Clinical Research Regulatory Affairs
Supporting Novel Advances in Human Health to Become Reality
To facilitate advancement of CU Anschutz researchers’ innovations through expert support and collaboration to manage administrative, regulatory and safety elements of the product development lifecycle.
The IND/IDE Program at CU Anschutz was established in 2023 under the directive of the Vice Chancellor for Research, Thomas Flaig, MD.
The team consists of the IND/IDE Program (Vice Chancellor for Research) and the Cancer Center (School of Medicine). Research projects will be triaged to either entity based on project type and therapeutic area.
The program provides expertise and assistance to researchers involved in the development and clinical assessments of novel health solutions for investigator-initiated studies. We do this by partnering with research teams to centrally manage the responsibilities that are unique to the role of being a regulatory sponsor for FDA-regulated research.
So you can concentrate on your scientific work!
The collaboration between a central group of regulatory specialists and dispersed research teams with expertise in distinct disease areas allows for standardized and streamlined communication with FDA, thereby accelerating the process to obtain permission to proceed with research under FDA oversight.
The transfer of many of the administrative and regulatory sponsor-specific tasks from the research team to IND/IDE Program staff allows research teams to focus on the scientific aspects of their research and the clinical care of study participants.
IND/IDE Program team will:
- Help define the project’s regulatory strategy.
- Manage all communication with FDA throughout the project’s regulatory lifecycle.
- Provide guidance and support for all regulatory questions related to projects.
- Establish and train research teams on electronic regulatory folders to standardize the filing of documentation required for FDA-regulated research with a local regulatory sponsor.
- Train research teams on responsibilities associated with projects under local regulatory sponsorship.
- File all FDA communications in accordance with FDA requirements.
For investigator-initiated studies where the investigational product is manufactured by an entity affiliated with the University, CU Anschutz, rather than the study PI, may hold the IND/IDE and serve as the regulatory sponsor of the project. These projects will require institutional review from a leadership committee separate from the IND/IDE Program, and our office staff will help you navigate the process for submission to that committee.
A formal committee decision is required, and the committee’s decision letter will provide further details. The IND/IDE Program staff will begin work on your FDA submission once a committee decision letter is issued. Principal Investigators will hold the IND/IDE for investigator-initiated studies when the manufacturing process is owned and controlled by an external entity. No separate institutional approval is required to begin preparing your submission materials.
Intake | Study Guidance | Budgeting
Initiate Communication with the FDA
All locally held INDs and IDEs must use a single point of entry to initiate communication with the US Food and Drug Administration (FDA). Complete our intake form to triage your project to the IND/IDE Office or the Cancer Center, or to request a regulatory consultation.
Get Support from Real People
Our office works closely with the Clinical Research Support Team (CReST) who has a range of fee-for-service solutions. CReST provides services directly relevant to the studies under FDA oversight at CU (monitoring, DSMB services, electronic data capture builds, and coordinator support).
Three Avenues for Investigators Based on Type of IND Sponsorship
Investigator-led Studies
How is this defined? Principal Investigators will hold the IND/IDE for investigator-initiated studies when the manufacturing process is owned and controlled by an external entity.
What should investigators know and do for this type of sponsorship? No separate institutional approval is required to begin preparing your submission materials. Fill out an IND/IDE Office intake/triage form to start the process.
University-led Studies
How is this defined? For investigator-initiated studies in which the investigational product is manufactured by an entity affiliated with the University, CU Anschutz, rather than the study PI, may hold the IND/IDE and serve as the regulatory sponsor of the project. These projects will require institutional review from a leadership committee separate from the IND/IDE Office.
What should investigators know and do for this type of sponsorship? Office staff will help you navigate the process for submission to that committee. A formal committee decision designating CU Anschutz as the regulatory sponsor is required. The IND/IDE Office staff will begin work on your FDA submission after a committee approval letter is issued.
Compassionate Use Studies
How is this defined? Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Per the FDA, expanded access may be appropriate when all the following apply:
- Patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
- Investigational drugs, biologics, or medical devices have not yet been approved or cleared by the FDA, and the FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may or may not be effective in treating the condition, and its use may cause unexpected, serious side effects.
What should investigators know and do for this type of sponsorship? We assist with single-patient compassionate use INDs/IDEs. Please submit a request using the triage intake form above.
Please review the document below and be aware of the responsibilities of submitting a single-patient compassionate use request:
Responsibilities as IND/IDE holder for single-patient compassionate use
We do not submit emergency use or compassionate use INDs/IDEs to the FDA. Please work directly with the FDA and COMIRB to submit these requests.
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Contact
Program Director:
Tiffany Cull
Regulatory Specialists:
- Allison Deere
- Allie Lynn
- Jennifer Su
- Monica Manik
- Robert Breidenstein
- Anisha Marni
Medical Directors:
- Cecilia C. Low Wang, MD
- Jennifer Armstrong, MD
Email:
INTAKE FORM