Get Protocol Violation Reporting Form

This guide provides clear, step-by-step instructions for users on how to complete the Protocol Violation Reporting Form online. By following these steps, you can ensure accurate and timely reporting of protocol violations while maintaining participant safety and study integrity.

Follow the steps to effectively complete the form online.

1. Press the ‘Get Form’ button to access the Protocol Violation Reporting Form and open it in your preferred online editor.
2. Begin with the report details section by entering the trial title, EudraCT number, REC number, principal investigator’s name, site name and number, the country where the violation was recorded, and the participant number.
3. In the assessment section, confirm whether the violation may have impacted participant safety or study outcomes by selecting 'Yes' or 'No' for each aspect. Provide relevant details and include signatures and dates as required.
4. Next, describe the details of the violation. Enter the date it occurred, specify if it constitutes an urgent safety measure, and provide a succinct description of the violation. Indicate the relevant violation code and confirm whether the principal investigator has been informed.
5. Move on to actions taken. Document the site actions taken to correct or document the violation, as well as corrective and preventative actions to avoid future violations. Include a justification for the actions taken.
6. Complete the information source section by entering the name, address, and telephone number of the principal investigator or their designee. Ensure they sign and date this section.
7. Review the completed form carefully. Once satisfied, save changes, and choose to download, print, or share the form as needed.

Take the next step in ensuring study integrity by completing your Protocol Violation Reporting Form online.