1. Before you can conduct clinical research on the UAMS campus or any affiliated campus that uses the UAMS IRB, you must complete Human Subjects Protection and HIPAA for Research training.

• Go to www.citiprogram.org and select University of Arkansas for Medical Sciences
• Create your own user name and password.
• Fill in your contact information.
• On the Learner Group page, select either Biomedical Research (if your study involves drugs or devices) or Social/ Behavioral Research. You do not have to take any of the other optional courses, but you may find them helpful. 
• HIPAA for Research is incorporated into both the Biomedical and the Social/Behavioral courses.
• All modules will require you to score 100% on each quiz. You can take the quizzes as many times as necessary.
• Your certification will be valid for 2 years.
• If you need assistance with this process, call Crystal Hunnicutt - 526-6879.

2. The next step is getting ARIA access. There are three different modules in ARIA: the IRB module, the CRIMSON module, and the Projects module. ARIA is the Automated Research Information Administrator. All studies that go to the UAMS IRB must be entered into ARIA.  To obtain an ARIA user name and password, you will need to fax your CITI completion report to Allison Streepey at the IRB (Fax: 686-7265/Phone: 296-1281) and request access to ARIA.

• IRB Module - All IRB submissions and correspondence are accomplished through the IRB Module. This module greatly reduces the time and paperwork involved in IRB submission. For ARIA IRB module training, contact Connie Price - 526-5494.

• CRIMSON Module (Clinical Research Information Management System) -  All clinical research that will be performed on the UAMS campus now has to be entered into the CRIMSON module. In order to use this module, you will need to be trained. Contact Julia Washam - 686-8572. The key features CRIMSON offers are:

• Electronic submission and approval of clinical research budgets

• Coverage reviews when appropriate

• Accurate assignment of research and clinical charges to appropriate accounts

• Integration with the ARIA IRB module

• New modules that permit electronic submission of other required reviews

• Contract review and approval

• Electronic routing and signoff

• Projects Module - The Projects module of ARIA is the portal for review and approval of all grant proposals for UAMS. Each new or continuation proposal must be entered into the projects module and receive department, college, and institutional approval before being submitted to the funding agency.  The Projects module allows department, division, and college administrators to review proposals via the web.  This module is also the repository for the official grant file for each pending and awarded project. Contact Connie Price - 526-5494 for more information and training.

3. The Research Support Center can assist you in many areas of your research.

• Preparation of documents to be submitted through CRIMSON (Protocol, Informed Consent, Case Report Forms): Ricki Helm, PhD - 686-5961.

• Regulatory Reviews and IND/IDE: Carole Hamon - 526-7437

• ClinicalTrials.gov Entry: Lyndsey Avery - 686-5190

• GMP/GLP/GTP Quality Assurance: Raymond Anderson, PhD - 526-6878

• IND/IDE Monitoring: Tracie Baker - 686-7093

• Budget/Coverage: Julia Washam - 686-8572

• Education: Crystal Hunnicutt - 526-6879

4. Contact information for UAMS committees/offices that may review your research:

• Bio-Safety Committee: Chair - Lee Soderberg, PhD - 686-6368

• Biostatistics: Director - Paula Roberson, PhD - 526-6726

• Clinical Research Data Management (CRDM): Director -

• Clinical Research Center (CRC): Director - Phil A. Kern, MD, 501-526-6802

• Contract / Legal Review - Director: Suzanne Leslie, 364-7510; Dori Wong, JD - 526-6247

• Division of Laboratory Animal Medicine (DLAM): Director - Mildred Randolph, DVM - 686-5255; Joe Underwood - 686-8846

• Data Safety Monitoring Board (DSMB): Don Mock, MD, PhD - 526-4207

• Environmental Health and Safety - Carol Price - 686-5299

• Grants and Cost Accounting: Director: Janet Hopper - 686-6841

• Institutional Review Board (IRB): Director - Pamela (Mo) Valentine - 526-5290

• Institutional Animal Care and Use Committee (IACUC): Director: Max Baker, 686-6244; Linda Laney-Rogers - 686-5347

• Office of Grants and Scientific Publications : Director - Jan Wojcik - 686-6004

• Office of Research and Sponsored Programs (ORSP): Director: Suzanne Alstadt, 526-6940; Contract Review: TBA

• Protocol Review and Monitoring Committee (PRMC): Chair - Anne-Marie Maddox, MD; Assistant - Alice Beard - 296-1505 x1818

• Radiation Safety: Kim Wiebeck - 686-7803

• Office of Research Compliance: Director - Jennifer Sharp, JD - 686-8062

• Research Pharmacy: Director - Jennifer Roberts, PharmD - 686-6246.

5. For studies through Arkansas Children's Hospital Research Institute (ACHRI), go to http://achri.archildrens.org/guidebook/homepage.html.  Contacts at ACHRI are Tanda Grisham, JD - 364-3571 and Margie Brackeen - 364-3586.
    
6. The VA is considered a separate entity from UAMS with its own IRB and policies. For Little Rock and North Little Rock Veteran's Administration (VA) studies, contact Research Administration - 257-4816 or Dr. David Straub - 257-4802.
   
   If you have access to the VA Intranet, you can view their research website at http://vaww.little-rock.med.va.gov/research/Home%20page/index.asp