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Federal Agency for Medicines and Health Products Euro station II Place Victor Horseplay 40/40 1060 BRUSSELS www.fagg.be www.afmps.beAddendum to the Guidance on the Management of Clinical Trials during

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How to fill out addendum to form guidance

1. To fill out an addendum to form guidance, follow these steps:
2. Start by reading the form guidance that accompanies the form you are working with. This will help you understand the purpose of the addendum and how to properly complete it.
3. Identify the sections or questions in the form that require additional information or clarification. These are the areas where you will need to provide an addendum.
4. Create a document or separate sheet of paper where you can write the addendum. Make sure to include a clear title or header that indicates it is an addendum to the original form.
5. Write a brief explanation or description of each section or question that requires an addendum. Be concise and to the point, providing only the necessary information.
6. Number each addendum point or section to correspond with the form sections or questions you are addressing. This will make it easier for the reader to follow.
7. Ensure that your addendum is clear, organized, and easy to understand. Use appropriate formatting, such as bullet points or headings, to make it visually appealing and facilitate comprehension.
8. Review your completed addendum to ensure accuracy and completeness. Make any necessary corrections or additions before submitting it along with the original form.
9. Attach the addendum to the original form, either by stapling or paper clipping them together. If submitting electronically, ensure that the addendum is properly named and clearly indicates its purpose.
10. If required, make copies of the completed form and addendum for your own records or for any additional parties that may need a copy.
11. Submit the completed form and addendum as instructed, whether via mail, in person, or electronically. Follow any specific submission guidelines or requirements provided.
12. By following these steps, you will be able to successfully fill out the addendum to form guidance.

Who needs addendum to form guidance?

1. Addendum to form guidance may be needed by individuals or organizations who:
2. - Are completing a form that requires additional information not covered in the original form guidance.
3. - Need to clarify or provide more details for specific sections or questions in the form.
4. - Have encountered changes or updates to the original form after its release.
5. - Have specific requirements or situations that require supplementary information beyond what is provided in the form guidance.
6. - Want to ensure that their responses are accurately understood and interpreted by the recipient of the form.
7. - Are instructed or recommended to include an addendum by the issuing authority or relevant parties involved.
8. Whether you need an addendum to form guidance or not depends on the specific circumstances and requirements of the form you are working with.

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