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Clinical Research Infrastructure

The Center for Clinical Research (CCR) offers the infrastructure necessary 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 of Chicago 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 virtual Studio Consultation for an opportunity to learn how CCR services can help with your research project or browse the links below. To learn more about how we can help you, email ccr@northwestern.edu.

  • Multicenter Clinical Trials
    The Trial Innovation Network offers support to help investigators execute multi-center clinical trials and studies better, faster and more cost-efficiently.
  • Clinical Research Coordinator Resources
    We offer a number of resources for clinical research staff, intended to support and complement departmental efforts to standardize onboarding and training initiatives.
  • Clinical Research Units
    We offer research-specific nursing and laboratory services for the implementation of clinical research at Northwestern Memorial Hospital and Ann & Robert H. Lurie Children's Hospital of Chicago.
  • CCR Regulatory Unit
    This unit assists investigators with meeting essential regulatory activities and provides training, mentoring and general support to their research staff.
  • CCR Finance Unit
    The Finance Unit assists investigators and study teams with finance-related activities by negotiating budgets and helping to finalize contracts.

Recruitment & Support

Participant recruitment timeframes are one of the most important parts of the clinical trial process to consider. CCR offers participant recruitment resources to assist with research study advertisement that you can find by visiting our Research Resources page and sort the Toolkit Directory by "Recruitment." If you’d like to learn more about what participating in a clinical trial involves or to sign up to participate, visit the Feinberg Research site.

ClinicalTrials.Gov

ClinicalTrials.gov is a web-based resource that provides patients, their family members, healthcare professionals, investigators and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The site is maintained by the National Library of Medicine at the National Institutes of Health. Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the site (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. This site and database of clinical studies is commonly referred to as a "registry and results database."

FAQ

 How do I change my anticipated (or actual) Primary Completion Date in the Protocol Registration and Results System on ClinicalTrials.gov?

Northwestern's Clinical Research Center has created a how-to document to help investigators navigate this process. The Primary Completion Date should be updated to an actual date 30 calendar days after the clinical trial reaches its actual primary completion date.

 Is there a charge for listing studies on ClinicalTrials.gov?

No, there is no charge for listing studies on ClinicalTrials.gov. ClinicalTrials.gov is a free service of the National Institutes of Health, provided through the National Library of Medicine.

 My study is not yet approved by a human subjects review board (ethics review committee, institutional review board). Can I enter it on ClinicalTrials.gov?

Most studies require approval from a human subjects review board. If your study requires approval, you may register your study on ClinicalTrials.gov prior to getting approval. Because review board approval is pending, your study will not be recruiting and the Overall Recruitment Status of the study should be set to “Not yet recruiting” (see Overall Recruitment Status data element on ClinicalTrials.gov) when registering it.

 Why can't I find my study on ClinicalTrials.gov?

The record has not yet been published to the public site by the ClinicalTrials.gov review team.

Once a study is registered or modified in the PRS, it is marked Entry Complete by the user. The Responsible Party (see Responsible Party data element on ClinicalTrials.gov) Approves and Releases the record to the ClinicalTrials.gov team for review. The ClinicalTrials.gov team reviews the record to identify possible errors, deficiencies, or inconsistencies that are not detected automatically during data entry. The Responsible Party will be notified of any issues that need correction and the record reset to In Progress, if changes to the record are needed. The review of information may take up to 30 days. Once all corrections or edits are made (Entry Completed), the Responsible Party will Approve and Release the record for review again. Once the ClinicalTrials.gov team has approved the corrections/edits, the record will be changed to Public and published to the ClinicalTrials.gov website.

 When will the NCT Number for my study be assigned?

The NCT Number, also called the ClinicalTrials.gov Identifier, is assigned after the protocol information has been Released (submitted) by the Responsible Party and passed review by ClinicalTrials.gov staff. At that time an email notification containing the NCT Number is sent. The record, including its NCT Number, will typically be available on ClinicalTrials.gov within two to five business days after it is released.

See How to Register Your Study for more information.

Participating Institutions: