Protocol Deviation Protocol Number/Title: PI Name: Site: Subject ID: Date of deviation: Date deviation identified: Deviation description: Deviation identified by: If other, specify: Type of deviation identified: If other, specify: Did the protocol deviation result in an AE? Yes No Comments/Clarification: Did the subject continue in the study? Yes No Explain: Does the deviation meet IRB reporting requirements? Yes No Comments/Clarification: Date the deviation was reported to the IRB (if applicable): Action taken to resolve this deviation (if any): Deviation impact (check all that apply): Study Validity Safety No Impact Outcome Measures Other, specify: Investigator Signature: Date: ______________ (dd/mmm/yyyy)
Protocol Deviation Protocol Number/Title: PI Name: Site: Subject ID: Date of deviation: Date deviation identified: Deviation description: Deviation identified by: If other, specify: Type of deviation identified: If other, specify: Did the protocol deviation result in an AE? Yes No Comments/Clarification: Did the subject continue in the study? Yes No Explain: Does the deviation meet IRB reporting requirements? Yes No Comments/Clarification: Date the deviation was reported to the IRB (if applicable): Action taken to resolve this deviation (if any): Deviation impact (check all that apply): Study Validity Safety No Impact Outcome Measures Other, specify: Investigator Signature: Date: ______________ (dd/mmm/yyyy)
protocol-deviation-fillable-form.docx