Clinical Research Support
The Center for Clinical Research
The Center for Clinical Research (CCR) is also here to help you address your study needs, large or small. CCR works closely with local Institutional Review Boards (IRB) at Northwestern University and Ann & Robert H. Lurie Children's Hospital as well as external IRB offices to reduce investigator burden, share best practices, maximize quality and efficiency of all programs and quickly resolve issues when they arise.
If you know which CCR services you would like to use, please complete the CCR Intake Form. If you are not sure where to start, request a Studio Consultation for an opportunity to learn how CCR services can help with your research project.
In addition to Northwestern University Clinical Research Unit space and services, CCR offers the following:
The Regulatory Unit of CCR assists investigators with meeting essential regulatory activities and provides training, mentoring and general support to their research staff. Services include:
- IRB submission of new protocols and amendments
- Preparation and negotiation of informed consent documents
- Completion of ancillary requirements, including sponsor FDA regulatory documents and assisting with regulatory matters during monitor visits
- Assembly of regulatory binders
- Support for Investigational New Drug/Investigational Device Exemption applications
The Regulatory Unit also closely collaborates with the IRB at Northwestern University and Ann & Robert H. Lurie Children's Hospital of Chicago. These partnerships have led to marked efficiencies and innovative approaches in regulatory compliance, including the development of processes for the use of external (third-party) IRBs, a first for NUCATS, and joint pediatric-adult IRB panel for studies in which participants are seen at both Northwestern and Lurie Children’s facilities.
Have a regulatory question? Attend Regulatory Drop-in Hours.
Other useful resources include:
- Support for ClinicalTrials.gov
For ClinicalTrials.gov registration and reporting requirements, contact ClinicalTrials.firstname.lastname@example.org.
- Good Clinical Practice and Research Staff Training
We offer live and online training programs to professionals learn about the federal regulations governing research and more.
- Northwestern IRB
Access helpful templates, policies and IRB training opportunities.
Recruitment & Retention Support
Without participants, research trials can be underpowered or, worse yet, terminated due to low enrollment. CCR offers the participant recruitment expertise crucial to meeting enrollment goals. Services include:
- Strategic marketing plan development
- Recruitment material creation (e.g., print advertisements)
- IRB submission of recruitment plans and materials
- Fielding calls from potential participants via toll-free number
- Pre-screening potential participants
You may also want to explore the following resources:
- Recruit Tool
- A web-based research registry and participant screening system.
- Northwestern Medicine Enterprise Data Warehouse
- Offers a number of methods to support research study recruitment.
- Center for Community Health
- Supports collaborations between academic and community-based.
- An online all-disease, volunteer recruitment registry.
Study Coordination Support (Nurse & Non-Nurse)
Investigators can hire our trained nurse and non-nurse certified coordinators for full or part-time use to handle the day-to-day details of clinical research trials. Our flexible scheduling means we can provide research support specific to the needs of the investigator. Our study coordinators can help with:
- Attending pre-site and investigator meetings
- Obtaining informed consent
- Conducting study visits
- Collecting and recording data
- Completing case report forms
- Obtaining and processing biological specimens
- Maintaining regulatory documents
- Participating in study monitor visits
Clinical Research Coordinators and research support staff (regulatory, recruitment and financial) meet monthly on the Chicago campus to hear informative, educational presentations on topics related to study coordination and conducting clinical research. Departments involved in research present at these meetings. Examples of topics discussed include: electronic informed consents, post-approval monitoring and FDA IND/IDE processes. Meetings are held at noon on the second Tuesday of each month in the sixth floor surgical conference room of the Arkes Pavilion (676 N. St. Clair). For more information and to join, email the Center for Clinical Research.
Budget & Finance Support
CCR negotiates study budgets for investigators and works closely with the Office of Sponsored Research to finalize contracts. CCR also assists with:
- Budgets preparation for clinical trials
- Reviews of financial sections of the clinical trial agreement
- Completion and submission of forms to the OSR with regular follow-up
- Invoices start-up costs
- Supervision of study-related invoicing and collections to ensure that sponsors have properly reimbursed investigators for research services (available upon request)
Not sure where to start with your budget? Take a look at a sample budget template.
CCR also offers assistance in navigating the resources and services available at Northwestern for clinical investigators and for proper and timely participation in ClinicalTrials.gov. There are fees for some of these services. To learn more about how we can help you, email email@example.com.
For more information about research at Northwestern University, contact the Office for Research.
Multi-Center Clinical Trials
The Trial Innovation Network (TIN) offers support to help investigators execute multi-center clinical trials and studies better, faster and more cost-efficiently; learn more.