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November 2018More details available in the Expanded Access Data Element DefinitionsClinicalTrials.gov is a service of the National Institutes of HealthExpanded Access Protocol Registration Template

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How to fill out expanded access protocol registration

01

Obtain the necessary forms for expanded access protocol registration from the sponsor or from the FDA website.

02

Fill out the forms completely and accurately, providing all required information about the patient, the investigational drug, and the treating physician.

03

Submit the completed forms to the appropriate review board or regulatory agency for approval.

04

Once approval is granted, follow any additional instructions for monitoring and reporting during the expanded access program.

Who needs expanded access protocol registration?

01

Patients who have exhausted all other treatment options and are not eligible for clinical trials may need expanded access protocol registration to access investigational drugs.

02

Physicians who seek to provide investigational drugs to their patients outside of a clinical trial may also need to complete the registration process.

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What is expanded access protocol registration?

Expanded access protocol registration is the process of submitting information to regulatory agencies for approval to provide investigational drugs to patients outside of a clinical trial.

Who is required to file expanded access protocol registration?

Sponsors or manufacturers of investigational drugs are required to file expanded access protocol registration.

How to fill out expanded access protocol registration?

Expanded access protocol registration is typically filled out online through the appropriate regulatory agency's website.

What is the purpose of expanded access protocol registration?

The purpose of expanded access protocol registration is to allow patients with serious or life-threatening conditions access to investigational drugs that are not yet approved by regulatory agencies.

What information must be reported on expanded access protocol registration?

Information such as the proposed use of the investigational drug, patient eligibility criteria, safety monitoring plans, and informed consent processes must be reported on expanded access protocol registration.

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