Regulatory Support Program

The Regulatory Support Program (RSP) is central to expanding regulatory knowledge and support of clinical and translational research at Northwestern University, its hospital affiliates, and the community.  This office provides a range of services and expertise to meet the institutional and external needs of investigators, scholars, and trainees.

Clinical Coordination Services

Services

• Clinical coordination for Phase I-IV studies including data collection and CRF completion, obtaining inform consent, specimen draw/processing, regulatory affairs maintenance, subject recruitment assistance and financial tracking.
• Flexible scheduling to allow for full-time, dedicated research support, part time coordinator assistance, or temporary help.

Benefits

• Trained Experts - Formal training in federal and local regulations governing clinical research, Good Clinical Practices (GCPs), and NMH and NMFF requirements is required for all NUCATS coordinators.  This knowledge allows them to be immediately productive for your studies.
• Project Management Expertise - NUCATS study coordinators can orchestrate and manage your clinical research projects from study acceptance to study completion.
• Flexibility - You have options of hiring a coordinator should your coordinator take an extended leave of absence.  You can contract to hire a part-time coordinator for a short-term study or a full-time coordinator to manage several studies.  Best of all, you can change the percent effort of coordinator time needed as your study needs change.

Regulatory Affairs

Services

• IRB Submission of new protocols and amendments (e-IRB submission or paper)
• Informed consent preparation and negotiation
• Completion of NMH, Cancer Center VA, GCRC, or RIC submissions
• Preparation of HIPAA compliance documents and authorizations
• Sponsor-required regulatory document completion
• Regulatory binder assembly
• Investigator-initiated IND/IDE application support
• Hourly regulatory support for continuing reviews, revisions, and general regulatory administration

Benefits

• Save Time - Spend your time overseeing the research study and seeing subjects instead of performing administrative tasks.
• Streamline Approval Process - Our Regulatory Affairs Department understands sponsor, IRB, NIH, and FDA approval requirements and follows all regulatory rules, allowing for rapid IRB approval and fewer last-minute surprises.
• Minimize Frustration and Confusion - You'll have a central point of contact for regulatory questions and concerns.

Financial Services

Services

• Budget preparation for clinical trials
• Review of financial section of the clinical trial agreement
• Completion of the OSR-CT form and submission to OSR with regular follow-up
• Negotiation of the study budget with the sponsor
• Cost-can usually be paid for in the budget from sponsor

Consulting Services

• Provide training to a department administrator on the process of creating a clinical trials budget and helpful negotiating points.  Will also explain the process of submitting a contract to OSR.
• Need further assistance with periodic study invoicing or reconciliation? Contact NUCATS about hourly help with overall study financial administration for your projects.  We can also work on the back end to ensure that all revenue has been collected and accounted for on the studies that are ready to be closed out. 

Recruitment Services

Services

• Develop strategic marketing plans
• Create recruitment materials such as print and broadcast advertisements and direct mail pieces 
• Obtain proper IRB approval of recruitment materials
• Telephone, pre-screen and schedule potential subjects

Benefits

• Save Time and Effort by allowing our knowledgeable staff work for you
• Allows your study coordinator and staff to concentrate on the actual study visits
• Hourly rates allow for cost-efficiency

Leadership

The director of the RSP is Lewis J. Smith, MD, a senior NU faculty member with extensive experience as a clinical investigator (leader and participant in NIH, foundation, and industry-sponsored patient-oriented research projects), IRB panel member and chair, speaker at national and regional forums on human subject protections, holder of two investigator INDs, developer and director of the Master of Science in Clinical Investigation (MSCI) program at NU and research subject advocate for the GCRC. He has worked with foundations (e.g., chair of the Research Grant review committee [study section] and Scientific Advisory Committee of the American Lung Association), industry (consultant, advisory board member, chair and member of data and safety monitoring committees) and the federal government on issues related to clinical and translational research.

Contacts