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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 form

How to fill out substantial amendment form?

1. Before starting, ensure you have the correct version of the substantial amendment form. You can usually obtain it from the relevant regulatory authority or organization.
2. Begin by filling out the basic information section of the form, which typically includes details such as the study title, protocol number, and sponsor information. Make sure to provide accurate and up-to-date information.
3. Proceed to the section that requires a description of the proposed amendment. Clearly explain the nature of the amendment, including any changes to the study design, endpoints, or investigational product.
4. If applicable, provide a rationale for the proposed amendment. This is important to help regulators understand the reasoning behind the changes and determine whether they are justified.
5. Review the section related to the impact on participant safety and welfare. Describe any potential risks or benefits associated with the amendment and the measures taken to mitigate these risks.
6. In the section addressing informed consent, outline how the proposed amendment will impact the consenting process, including any changes to the consent form or additional information that participants need to know.
7. If required, attach any supporting documents or materials that are relevant to the amendment. This may include revised study protocols, additional data, or updated investigator brochures.
8. Finally, ensure that all necessary signatures and dates are provided in the appropriate sections of the form. This typically includes the investigator, sponsor, and any other relevant parties involved in the study.

Who needs substantial amendment form?

1. Investigators or researchers involved in clinical trials or other regulated studies that require substantial changes to the original approved protocol may need to fill out a substantial amendment form.
2. Sponsors or organizations that are responsible for overseeing the conduct of the study and ensuring compliance with regulatory requirements will also typically need to submit a substantial amendment form.
3. Additionally, regulatory authorities or ethics committees that oversee the approval and oversight of the study may require the submission of a substantial amendment form to review and authorize any proposed changes.

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