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Clinical Research Administration Single Patient IND/IDE Portal

Returning?

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For help completing these questions, please contact the Clinical Research Support Center.

The information requested below is used to create a record for a Single Patient IND or IDE protocol. This is not an approval step. Once FDA and COMIRB approval have been obtained, the treating physician may request shipment of the investigational product and commence treatment.

Email address of person completing form:

* must provide value

Is this an Expanded Access use drug (IND) or device (IDE) application?

* must provide value

Is this an Expanded Access request for a single patient or multiple patients?

* must provide value

STOP!!!

Please close the survey and contact ClinicalResearchSupportCenter@ucdenver.edu for assistance.

COMIRB Protocol Number:

* must provide value

Protocol Title:

IND/IDE Format: "Single Patient IND/IDE for [DRUG/DEVICE], IND/IDE# [IND#/IDE#], Patient [PT INITIALS]"

* must provide value

Is this for treatment of a Cancer Center patient?

* must provide value

Yes

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Patient Initials

* must provide value

Age

* must provide value

Investigational Drug/Device Name

* must provide value

Name of the entity that will supply the drug/device (generally the manufacturer):

* must provide value

Is the IDE held by the manufacturer or a physician?

Manufacturer

Physician

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Have you discussed, with the patient, the cost of this device to the patient?

Yes

reset

Be advised that insurance may not cover the cost of the device. Please discuss this with your patient.

Disease ICD-10 Code

* must provide value

Enter Other Disease

* must provide value

Anticipated duration of treatment

Please provide in months, if possible.

* must provide value

Physician Name

* must provide value

Medical License Number (if known)

Department

* must provide value

Division/Section/Research Group

* must provide value

If Other, please provide department and division:

* must provide value

Oncology Management Group

* must provide value

Email address of treating physician

* must provide value

Secondary contact email (if any)

Sponsor Pharmacy Contact:

Please provide any important information the local pharmacist may need when reviewing this request.

* must provide value

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Which pharmacy will manage the product?

* must provide value

CHCO requires an Epic Use Plan and Protocol Request Form be submitted in order to build the study in Epic. Complete the following as soon as possible to avoid treatment delays:

Sign into https://casworkrequest.childrenscolorado.org/ with your CHCO credentials to complete the CAS Work Request.
Download and complete the CHCO Epic Research Protocol Request Form.
Submit the completed CHCO Epic Research Protocol Request Form along with your work request.

Enter the pharmacy name and address for product shipment:

* must provide value

Expand

Manufacturer Contact:

Where will the patient be treated?

* must provide value

Additional Comments

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Is there a Contract or Agreement that requires review (including those meant to be signed by the physician)?

Yes

reset

Manufacturer contact for contract/agreement questions (name/email)

* must provide value

Contract or Agreement

* must provide value

Upload file

Contract or Agreement, additional documents (optional)

Upload file

Contract or Agreement, additional documents (optional)

Upload file

Form FDA 3926 (signed)

* must provide value

Upload file

Request Letter to FDA or Manufacturer (must include treatment plan, monitoring plan, patient information/diagnosis, and why an S-IDE is justified. Contact clinicalresearchsupportcenter@ucdenver.edu for a template)

* must provide value

Upload file

FDA Approval Letter

Upload file

Treatment Consent Form (unsigned)

* must provide value

Upload file

Physician's CV

Upload file

Independent Physician Concurrence Letter

* must provide value

Upload file

Investigator's Brochure/Device Information (or sufficient product safety/efficacy information if no IB exists)

* must provide value

Upload file

Do you have a Letter of Authorization (LOA) or a Letter of Cross Reference (LOCR) from the manufacturer?

Yes

No (e.g. approved overseas only or approved for veterinary use)

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Please upload the manufacturer's Letter of Authorization (LOA or LoCR)

Upload file

Confirmation of cost of drug to patient if not included in LOA (an email is acceptable)

Upload file

OPTIONAL: Treating Physician's Medical License (can be looked up on DoRA)

Upload file

COMIRB Chair Concurrence or approval letter, if available

Upload file

Pharmacy Manual (optional)

Upload file

Treatment or Surgery Plan (optional)

Upload file

Clinical Trial Protocol (optional)

Upload file

Additional documentation (optional)

Upload file

Additional documentation (optional)

Upload file

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