RSAB Links
Services Provided
The RSAB offers the following services:
1. Concierge services that include a coordinated and simplified approach to regulatory compliance tasks:
- Protocol Development
- IRB Submissions
- Data & Safety Monitoring Plan (DSMP)
- Data & Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) Management & Oversight
- IND/IDE Submission
- IND/IDE Report Submission Assistance
- Adverse Experience Reporting to the IRB and External Agencies
- Good Clinical Practice (GCP) and Study Start-up Education
- Consultation
- Initial Clinical trial registration
- Certificates of Confidentiality
- Conflict of Interest
- Research Ethics Consultation
These and other services are offered individually or as a package. For a detailed service list, click the button below.
2. Research Participant Advocacy
- Consult on subject safety issues
- Complete a risk assessment
- Evaluate data safety monitoring plans, data monitoring committees, and safety reports
- Evaluate adverse events (AEs)
- Evaluate unanticipated problems involving risks to subjects
3. Education and training programs on regulatory topics
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Core members are available to speak to departments and research programs about the regulatory core services and regulatory requirements.
For Questions or Services
Consultation is available by appointment. Kindly complete the service request form that can be accessed by clicking on the 'RSAB Service Request' button on the left side of this page.
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.
Protocol Development
We will help turn your grant into a protocol or modify your existing protocol for regulatory submissions.
Service plan: A la carte
Back to TopIRB Submissions
On behalf of the investigator, we will complete any type of IRB application including Western IRB Applications, specialty committees such as the Cancer Center Protocol Review Committee, VA submissions, and Radiation Safety and Biosafety committees; write the consent form, HIPAA authorization form, Appendices, DSMP & other IRB related documents; work with the investigator to respond to IRB modification requests in order to obtain full IRB approval.
Service Plan: Platinum, Gold, Silver, A la carte
Back to TopData & Safety Monitoring Plan (DSMP)
Our staff will help you draft the DSMPs for your grant or protocol should your study require them.
Service Plan: A la carte
Back to TopData & Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) Management & Oversight
We will conduct a risk assessment. We will help you decide if your study needs a DSMB. We will help set up the structure of the DSMP and evaluate data safety monitoring plans, data monitoring committees, and safety reports.
Service Plan: A la carte
Back to TopIND/IDE Submission
We will help you decide if your study needs an IND or an IDE and if one is needed we can help you prepare and submit the information required for the application(s).
Service Plan: Platinum, Gold, A la carte
Back to TopIND/IDE Report Submission Assistance
We will help investigators collect the information necessary to submit an Annual Report, an Amendment to the IND/IDE, a Report of New Investigators, or Protocol Amendment to FDA.
Service Plan: A la carte
Back to TopAdverse Experience Reporting to the IRB and External Agencies
We will help you evaluate adverse events (AEs) and serious adverse events (SAEs) in preparation for you making timely & complete reports of AEs/SAEs to the FDA, the IRB & other oversight agencies.
Service Plan: A la carte
Back to TopGood Clinical Practice (GCP) and Study Start-up Education
We provide education sessions on the practical application of Good Clinical Practice activities for you & your research staff. We can also provide one-on-one consultations to help study staff initiate/ transition studies with GCP in mind.
Service Plan: Free
Back to TopConsultation
We can provide guidance on IRB requirements and best practices. We also provide guidance on: genetic research, repositories, data banks, and vulnerable populations.
Service Plan: Free
Back to TopInitial Clinical trial registration
We can help you with ClinTrials.gov registration to ensure you are in compliance with this requirement for publication.
Service Plan: A la carte
Back to TopCertificates of Confidentiality
We can complete the COC application, collect the required documents and submit to NIH
Service Plan: A la carte
Back to TopConflict of Interest
We will assist you with preparation of a Statement of Explanation and Management (SEAM) if necessary.
Service Plan: A la carte
Back to TopResearch Ethics Consultation
Investigator may request a Research Ethics Consultation (REC) at any stage of a study. Also, the IRB may request REC consultation.
Service Plan: Free
Back to Top