Supporting novel advances in human health to become reality
- Mission
- About the Program
- Why a Central IND/IDE Office?
- What We Do
- Regulatory Sponsorship
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, Dr. Thomas Flaig.
The teamconsists of the IND/IDE Office (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.
View presentation: CU Anschutz IND/IDE Program April 2024
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 Office 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 Office, 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 Office 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).
Learn about CReST
Prep Budgets for Review
All project budgets will undergo an administrative review by IND/IDE Office staff to ensure sufficient funding is available to cover the costs associated with FDA regulated research with a local regulatory sponsor. Use your own or the budget template below.
Download Budget Template
FAQs
Yes, as of July 1, 2023, use of the IND/IDE Office or the Cancer Center for all submissions to FDA is mandatory for all locally written projects that require FDA oversight through an IND or IDE pathway, or any kind of communication with FDA.
Yes. The Oncology Clinical Research Support Team (OCRST) will coordinate with the IND/IDE Office and will specifically provide support for locally written oncology projects that require FDA oversight. More information on OCRST services available, the IIT Incubator, and IIT Review Committee can be found on the Cancer Center Intranet page. General inquiries can also be sent to CPDM.IIT@cuanschutz.edu.
The IND/IDE Office does not have the authority to determine whether FDA oversight is required for a project, but we can provide consultation on the best path forward.
Please contact us at IND.IDE.Office@cuanschutz.edu or ask your IND/IDE Office Regulatory Specialist for more information.
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.
sIND IDE holder responsibilities.docx
We do not submit emergency use compassionate use INDs/IDEs to FDA. Please work directly with FDA and COMIRBto submit these requests.
The IND/IDE Office staff will rely on you and your study team to draft and prepare all documents necessary for submission to FDA.
Our staff will review the documents, format them as needed for the specific submission, and upload them to the appropriate FDA submission platform. All communications with FDA will be managed and led by IND/IDE Office staff in close collaboration with the study team and the PI.
Study responsibilities will be tailored to your individual project based on the project type, regulatory sponsorship structure and your research team structure. Please contact us atIND.IDE.Office@cuanschutz.edu or ask your IND/IDE Office Regulatory Specialist for more information.
We do not support industry-initiated projects with industry IND or IDE sponsors.
While we don’t provide full-service submissions for the types of projects below, we can provide guidance and templates if needed:
- Single-patient emergency INDs/IDEs.
- Industry-initiated Expanded Access protocols.
- Single patient expanded access protocols with local IND holders that offer clinical trial participants the opportunity to continue on the investigational product beyond the clinical trial.
