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Research Coordinator Network

 

 

What does it take to be a Research Coordinator? In many settings, the REAL work of implementing a research study is delegated to a Research Coordinator. This means coordinators are often responsible for grants and budgets, knowing Federal regulations, preparing regulatory submissions, writing study protocols, creating data collection forms and managing databases, developing recruiting plans, supervising staff, and a multitude of other duties. Many people who have taken on this role know all too well the difficulties of learning how to do it 'on-the-job'! Little formal preparation is available to provide coordinators with the skills necessary to be successful in this very important role.

We hope that this webpage and the upcoming educational opportunities both on our campus and UAMS will give you a helpful and easy-to-find resource for all your needs.

 

 
QUICKLINKS
 
Research Coordinator Meetings and Minutes
Educational Opportunities
Compliance Corner
Regulatory Affairs Hotline
New/Revised Policies
Common Questions and Answers
Helpful Links
Guidebook Homepage
 
 

CONTINUING REVIEW IN ARIA

Learn how to complete your continuing review in ARIA by watching how-to videos at http://achri.archildrens.org/guidebook/ARIAcrr.html

 

THE RESEARCH COORDINATOR DATABASE
Have you ever had a problem but didn't know who to contact? Or have you ever just wanted to reach out to other clinical research coordinators? Check out this list of research coordinators on the ACH/ACHRI campus.
Click Here to see the list of coordinators who have signed up so far. Feel free to contact any of these coordinators with questions, or issues in your practice. Those who have answered "Yes" to the questions area are willing to help new coordinators.
If you have any questions/problems/additions to this list, please contact Margie Brackeen.
 
COORDINATOR MEETINGS AND MINUTES
 
 
October 2009 Coordinator Meeting

Date: October 9 , 2009

Time: 12:00pm-1:00pm
Place: East Campus 49
Lunch will be provided for the first 30 attendees. This quarterly meeting gives research coordinators across campus a chance to assemble, network, and ask questions of ACHRI related to their projects and issues within the ACH/ACHRI research community. Click Here for the Agenda of this meeting.
 

Upcoming Meetings for 2009

 
 
Minutes of Previous Meetings:
March 2008 Coordinator Meeting Minutes
November 2007 Coordinator Meeting Minutes
June 2007 Coordinator Meeting Minutes
April 2007 Coordinator Meeting Minutes
 
 
EDUCATIONAL OPPORTUNITIES -- Click Here to Visit Our New Calendar Page!
 
 
   
 
COMPLIANCE CORNER
   

 

Review your clinicaltrials.gov submission every six months!

Do you have a study on clinicaltrials.gov?  Take a moment today to put a reminder in your calendar to check your submission every six months.  Not only is this required, but just good practice.   Protocol records for active trials should be reviewed or modified as needed at least every six months.  Pay special attention to the recruiting status and contact information as the accuracy and timeliness of this information is extremely important to patients and health care professionals.  Update the record’s verification date (via the Edit Protocol screen) to confirm the record has been reviewed.

 
 
REGULATORY AFFAIRS HOTLINE
 

Arkansas Children's Hospital has instituted a Compliance Hotline, for use by anyone who knows of, or suspects any illegal, unethical, or questionable activity.

The Compliance Hotline is intended to provide a private means to report issues that are considered to be of importance, especially if an appropriate means to report something is unknown. Callers to the Compliance Hotline will not be retaliated against by their managers or supervisors for making calls to the Compliance Hotline. All calls to the Compliance Hotline are confidential and private.

The Compliance Hotline is operated by an outside vendor, located out of state. This company specializes in healthcare related compliance issues, and the telephone operators have been trained to receive Hotline calls. The Compliance Hotline is available 24 hours a day, seven days a week. All calls will be answered by a live person. Calls are not recorded and are not able to be traced. Callers have the option to remain anonymous. If the caller remains anonymous, they will be given a numeric code so they may call back and ask for follow up. Callers will be guided through the call and prompted by appropriate questions from the operator. It is important that the caller provide as much detail as possible. The caller will be given a date on which they can call back and receive a follow up report. Once the call is completed, a report will be generated and sent to the ACH Corporate Compliance Officer or Director of Corporate Compliance.

All reports will be investigated internally, and the findings will be reported back to the Compliance Hotline. Callers are urged to call back for follow up, because in the event more information is required, this will be an opportunity for the caller to provide those details.

The phone number to the Compliance Hotline is 1-877-384-4275. All calls are free.

 
 
 
NEW AND REVISED POLICIES AND DIRECTIVES
 

Arkansas Children's Hospital Research Institute (ACHRI) Policies

Research Study Documentation: Informed Consent Policy

 
Clinical Trials Policy
 
Non English Speaking Subject Recruitment & Informed Consent Policy
 
Informed Consent for Foster Children
 

Maximum Allowable Single Blood Draw Volumes Chart

 
All ACHRI Policies
 
UAMS Institutional Review Board Policies
 
New Institutional Review Board (IRB) Policy Changes and Updates
 
 
 
RECENT QUESTIONS AND ANSWERS
 
Q: I heard that the mandatory training for human subject protections has changed, how do I get to the new training?
A. We have changed the course to the CITI program. Go to www.citiprogram.org and register. You will only need to do this once your current training has expired.
 
Q. What score do I need to have to pass the CITI test?
A. In order to pass the test and receive a certificate you will need to have 100% on all tests. Don't worry, you can re-take the tests as many times as you need in order to get the 100%.
 

Q. Do I still need to take the HIPAA for research course?

A. No, the HIPAA for research course is included in the new CITI course, so you will only need one certificate.
 
Q. How do I find out more about the CITI program?
A. You can contact Margie Brackeen, go to the CITI site, or you can view the PowerPoint presentation from the CITI informational sessions.
 
Q. Is it mandatory that I take the Responsible Conduct of Research Course on CITI?
A. No, the only mandatory courses are the Biomedical and Social/Behavioral. You must choose one of these based on the type of research you perform.
 
 
HELPFUL LINKS
 
UAMS Research Support Center
 
The Society of Clinical Research Associates (SoCRA)
 
The Association of Clinical Research Professionals (ACRP)
 
ACHRI Clinical Trials Forms (Website Form, PCRU Usage, etc)
 
Clinic Director's Chart
 
 
CONTACT US
 
Click on each staff member below for their administrative profile:
 
Tanda Grisham, Esq
Margie Brackeen
Janet Storment, RN
Amanda Holloway
 
 
 
 
Guidebook Homepage
 

Arkansas Children's Hospital Research Institute
1120 Marshall Street
Little Rock, AR 72202
(501) 364-7373
Fax (501) 364-2705

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