Get Form 7: Protocol Deviation Form - The Ukstar Trial - University Of ...

Filling out the Form 7: Protocol Deviation Form for the UKSTAR Trial is a crucial step in documenting any deviations from the protocol or related procedures. This guide provides clear and supportive instructions to ensure you complete the form accurately and efficiently online.

Follow the steps to fill out the form correctly online.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Fill in the date of the event in the 'Date of Event' field using the format DD/MM/YYYY.
3. Enter the date of reporting in the 'Date of Reporting' field, also in DD/MM/YYYY format.
4. Provide a detailed description of the incident in the 'Description of incident' section. Be as informative as possible, ensuring that all relevant details are included.
5. Indicate whether the incident is classified as a protocol deviation, breach of Good Clinical Practice, deviation from other trial procedures, or breach of national legislation by checking the appropriate boxes.
6. Confirm if all related documents are attached by selecting 'Yes' or 'No' in the designated section.
7. Document the actions taken in response to the incident in the 'Action Taken' section.
8. Complete the section marked 'Person completing this form,' including your name, signature, and the date of completion.
9. For Oxford Trauma use only: If applicable, fill in the incident number, the name of the person taking action, their role, date, and signature.
10. Once all fields are completed, you can save changes, download, print, or share the form for submission.

Complete your forms online today for a seamless experience.