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| 1.
Submit protocol to
CRIMSON and ARIA
(and if necessary VA R&D and VA IRB) |
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Follow all rules and regulations of the governing institution. |
| 2.
Attend CRC Protocol
Implementation Meeting |
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Once
your protocol has been approved by the CRC 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 CRC 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 CRC staff. The PI of the study
must attend the implementation meeting. |
| 3.
Participate in Annual Review |
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Every CRC 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 CRC goals. |
| 4. Update
CV Annually |
| |
Each
year, the CRC 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). |
| 5. Update
Publications List Quarterly |
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The
NIH uses the number of publications resulting from CRC studies as an
important metric for measuring the utilization of the CRC. 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 CRC
investigators (submitted, accepted, in press, or published). Once available,
please forward the PDF or MS Word copy of the publication to the CRC.
|
| 6. Adhere
to Data and Safety Monitoring Plan
(DSMP) |
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Every CRC 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).
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| 7. Cite
CRC (Award Number U54 RR025209) in all publications |
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Remember to always cite
the CRC in your publications resulting from studies that received any
support from any of the CRC resources. We suggest, "We acknowledge the
support of the University of Arkansas for Medical Sciences' Clinical
Research Center, Award Number U54 RR025209 from the NCRR." Thank you for remembering to
cite us! |
| 8.
Serve on the SAC
Scientific Reviewers Reserve Group |
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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, CCTR and CRC
users. Utilizing this group will assure that the CRC 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.
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