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Reportable Events and Incidents Training SOP KP-502

Reportable Events and Incidents Training SOP KP-502. Research Compliance Training. 2012. KPSC Version 2 Dated 8/15/2012. Required Training. The training takes approximately 1 hour. All Research Team Members who contribute to the conduct of research must complete the training, including:

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Reportable Events and Incidents Training SOP KP-502

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  1. Reportable Events and Incidents Training SOP KP-502 Research Compliance Training 2012 KPSC Version 2 Dated 8/15/2012

  2. Required Training The training takes approximately 1 hour. All Research Team Members who contribute to the conduct of research must complete the training, including: • Principal Investigators (PIs), Sub-investigators, Research Managers/Coordinators, Nurses, and others as determined by the PI (e.g., Research Assistants, Medical Assistants, Pharmacists, Data Analysts, etc.) This training focuses on reporting events and incidents to the Institutional Review Board (IRB). It does not cover the PI’s reporting requirements to external sponsors. Note: This training does not apply to Emergency Use or Humanitarian Use Device research.

  3. Federal Regulations This training supports SOP KP-502, Principal Investigator Reportable Event and Incident Requirements. SOP KP-502is written to comply with federal reporting regulations including: • U.S. Department of Health and Human Services 45 CFR 46 • U.S. Department of Health and Human Services 45 CFR 164 • U.S. Food and Drug Administration 21 CFR 50, 56, 312, and 812

  4. Course Outline Introduction Events and Incidents Summary Table Responsibility for Identifying and Reporting Events and Incidents Reportable Events and Incidents • Unanticipated Problems • Adverse Events/Serious Adverse Events • Other Possible Unanticipated Problems • Protocol Violations and Deviations • Other Reportable Events and Incidents • Breach of Protected Health Information (PHI) • Incarceration of a Study Participant • New Safety Information • Emergent Modifications • Regulatory Visits/Inspections Resources

  5. Purpose By the end of the training you should be able to: • Analyze an event or incident to determine if it is reportable according to SOP KP-502 • Determine if an event meets the three criteria defining an “unanticipated problem” • Understand your responsibility as a PI or Research Team Member to identify, analyze, and report events and incidents • Identify resources to help you comply with SOP KP-502

  6. Print Summary Table The table on the next slide (slide 7) summarizes reportable events and incidents, reporting time frames, and reporting methods. Print the table to use as a reference during the training.

  7. Responsibility for Identifying and Reporting Events and Incidents Principal InvestigatorResearch Team MembersInstitutional Review Board

  8. Principal Investigator’s Responsibilities for Reporting • Protect study participants’ rights, safety, and welfare • Document and manage potentially reportable events and incidents • Correctly identify, analyze, and report events and incidents to the IRB in the specified timeframe • Ensure that each Research Team Member obtains required training and understands how to identify, analyze, and report events and incidents to the PI

  9. Research Team Members’ Responsibilities for Reporting • Identify reportable events and incidents • Immediately contact the PI or his/her designee about any event or incident that could be reportable • The PI makes the ultimate determination if an event or incident is reportable to the IRB • If the PI or Sub-investigator is unavailable and you are concerned that an event could pose harm to a research participant, contact your regional IRB

  10. US Department of Health and Human Services, Office of Human Research Protections FDA (for FDA regulated studies) Federalwide Assurance Official at KFRI (Vice President and Director of KFRI) Program Officer or Grant Manager (for federally funded studies) Regional Research Leadership Regional Research Director Regional Accountable Official Regional and/or local Research Chair PI’s Department Chair Regional PMG/KFHP/KFH Leaders Other Regional or Institutional Officials The IRB Reports to the Following Entities as Required by Law or Policy

  11. The IRB May Take the Following Actions* • Suspend or terminate the research • Modify/monitor the research protocol • Modify/monitor the informed consent process and/or require re-consent • Notify present and/or past study participants • Consult with other organizational entities (legal, risk management, compliance, privacy officer, etc.) • Modify the Continuing Review schedule • Gather information pending a final determination • Other actions as appropriate *SOP KP-003 IRB Reporting for Unanticipated Problems identifies the IRB follow-up process and requirements

  12. Reportable Events and Incidents Unanticipated Problems

  13. What is an Unanticipated Problem? When an event, incident or outcome meets ALL three of the following criteria It is an Unanticipated Problem • Unexpected in nature, severity, or frequency AND • Related or possibly related to participation in the research AND • Suggests greater risk of harm to participant(s) or others than previously known

