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Substantial Amendment Notification Form (Cf. Section 3.7.b of the Detailed guidance on the request to the competent authorities for authorization of a clinical trial on a medicinal product for human

How to fill out substantial amendment notification form

How to fill out a substantial amendment notification form:

1. Obtain the substantial amendment notification form from the appropriate regulatory agency or organization.
2. Begin by providing your personal or organization's information, such as your name, contact details, and any identification numbers required.
3. Clearly state the title or description of the study or project for which the substantial amendment is being reported.
4. Provide a concise summary or description of the substantial amendment being made. This can include changes to the study protocol, participant population, interventions, outcomes, or any other relevant aspect.
5. Indicate the justification for the substantial amendment. This could be due to new scientific information, safety concerns, or unforeseen circumstances.
6. Include the date of when the substantial amendment was initiated or approved.
7. Include any supporting documents or evidence, such as revised study protocol, consent forms, or ethics committee approvals.
8. Sign and date the form, indicating your agreement to the information provided and the submission of the substantial amendment notification.
9. After completing the form, submit it to the appropriate regulatory agency or organization, following their specific submission requirements and procedures.

Who needs a substantial amendment notification form?

1. Researchers conducting clinical trials or other types of studies that require approval from regulatory bodies or ethics committees.
2. Pharmaceutical companies, contract research organizations, or other entities involved in drug development or medical research.
3. Institutions or organizations that oversee research and require notification of substantial amendments to their studies, such as universities or governmental agencies.

For pdfFiller’s FAQs

What is substantial amendment notification form?

The substantial amendment notification form is a document used to report significant changes or modifications to an existing application, agreement, or legal document.

Who is required to file substantial amendment notification form?

The individuals or organizations responsible for the existing application, agreement, or legal document are required to file the substantial amendment notification form.

How to fill out substantial amendment notification form?

To fill out the substantial amendment notification form, you need to provide the required information regarding the changes or modifications being made and any supporting documentation if necessary. The form usually includes fields for identifying the existing document, describing the amendments, and providing contact information for the filer.

What is the purpose of substantial amendment notification form?

The purpose of the substantial amendment notification form is to ensure proper documentation and notification of significant changes or modifications that may impact the rights, obligations, or interests of the parties involved.

What information must be reported on substantial amendment notification form?

The substantial amendment notification form typically requires information such as the identification of the existing document, a detailed description of the amendments, effective dates, and any supporting documentation. It may also request contact information for the filer.

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