Get Substantial Amendment Form

Filling out the Substantial Amendment Form online is an important step in notifying the competent authorities and ethics committees about changes in a clinical trial. This guide will provide you with clear, step-by-step instructions to help you complete the form accurately and efficiently.

Follow the steps to complete the form online.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. In Section A, indicate the type of notification by selecting the appropriate option: authorization to the competent authority, opinion to the ethics committee, or information only. Ensure that you complete A.1 to A.4 based on your specific submission.
3. Proceed to Section B to identify the trial. Indicate if the substantial amendment concerns multiple trials and provide the EudraCT number and the full title of the trial in fields B.2 and B.3.
4. In Section C, fill out the identification of the sponsor responsible for the request, including the organization, contact person's name, address, and contact details in C.1.
5. If applicable, complete Section C.2 for the legal representative of the sponsor, providing the same type of information as in Section C.
6. Choose your role in Section D, clarifying whether you are the sponsor, legal representative, or an authorized person, and fill out the corresponding details.
7. In Section E, specify the substantial amendment identification including the sponsor's code number, version, and date. Explain the type of substantial amendment and the reasons for it in subsections E.2 and E.3.
8. Fill out Section G with a brief description of the changes being made to the trial.
9. If there are changes to the trial site or investigators, detail these in Section H, providing information on any new or removed sites and their respective principal investigators.
10. Specify any changes to instructions in Section I and append all relevant documents in Section J before submitting.
11. Finally, sign and date the applicant section in Section K to confirm that the information provided is accurate and complete.
12. Save your changes and download, print, or share the completed form as needed.

Ensure your submission is complete and accurate by filling out the Substantial Amendment Form online now.