Regulatory Support , Advocacy and Bioethics Core (RSAB)

Other Resources

What Every Study Coordinator Wants to Know

The CCTS, with the help of the Clinical Research Forum, has posted a resource list that provides information on how research works at UIC. The links offer both national and local standards, tools and contacts, to help answer your questions as you plan and conduct your research.
For more information, Click here

Accessing research services at the University of Illinois Hospital

Research Services:
Obtaining Research services within University of Illinois Hospital

Case Report Form


RSAB collaborated with members of the OVCR Quality Improvement Program to develop a set of standard case report forms that are now available on the OVCR website. The forms should be useful for any investigator initiated clinical trials and can be customized to an individual study.

A Case report form (CRF) is a printed, optical, or electronic document designed to record all protocol-required information on each subject in a clinical research study. The CRF facilitates complete and standardized data collection that promotes efficient processing, analysis, and reporting of information, as well as exchange of data across sites and to the Sponsor/Principal Investigator/Data Coordinating Center.

To learn more, visit: http://go.uic.edu/CaseReportForms.

Helpful sites from the Office for the Protection of Research Subjects

OPRS Home page:
http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/index.shtml

OPRS Getting Started Page:
http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/getting_started.shtml

OPRS Frequently Asked Questions: The Office for the Protection of Research Subjects has posted "FAQs" that can help you as you develop your research. The FAQs are grouped into the following categories:
1. General Human Subjects Research FAQs
2. Community-Based Human Subjects Research FAQs
3. Appendix M Research Data Security Form-specific questions FAQs
4. General Research Data Security Questions FAQs

Read more at: http://go.uic.edu/IRB_FAQs.

OPRS Tip Sheets: The OPRS website has posted "Tip sheets" which serve as reference materials for IRB members and OPRS staff during review for regulatory guidance, as appropriate. These provide a restatement of some frequently used regulations related to human subjects protection. This can be extremely useful when a researcher is interested in understanding the "whys" behind the questions a reviewer may ask. Click here for more information.

Open Research Projects at UIC: The OPRS website includes a directory of research studies at UIC that are actively enrolling subjects. The listing will help guide individuals who are interested in participating in clinical or social-behavioral research at UIC. The directory listing will contain the protocol title, enrollment contact information, and three keywords. To visit website for the directory click here.

If you have a research study that you would like to have listed on the website, please fill out the form entitled "Type 12: Research Directory Listing" here and email it to uicirb@uic.edu with the subject heading RESEARCH DIRECTORY. OPRS will verify the information on the form and will post the study to the directory. It is the responsibility of the PI to inform OPRS when enrollment is completed, so the study can be removed from the registry. PIs will also have the option of listing their study by checking a box on the new initial and continuing IRB application forms.

Lay Language Link: Are you trying to translate language from your research protocol into lay language for an IRB submission?  The link below goes to a site at the University of Michigan where you will find a Simplification Guide to Medical Terms that has suggestions for common medical terms that may need translation.  http://www.med.umich.edu/irbmed/guidance/guide.htm

OVCR Quality Improvement Program Toolbox has templates you can use : Are you the PI or coordinator of an Investigator-Initiated research study?  If so, take a look at the OVCR website for their Quality Improvement Program. Ensuring that research studies comply with the principles of Good Clinical Practice and applicable government regulations requires planning and documentation.  In industry-sponsored studies, appropriate documentation forms may be provided.  PIs of Investigator-Initiated studies sometimes struggle with documentation.  The OVCR Quality Improvement Program has created a good Toolbox of standard tracking forms that will help you capture essential information in an organized fashion.
http://tigger.uic.edu/depts/ovcr/research/QIP/toolbox.shtml

Educational opportunities

RSAB staff members are available to speak about the Core to your department or research program, on request.

Need a Data and Safety Monitoring Board?

A data and safety monitoring board (DSMB) or data monitoring committee (DMC) is a group of independent experts that review the ongoing conduct of a clinical trial to ensure continuing patient safety as well as the validity and scientific merit of the trial. While every study needs a Data Safety Monitoring Plan (DSMP), not every study needs a DSMB. More information about DSMBs may be found at http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/policies/0272.pdf .

If you believe that a DSMB is required for your clinical research project, please contact the CCTS Regulatory Support , Advocacy and Bioethics Core. Our Research Participant Advocate, Burton Andersen can help in deciding the need for a board, the board size and composition, and can recommend potential members. Please complete the application form and under "Services Requested", check "Research Participant Safety",and choose "DMC Review" or "DSMP Review". If you have any questions, please contact our Investigator Interface Coordinator, Lauren Walsh (laurenw@uic.edu, or 312-413-7316).

ClinicalTrials.gov

ClinicalTrials.gov is a national registry and results database of publicly and privately supported clinical trials conducted in the USA and around the world. Certain types of trials are required by law to be registered when they begin, and the information updated throughout the study. For further information and guidance about which clinical trials should be registered, who is responsible for registering the trial, the registration process, or the results reporting requirements refer to:

For Questions or Services

If you have general questions, you can contact Lauren Walsh (laurenw@uic.edu).

BILLING INFORMATION:

Initial consultation with an RSAB Coordinator to discuss potential services is free of charge. Fees for RSAB services may be subsidized based on project funding source. Please contact Andrea Carnegie at acarnegi@uic.edu for details.