Get Request For Authorisation Of A Substantial Amendment To A Clinical Trial - Ctsu Ox Ac

This guide provides clear and supportive instructions on how to accurately fill out the Request for Authorisation of a Substantial Amendment to a Clinical Trial form, ensuring compliance with regulatory requirements. Whether you are new to this process or require a refresher, this guide is designed to help you navigate each section with ease.

Follow the steps to successfully complete the form online.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Identify the purpose of your request by checking the appropriate box for either authorisation from the Competent Authority, opinion from the Ethics Committee, or notification for information only.
3. Complete section A1 by providing the EudraCT number, the full title of the trial, sponsor’s protocol code number, version, and date.
4. In section A2, fill out the amendment identification by including the sponsor's protocol amendment code number.
5. For section B, provide identification details of the sponsor, including the organization's name, the contact person's name, address, telephone number, fax number, and email.
6. In section C, identify the nature of your application, specifying whether you are requesting on behalf of the sponsor, legal representative, or another authorized person.
7. Fill out the type of amendment section D by ticking the appropriate boxes regarding the content of the amendment.
8. In section E, briefly describe the reason for the amendment, ensuring clarity and precision.
9. Detail the changes made in section F, referencing any previously submitted materials for clarity.
10. In section G, list the documents that you will submit alongside the amendment form, ensuring all necessary documentation is included.
11. Finally, sign the applicant section I to confirm the information is accurate and that the trial will adhere to the protocol and regulations. Ensure to include the date and print name as required.
12. Once all sections are completed, users can save changes, download the form, print it, or share it as necessary.

Begin your submission process online by completing the necessary forms today.