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This policy defines 'Compassionate Use' and Expanded Access Protocols in research, detailing the requirements for human subject use and the roles of various stakeholders.

How to fill out expanded access and use

How to Fill Out Expanded Access and Use:

1. Start by obtaining the necessary form for expanded access and use. This form is typically provided by the relevant regulatory agency or institution overseeing the use of investigational drugs or devices.
2. Read through the form thoroughly to understand the requirements and instructions. It is important to ensure that you meet the eligibility criteria for expanded access and use before proceeding.
3. Provide your personal information accurately in the designated sections of the form. This may include your full name, contact details, date of birth, and any other relevant identification information.
4. Next, provide details about the investigational drug or device being requested for expanded access and use. This may include the name of the drug or device, its purpose, potential benefits, and any known risks or side effects.
5. Explain the reason why you are seeking expanded access and use of the investigational product. This may involve describing the severity of your medical condition, previous treatment options that have been exhausted, and why you believe this particular drug or device may be beneficial for you.
6. Consult with your healthcare provider or physician to ensure that they are aware of your intention to seek expanded access and use. They may need to provide additional information or documentation to support your request.
7. Include any relevant medical records, test results, or supporting documents that may strengthen your case for expanded access and use. This can help the regulatory agency or institution reviewing your request to better understand your medical history and current condition.
8. Review the completed form thoroughly to ensure that all the required sections have been filled out accurately and completely. Consider seeking assistance from a healthcare professional or legal advisor if you have any doubts or uncertainties.

Who Needs Expanded Access and Use:

1. Patients who have exhausted all available treatment options: Expanded access and use is typically considered as a last resort for patients who have tried approved treatments for their medical condition but have not experienced the desired improvement or relief.
2. Individuals facing life-threatening or serious conditions: Expanded access and use is often granted to patients who are suffering from severe or life-threatening illnesses where no other viable options exist. This allows them to access investigational drugs or devices that may provide potential benefits.
3. Patients who do not qualify for clinical trials: Some patients may be ineligible to participate in ongoing clinical trials due to certain exclusion criteria. In such cases, expanded access and use may be an alternative option to consider.
4. Children or vulnerable populations: In certain cases, expanded access and use may be granted to children or other vulnerable populations who are unable to fully consent or participate in clinical trials.
5. Physicians and healthcare providers: In some instances, expanded access and use may be sought by healthcare professionals on behalf of their patients, particularly if they believe that the investigational product could significantly improve the patient's condition or prognosis.

It is important to note that the availability of expanded access and use may vary depending on the country, regulatory agency, and specific circumstances. It is recommended to consult with healthcare providers or regulatory authorities for detailed guidance and information specific to your situation.

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What is expanded access and use?

Expanded access, also known as compassionate use, is a pathway that allows patients with serious or life-threatening conditions to gain access to investigational drugs, biologics, or medical devices that have not yet been approved by regulatory authorities. It is a means to provide treatment options when there are no satisfactory alternatives available.

Who is required to file expanded access and use?

The responsibility of filing expanded access requests typically lies with the treating physician, who must submit the necessary documentation and obtain approval from both the sponsor of the investigational product and the regulatory authorities.

How to fill out expanded access and use?

To fill out expanded access requests, the treating physician must provide detailed information about the patient's medical condition, treatment options, the rationale for seeking expanded access, and ensure that the patient meets the eligibility criteria established by the sponsor and the regulatory authorities.

What is the purpose of expanded access and use?

The purpose of expanded access is to provide a way for patients with serious illnesses to access potentially life-saving treatments before they are officially approved and available on the market. It aims to address unmet medical needs and provide potentially beneficial options for patients.

What information must be reported on expanded access and use?

When filing expanded access requests, physicians must report information such as the patient's medical history, previous treatments, relevant laboratory results, any known contraindications or potential risks, and the planned dosage and duration of the requested treatment.