Get the free Compassionate Use Worksheet - mmcri

Human Research Protection Program Institutional Review Board Treatment use of an IND/IDE Compassionate Use Worksheet Historically, compassionate use has been used to describe a situation in which

How to fill out compassionate use worksheet

Who needs compassionate use worksheet?

1. Physicians or healthcare professionals who want to request access to investigational drugs or treatments for their patients outside of a clinical trial.
2. Patients who have exhausted all available treatment options and wish to access experimental drugs or treatments that are still in the development stage.
3. Pharmaceutical companies or drug manufacturers who want to provide their investigational drugs to eligible patients under compassionate use.

How to fill out compassionate use worksheet:

1. Begin by gathering all the necessary information about the patient, such as their medical history, current condition, and any previous treatment options they have tried.
2. Clearly state the purpose of requesting compassionate use and explain why the patient is not able to participate in a clinical trial.
3. Provide detailed information about the investigational drug or treatment, including its name, dosage, mode of administration, and any associated risks or potential benefits.
4. Include any supporting documentation, such as medical records, test results, or expert opinions, to strengthen the case for compassionate use.
5. Ensure that all necessary consent forms from the patient or their legal representative are completed and included in the application.
6. If applying on behalf of a patient, the physician or healthcare professional should provide their credentials, contact information, and any relevant affiliations.
7. Double-check that all required sections of the compassionate use worksheet are properly filled out and that there are no missing or inaccurate details.
8. Review the completed worksheet and make any necessary revisions or additions to ensure clarity and coherence.
9. Submit the compassionate use worksheet to the appropriate regulatory authority or institution responsible for evaluating such requests, following their established guidelines and procedures.
10. Keep a copy of the completed worksheet for records and reference purposes, and document any interactions or communications related to the compassionate use request.

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What is compassionate use worksheet?

Compassionate use worksheet is a form that allows patients to access investigational drugs outside of a clinical trial.

Who is required to file compassionate use worksheet?

Patients or their healthcare providers are required to file compassionate use worksheet.

How to fill out compassionate use worksheet?

The compassionate use worksheet can be filled out by providing patient information, drug details, and justification for the use of the investigational drug.

What is the purpose of compassionate use worksheet?

The purpose of the compassionate use worksheet is to provide access to potentially life-saving treatments for patients who do not qualify for clinical trials.

What information must be reported on compassionate use worksheet?

Information such as patient's medical history, details of the investigational drug, and justification for its use must be reported on the compassionate use worksheet.