Investigator Requirements over the Life of a Protocol
Submit protocol to CRIMSON and ARIA (and if necessary VA R&D and
VA IRB) Follow all rules and regulations of the governing
institution.
Attend CRSC Protocol Implementation Meeting Once
your protocol has been approved by the CRSC Scientific Advisory Committee
(SAC), the UAMS IRB, and if needed, the VA R & D, you are ready to begin
enrolling study subjects in your protocol. Contact the CRSC Nurse Manager to
schedule an implementation meeting. The purpose of the meeting is to work
out all the details of how the protocol will proceed on the floor with the
CRSC staff. The PI of the study must attend the implementation meeting.
Participate in Annual Review Every CRSC protocol is
reviewed annually by the SAC to ensure that the protocol is proceeding
toward the investigator's stated recruitment goals. In addition, this
information is required for the NIH annual Clinical Translational Science
Award report. The SAC may consider increasing or decreasing support based on
the degree to which progress of the protocol contributes to the CRSC goals.
Update CV Annually Each year, the CRSC is required
to complete an annual progress report for the NIH. To complete the report,
we must have from each PI a list of publications within the past year
(published and "in press"), a short protocol progress report, and a current
copy the investigator's NIH Biosketch/Other Support (including funding
sources).
Update Publications List Quarterly The NIH uses the
number of publications resulting from CRSC studies as an important metric for
measuring the utilization of the CRSC. Because of the importance of that
metric to our continued funding, the Dean of the College of Medicine has
requested a quarterly report of publications by CRSC investigators
(submitted, accepted, in press, or published). Once available, please
forward the PDF or MS Word copy of the publication to the CRSC.
Adhere to Data and Safety Monitoring Plan (DSMP)
Every CRSC protocol must have a Data and Safety Monitoring Plan (DSMP). The
plan must be approved by the SAC as a part of the SAC application process.
The SAC relies upon the RSA to examine DSMPs for form and content. Protocols
are chosen at random to audit whether the PI is adhering to the approved
DSMP and that the PI is appropriately documenting that adherence. These
audits include such items as assessment and adherence to inclusion/exclusion
criteria, presence of the proper consent form, documentation of PI review of
safety data as described in the DSMP, and proper reporting of serious
adverse events (SAEs) and adverse events (AEs).
Cite CRSC (Award Number U54 RR025209) in all publications
Remember to always cite the CRSC in your publications resulting
from studies that received any support from any of the CRSC resources. We
suggest, "We acknowledge the support of the University of Arkansas for
Medical Sciences' Clinical Research Services Core, Award Number U54 RR025209 from
the NCRR." Thank you for remembering to cite us! 8. Serve on the SAC
Scientific Reviewers Reserve Group
Serve on the SAC Scientific Reviewers Reserve Group
All studies will undergo review, including scientific review. If an in depth
review is required a member of the SAC Scientific Reviewers Reserve Group
will be utilized. This group is made up of all Pathfinders, Rainmakers, TRI
and CRSC users. Utilizing this group will assure that the CRSC will have a
robust supply of reviewers from which to choose and each proposal will be
reviewed appropriately. Reviewers will only need to meet with the SAC when
they have reviewed a protocol.
UAMS Translational Research Institute 4301 W. Markham #Slot 577, Little Rock, AR 72205, 501-614-2287
