The following request is intended to be used by URMC physicians interested in utilizing the Expanded Access pathway to obtain investigational drugs for individual patients. Information collected in this request will facilitate the Expanded Access process and should be completed as accurately as possible.
To facilitate completion of this request, we recommend the following information be readily accessible:
- Treating Physician's Contact Information
- Treating Physician's Qualifications (or Curriculum Vitae) plus medical license number
- Patient's Initials
- Clinical History of the Patient
- Investigational Drug Name
- Drug Manufacturer and Contact Information
- Treatment Plan
The above information will be entered into the FDA Form 3926.
The request will take approximately 10-20 minutes to complete. To initiate a request, please click 'Submit' once it is completed.
Expanded access, sometimes called "compassionate use", is the use of an investigational medical product (i.e., one that has not been approved by FDA) outside of a clinical trial. In order for the FDA to permit expanded access to an investigational drug outside of a clinical investigation, applicable criteria in 21 CFR 312.305(a) must be met. Please ensure the following criteria apply prior to submitting your request for an individual patient IND.
(1) The patient to be treated has a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition;
(2) The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated; and
(3) Providing the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.
If all of these criteria are met, please continue this submission by clicking 'Submit'.
Treating Physician's First Name
* must provide value
First Name
Treating Physician's Last Name
* must provide value
Last Name
Physician's Email
* must provide value
Business or personal email is acceptable.
Confirm Physician's Email
* must provide value
Same email as entered previously.
Physician's Phone
* must provide value
(555) 555-5555
Department
* must provide value
URMC Department
If an additional contact (coordinator, resident, NP, pharmacist, etc.) should be included on correspondence related to this request, please provide their last name.
Last Name
Additional contact's first name.
First Name
Please provide the preferred email address for the additional contact person.
Additional Contact's Email
Will this expanded access IND be used to treat a single patient or multiple patients?
* must provide value
Single Patient
Multiple Patients
If a single patient, include the patient initials here.
* must provide value
Initials only (2 or 3 letters)
If more than single patient use is intended, indicate the approximate number of patients who will come under this IND.
* must provide value
When does the patient need to receive treatment?
* must provide value
Within the next 24 hours
24-48 hours
48-72 hours
In the coming week or beyond
Additional comments about timeline for patient treatment.
Did you respond "Yes" to both of the questions above? If yes, this survey will close and you should call the FDA for emergency approval. See FDA contact info here .
* must provide value
Yes
No
Select one.
Type of Request Please refer to RSRB Policy 607 Emergency Use of Investigational Products
* must provide value
Emergency Use - Patient has an immediate life-threatening condition that requires treatment within the next 24 hours. A verbal emergency IND should be requested from the FDA when a patient will need to be treated before a written submission can be sent to the FDA to authorize drug use. ______________________________________________________
Non-Emergency Use - Patient has a serious or life-threatening condition that requires treatment outside of the criteria defined by emergency use. Unless FDA notifies the physician that treatment may begin earlier, there may be up to a 30-day waiting period before treatment with the drug may begin for these types of requests.
Select one.
For a treatment which does not meet the definition of "Emergency Use", but where the patient would benefit from an accelerated process, please provide those details below.
Have you already contacted FDA regarding this request?
* must provide value
Yes
No
Select one.
Tell us about your FDA interaction thus far.
* must provide value
If a company holds the expanded access IND, provide the company name.
* must provide value
If company held, what is the IND number?
* must provide value
Download the FDA form 3926 (or the 1571 in certain cases) from the
FDA Forms website . IMPORTANT NOTE: You will need to right click and "Save As" so that the secure document is downloaded locally and does not open in a browser. It will not open properly from within a browser.
For an initial submission, complete sections 1, 2, 3a, 4, 5 and 6 with information you have compiled including:
- Patient's Initials
- Clinical History of the Patient
- Investigational Drug Name
- Drug Manufacturer and Contact Information
- Treatment Plan
Complete fields 7 and 8 with YOUR information including a CV or a summary as noted.
For an initial submission, leave field 9 blank, and check the box for 10a as you will use the RSRB for IRB oversight.
Once all the required fields are done, you should be able to sign and date in field 11.
Upload a draft of the completed FDA Form 3926. This should be mostly completed, but we will assist you with any fields where questions remain.
NOTE: If planning a Treatment IND or Intermediate Size Patient Population that falls under Expanded Access, but it is not a single patient use, please upload the completed FDA Form 1571 instead of the Form 3926.
Indication
* must provide value
Diagnosis or Reason for Treatment
Investigational Drug Name
* must provide value
Treatment name.
Upload the package insert or Investigator Drug Brochure
Manufacturer
* must provide value
Supplier name.
Drug Manufacturer Contact Information
Name, Phone, Email (if known)
* must provide value
Have you already contacted the manufacturer about this request?
* must provide value
Yes
No
Tell us about your manufacturer interaction thus far.
* must provide value
Do you have a Letter of Authorization from the manufacturer to use this investigational product?
* must provide value
Yes
No
If yes, please upload the Letter of Authorization.
Have you been given a contract, agreement, CDA or other document to sign?
* must provide value
Yes
No
Please upload the contract, agreement, CDA or other document you have been asked to sign.
It is fine if this is still in draft form and has not been fully red-lined or signed yet.
* must provide value
Do you have another document to upload (case report form, investigator brochure, FDA Form 1572, consent form, etc)?
* must provide value
Yes
No
Please upload the additional document.
Do you have another document to upload?
* must provide value
Yes
No
Please upload additional document.
* must provide value
Which investigational pharmacy at URMC will handle drug preparation?
Contacts:
Investigational Drug Service (IDS)
275-6153
Cancer Center Investigational Drug Service (CC-IDS)
275-4280
Investigational Drug Service (IDS)
Cancer Center Investigational Drug Service (CC-IDS)
Other
If other entity will dispense product, please specify.
* must provide value
If this Expanded Access request is coming from Wilmot Cancer Center, indicate the PRMC number here.
Do you have a "Clinical Study Protocol"?
* must provide value
Yes
No
Upload the Clinical Study Protocol. The Clinical Study Protocol for Expanded Access Use can utilize a streamlined protocol and informed consent document. Refer to RSRB Protocols page for Treatment Use Protocol templates.
Please upload the protocol even if it is in draft form.
* must provide value
Please select one.
* must provide value
The uploaded Clinical Study Protocol is a draft.
The Clinical Study Protocol is IRB-approved.
For questions on the expanded access process, please contact the Office of Regulatory Support.
Reg_Support@urmc.rochester.edu
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