Get Deviation Report Example

This guide provides clear instructions on how to effectively complete the Deviation Report Example form online. Users will find step-by-step guidance tailored for a wide audience, ensuring a smooth and informed filing process.

Follow the steps to successfully complete the Deviation Report Example

1. Press the ‘Get Form’ button to access the form and open it in the designated editor.
2. In the CIRB Reference No section, enter the unique reference number associated with your study.
3. For the Protocol Title field, input the full title of the research protocol that is being reported.
4. In the Principal Investigator field, provide the name of the principal investigator overseeing the study.
5. Fill in the Designation/Department/Institution section with the appropriate title and institutional affiliation of the principal investigator.
6. In the Description of Event section, detail the nature of the incident, including the date it occurred. If applicable, include the subject identifier.
7. Explain why the event occurred in the subsequent text field and describe its outcome.
8. Indicate whether the event affected the safety, rights, or well-being of the research participant or others involved.
9. If corrective actions were taken, describe those in the following text field.
10. Outline any preventive actions that will be implemented to prevent future occurrences of the incident.
11. Provide additional comments if necessary in the designated space.
12. Answer whether the event has been reported to the Study Sponsor/Grant Agency, and if so, describe any responses received.
13. If the event was not reported to the Study Sponsor/Grant Agency, provide rationale for the decision.
14. Complete the Declaration of Principal Investigator section by signing and dating the report. Include your full name, institution, and department.
15. Review all entered information for accuracy before proceeding to save changes, download, print, or share the form.

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