Keyword: Date: Initial Report: Follow-up Report: INSTITUTIONAL REVIEW BOARD DEVIATION and NONCOMPLIANCE REPORT FORM (Version 04/09) 1 copy of this form must be submitted electronically or typed for submission to PH IRB. Emergency Protocol Deviations must be reported within five (5) business days of the event. All other Deviations or Noncompliance must be reported within ten (10) business days of discovery of the event. This Report involves a: (Please check all that apply): Deviation: A failure, whether intended or unintended, to follow the PH IRB approved Protocol. Emergency Protocol Deviation: A Deviation that is necessary to eliminate apparent immediate hazards to the subject as determined by the Investigator or Sponsor. Noncompliance: A failure, whether intended or unintended, to follow federal regulations, or the requirements and determinations or policies and procedures of PH IRB. Principal Investigator: Study Coordinator: Protocol #: Title of Protocol: Patient Initials: Date of Occurrence: Patient Study #: Date Site Notified of, or Discovered, Deviation or Noncompliance: Describe the Deviation and/or Noncompliance (Explain why/how the incident occurred): 2. Describe corrective action(s) taken in this occurrence: 3. Describe plan of action to prevent future occurrences: 4. Did this incident result in a Serious Adverse Event? Yes No NA 4a. If Yes, please explain briefly: (Also file , if applicable) 5. Was there any impact on subject safety? Yes Possibly No Unknown 5a. If Yes, or Possible, please explain briefly: 6. Will the subject remain in the study? Yes No NA 7. Was the Sponsor notified? Yes No NA 8. Additional Comments (if any): ____________________________________________ ____________________________ Principal Investigator or Designee Date
Keyword: Date: Initial Report: Follow-up Report: INSTITUTIONAL REVIEW BOARD DEVIATION and NONCOMPLIANCE REPORT FORM (Version 04/09) 1 copy of this form must be submitted electronically or typed for submission to PH IRB. Emergency Protocol Deviations must be reported within five (5) business days of the event. All other Deviations or Noncompliance must be reported within ten (10) business days of discovery of the event. This Report involves a: (Please check all that apply): Deviation: A failure, whether intended or unintended, to follow the PH IRB approved Protocol. Emergency Protocol Deviation: A Deviation that is necessary to eliminate apparent immediate hazards to the subject as determined by the Investigator or Sponsor. Noncompliance: A failure, whether intended or unintended, to follow federal regulations, or the requirements and determinations or policies and procedures of PH IRB. Principal Investigator: Study Coordinator: Protocol #: Title of Protocol: Patient Initials: Date of Occurrence: Patient Study #: Date Site Notified of, or Discovered, Deviation or Noncompliance: Describe the Deviation and/or Noncompliance (Explain why/how the incident occurred): 2. Describe corrective action(s) taken in this occurrence: 3. Describe plan of action to prevent future occurrences: 4. Did this incident result in a Serious Adverse Event? Yes No NA 4a. If Yes, please explain briefly: (Also file , if applicable) 5. Was there any impact on subject safety? Yes Possibly No Unknown 5a. If Yes, or Possible, please explain briefly: 6. Will the subject remain in the study? Yes No NA 7. Was the Sponsor notified? Yes No NA 8. Additional Comments (if any): ____________________________________________ ____________________________ Principal Investigator or Designee Date
PH%20IRB%20P_P%20Deviation%20and%20Noncompliance%20Report%20Form%2004-2009rev_1.docx