FDA IND/IDE Triage Intake

Per CU Anschutz policy, all locally held INDs and IDEs must follow this single-point-of-entry process.



You must complete this form to request assistance for:


  • any investigator-initiated project requiring communication with FDA


  • projects that are industry-sponsored but the investigational product is manufactured on campus


  • a consult with one of our regulatory specialists


Triage to the appropriate intake entity will occur from this form and you can expect a response within 2 business days.


Please be sure to answer all questions that are visible in the form to ensure your request is processed appropriately.




You do not need to complete this form if:


  • your project is industry sponsored and the investigational product is manufactured off-site


  • your project does not require communication or interaction with the FDA



If your project does not require completion of this form, please proceed to the Human Subjects Research Portal to complete the standard Protocol Assessment Form: https://redcap.ucdenver.edu/surveys/?s=CF49MR9EEAAHRDHY

Provide name of the best person to contact for triage and project-related questions.

Provide email address of the best person to contact for triage and project-related questions.

Provide name of Project PI.

If the Principal Investigator is the same as the Project Contact, please enter 'SAME' in this field.

Provide project name/title.

Provide product name, and COMIRB # (if available).

Location of Majority of Study Visits*

Where are the majority of the study visits happening?

Support from the IND/IDE Program is currently offered only at CU Anschutz, UCH Metro and CHCO

The IND/IDE Office can still provide consultations to assist with questions for affiliate locations. Please hit Submit on this form to finalize your request. A Regulatory Specialist will contact you within 2 business days.

Emergency IND/IDE*

Are you requesting an emergency IND or IDE?

Emergency use INDs/IDEs are submitted directly to the FDA by physicians/study teams

You will need to work directly with the appropriate FDA branch and COMIRB ((303) 724-1055; comirb@uccdenver.edu)) on your submission. The IND/IDE Office does NOT submit emergency INDs/IDEs but can assist with reporting and tracking as needed once you have obtained initial FDA approval.


Please email ind.ide.office@cuanschutz.edu if you would like assistance with process, templates, etc.

Single Patient Compassionate Use*

Is this a single patient compassionate use request?

All single patient compassionate use submissions are supported by the IND/IDE Office

Please hit Submit on this form to finalize your request. A Regulatory Specialist will contact you within 2 business days.

FDA, Local*


1) Is the protocol locally written


2) AND will the product be used differently than it is currently approved for or investigated under a clinical trial?

Project not appropriate for triage

Your project does not meet the criteria to be handled via the IND/IDE Office, the Cancer Center or the Gates Institute. Please hit Submit on this form and proceed to the Human Subjects Research Portal to complete the standard Protocol Assessment Form: https://redcap.ucdenver.edu/surveys/?s=CF49MR9EEAAHRDHY.


If you need further assistance please reach out to the IND/IDE Office at ind.ide.office@cuanschutz.edu

Gates Institute*

Do you anticipate that this project will be supported by the Gates Institute?

This project will be triaged to the Gates Institute

Submitting this form will send your request directly to the Gates Institute. A Regulatory Specialist will contact you within 2 business days. Please continue filling out this form and hit Submit to finalize your intake request.

Manufacturing*

Who is manufacturing the product?

Oncology Indication*

Does this project involve treatment of an oncology condition?

This project will be triaged to the Cancer Center or the IND/IDE Office

Submitting this form will send your request directly to the Cancer Center or IND/IDE Office. A Regulatory Specialist will contact you within 2 business days. Please continue filling out this form and hit Submit to finalize your intake request.

Request Type*

What type of consultation are you requesting?

Were you referred to the IND/IDE Office?

Letting us know who referred you helps our office better prepare to assist you.

Are there time constraints or timeframes for this submission that we need to be aware of? (e.g., grant application, etc.)


Are there pertinent details to include here? For example:


  • Include any relevant details for your project that might be helpful at this intake stage


  • for straightforward consult questions, please include your question here and we will respond via email


  • For consult/meeting requests, please indicate this here along with the names of individuals you would like to be included in the meeting and we will work to schedule

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