Get Deviation Report Form

Filling out the Deviation Report Form is essential for documenting significant deviations in research protocols. This guide will provide you with clear, step-by-step instructions to ensure accurate and timely completion of the form online.

Follow the steps to complete the Deviation Report Form online

1. Press the ‘Get Form’ button to access the form and open it in the editor.
2. Begin by entering the sponsor's name in the designated field. Make sure to provide accurate details as this identifies the entity responsible for the research protocol.
3. Fill in the protocol number assigned to the study. This is important for tracking the specific research activity your deviation relates to.
4. Enter the principal investigator’s name clearly in the appropriate section. This identifies the individual overseeing the study.
5. Complete the Compass IRB # field. This number is crucial for reference by the Institutional Review Board.
6. In the Protocol Deviation Information section, list the significant deviations. Remember that these must be reported no later than ten working days from when you became aware of the event.
7. Input the subject initials if applicable to maintain anonymity while providing necessary identification.
8. Record the date of occurrence of the deviation. This helps in tracking timelines.
9. Provide the date when the site was notified of the event or when staff became aware of it.
10. Indicate whether the sponsor has been notified by checking 'Yes' or 'No' in the corresponding field.
11. Respond to whether you received sponsor approval prior to the deviation and if this is being reported within ten days of discovery. If not, include a brief explanation in the space provided.
12. If the deviation has occurred at your site previously during this study, please explain in the space provided.
13. Detail the nature of the deviation in the ‘Describe the Deviation’ section, ensuring you provide a comprehensive overview.
14. Explain the reason for the deviation clearly, aiding in understanding the circumstances surrounding it.
15. Outline the corrective actions that have been taken to address the deviation and prevent recurrence.
16. Describe the preventive actions that are being implemented to ensure the same deviation does not occur in the future.
17. Certify the accuracy of the information by providing the name, title, and signature of the principal investigator or sub-investigator, along with the date.
18. Finally, review the provided information for completeness before saving changes, downloading, printing, or sharing the form as necessary.

Complete your Deviation Report Form online today for efficient documentation and compliance.