Get the free Expanded Access Individual Patient - University of Pittsburgh - o3is pitt

Guidelines for the Submission of an Expanded Access IND to Permit Diagnosis, Monitoring or Treatment of an Individual Patient with an Investigational Drug or a REMS-restricted, Approved Drug Guidelines:

How to fill out expanded access individual patient

How to fill out expanded access individual patient:

1. Begin by obtaining the necessary forms from the relevant regulatory authority or medical institution. These forms may include an application for expanded access and consent forms.
2. Carefully read through all instructions provided with the forms to ensure you understand the requirements and process.
3. Complete the patient information section of the expanded access form. This typically includes personal details such as name, date of birth, contact information, and medical history.
4. If required, provide information about the treating physician or healthcare professional overseeing the patient's care. This may involve their name, contact details, and any relevant licenses or certifications.
5. Describe the medical condition or disease for which the patient requires access to the investigational treatment. Include details such as diagnosis, treatment history, and any documented attempts at alternative treatments.
6. Clearly state the reasons for seeking expanded access for the individual patient. This may involve explaining the patient's lack of suitable treatment options, the potential benefits of the investigational treatment, and any supporting medical literature or evidence.
7. Consent forms are essential for expanded access individual patients. Ensure that both the patient and, if applicable, their legal representative or guardian, have reviewed and signed all necessary consent documents.
8. Compile any supporting documents requested by the regulatory authority or medical institution, such as medical records, diagnostic test results, or letters of recommendation from healthcare professionals.
9. Submit the completed expanded access application, consent forms, and any supporting documents as instructed by the regulatory authority or medical institution. Double-check that all required sections have been completed accurately, and keep copies of the documents for your records.

Who needs expanded access individual patient:

1. Patients who have exhausted all standard treatment options for their medical condition or disease.
2. Patients who are unable to participate in clinical trials due to specific eligibility criteria or logistical constraints.
3. Patients who have a serious or life-threatening condition for which there is no approved treatment or alternative therapies have been unsuccessful.
4. Patients whose treating physician believes that the investigational treatment offers potential benefits that outweigh the potential risks.
5. Patients who have obtained the necessary approvals and authorization from regulatory authorities and medical institutions to access the investigational treatment outside of clinical trials.

Note: It is important to consult with healthcare professionals, regulatory authorities, and relevant medical institutions to ensure compliance with local regulations and guidelines regarding expanded access programs.

For pdfFiller’s FAQs

What is expanded access individual patient?

Expanded access individual patient refers to a compassionate use program that allows a single patient to access an experimental treatment outside of a clinical trial.

Who is required to file expanded access individual patient?

The treating physician is typically required to file for expanded access individual patient on behalf of the patient.

How to fill out expanded access individual patient?

The treating physician needs to complete the necessary paperwork and submit it to the pharmaceutical company or regulatory authority overseeing the treatment.

What is the purpose of expanded access individual patient?

The purpose of expanded access individual patient is to provide access to experimental treatments for patients who have exhausted all other options.

What information must be reported on expanded access individual patient?

Information such as the patient's medical history, rationale for seeking the treatment, and potential risks and benefits of the experimental treatment must be reported.

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