.
Before you begin your
CITI courses you must determine your "learner group" and register with
the CTO office. To learn more about CITI and your learner group
please go to the HRPP website and choose Mandatory Education
Requirements. A link to CTO registration is included on the same web
page. Click Here.
completed for another institution within the last two years may be
transferrable. You will need to go back to the CITI website and choose
Louisiana State University Health Sciences Center - Shreveport as an
affiliate institution. Please review the LSUHSC-S course requirements
to make sure that you have completed all the courses for your learner