We encourage investigators to meet with our staff at
the beginning of protocol or grant development to determine what ways we may
assist. Many times investigators are unaware of the many ways we can help.
Submission of protocols is an easy process. Simply
check "YES" to this question in ARIA: "Will this Research be Conducted in
Conjunction with CRC?" then finish inputting your protocol in ARIA. ARIA
will ask you to upload the CRC Resource Request Form. This is a short form
that will enable our staff to review resource needs and allocations. It is
found at
CRC Resource Request Form in PDF or
CRC Resource Request Form in Word. When the investigator submits the
protocol to ARIA, ARIA notifies the CCTR Navigator (Angela Smith) and CRC
Nurse Manager (Cynthia Witkowski). Please call (526-7984) or email (ClinicalResearchCenter@uams.edu)
the CRC to assure notification.
The Center for Clinical and Translational Research
Scientific Advisory Committee (SAC) will review protocols at least once each
month. Please submitprotocols to the CCTR by the first Monday of each
month. Once the CCTR receives your protocol submission, the Administrative
Team reviews your protocol and the protocol will be placed on the SAC’s
agenda. Some studies only need the Administrative Team's approval. At the
same time, the UAMS IRB Committee will review the protocol according to
their time frames. SAC reviewers have access to ARIA documents so they will
see changes made; thus, an investigator needs only to make changes in ARIA
for both committees. The Principal Investigator (PI) is invited to attend
the SAC meeting when the protocol is being considered to answer questions
and provide supporting detail.
Following the SAC meeting, approval and stipulation letters are sent to
the PI by the CCTR. Special provisions exist for
expedited review and administrative approval
of a protocol.
The protocol does not have to have
IRB approval before being submitted to
the SAC. However, it must have approval from all oversight bodies prior to
its activation within the CCTR. Some investigators require VA R&D and VA IRB
approval. Please contact the CCTR if you are not sure which approvals you
will require. Following approval, the PI should schedule an
implementation meeting as required for
protocol activation.
Please contact the CCTR for assistance and answers to any questions
regarding submission of a protocol, the approval process, or the steps to
protocol activation. The implementation process can be viewed in flow sheet
form by clicking a viewing option:
(PDF)
or (Word).
Once the protocol is activated, the PI will
be responsible for a number of requirements over the life of a protocol.
Those responsibilities can be viewed by clicking