  14. Federal Regulations and KP Policy Require Reporting of Unanticipated Problems • Unanticipated Problemsrepresent a risk of harm that is unexpected and possibly related to the study • The risk of harm may affect study participant(s) and/or others including: family members, Research Team Members, hospital staff, clinical staff, or others as determined by the PI • The PI must take action to protect the study participant(s) or others from the unexpected risk of harm Report Unanticipated Problems to the IRB within 10 Business Days of discovery and at Continuing Review

  15. Three Steps to Identify an Unanticipated Problem Step 1.Determine if the event isUnexpected Step 2.Determine if the event isRelated or possibly related Step 3.Determine if the eventSuggests greater risk If an event is: Unexpected + Related or possibly related + Suggests greater risk = Reportable Unanticipated Problem

  16. Step 1:Determine if the Event is Unexpected The PI determines if the event or incident isunexpected in nature, severity, or frequency, taking into consideration: • The protocol-related documents: • IRB-approved research protocol or research application • Informed consent documents • Investigator brochure • Other sources of information such as product labeling and package inserts • The PI’s knowledge of the characteristics of the study population • The expected progression of any underlying diseases or conditions of the participants • The participant’s pre-existing conditions and risk profile for the event

  17. Step 1: Did Pre-existing Conditions Cause the Event? If the PI determines that a pre-existing condition(s) caused theevent, the event is expected and is notanUnanticipated Problem. Does the participant’s clinical history indicate pre-existing conditions or risk factors? For example: • Clinical conditions such as diabetes, coronary disease, hypertension, pulmonary disease, etc. • Side-effects or interactions with drugs other than the study medication • Substance use/abuse • Environmental influences or risks Do Not Report the Event to the IRB

  18. Step 2: If Unexpected, Determine if Related or Possibly Related The PI determines if the event is related or possibly related to the research by considering many factors including: • Did the event occur close in time to the research intervention (drug, device, behavioral)? • Did more than one participant experience the event? • Did the event stop or lessen when the intervention was discontinued? If the PI determines the event is related or possibly related to the research, The PIProceeds to Step Three

  19. Step 3: If Unexpected and Related to the Research, Determine if the Event Suggests Greater Risk The PI determines if the event or incident could place theparticipant, family members, Research Team Members, or others atgreater risk of harmthan was previously known by considering many factors including: • Is there a greater physicalrisk of harm? • Is there a greater psychological risk of harm? • Is there a greater economic risk of harm? • Is there a greater socialrisk of harm?

  20. Did the Event Meet All Three Criteria for an Unanticipated Problem? Unexpected + Related or possibly related + Suggests greater risk to participants or others = A Reportable Unanticipated Problem Report to the IRB within 10 business days and at Continuing Review

  21. Unanticipated ProblemsQuestions and Answers The next 12 slides provide examples and walk through the process of determining if an event is a reportable Unanticipated Problem. • The question appears on the first slide and the answer, with a brief explanation, appears on the second slide • The first 4 questions address a single event and the final 8 slides offer additional examples

  22. Unanticipated ProblemsQuestion 1 The first four questions address this event. A defective investigational device caused serious harm to the investigator. The PI analyzes this event to determine if it is reportable. Step 1. Is this event unexpected? A) Yes B) No

  23. Unanticipated ProblemsAnswer 1 Step 1. Is this event unexpected? A) Yes, this event is unexpected. The investigator did not expect the device to be defective.

  24. Unanticipated ProblemsQuestion 2 A defective investigational device caused serious harm to the investigator. The PI determined the event is unexpected. Step 2. Is this event related or possibly related to the research? A) Yes B) No

  25. Unanticipated ProblemsAnswer 2 Step 2. Is this event related or possibly related to the research? A) Yes, this event is related to the research. The investigational device is being used for the research study.

  26. Unanticipated ProblemsQuestion 3 A defective investigational device caused serious harm to the investigator. The PI determined the event is unexpected and related to the research. Step 3. Does this event suggest greater risk of harm to participants or others than was previously known? A) Yes B) No

  27. Unanticipated ProblemsAnswer 3 Step 3. Does this event suggest greater risk of harm to participants or others than was previously known? A) Yes, this event suggests greater risk to participants or others – in this case the investigator.

  28. Unanticipated ProblemsQuestion 4 A defective investigational device caused serious harm to the investigator. Is this event a reportable Unanticipated Problem? A) Yes B) No

  29. Unanticipated ProblemsAnswer 4 Is this event a reportable Unanticipated Problem? A) Yes, this event is an Unanticipated Problem. It is unexpected, related or possibly related to the research, and suggests greater risk of harm to participants or others than previously known. The PI reports an Unanticipated Problem within 10 business days and at Continuing Review.

  30. Unanticipated ProblemsQuestion 5 A study participant’s 3 year-old took the study medication and became listless and unresponsive. Does the PI report this event to the IRB as an Unanticipated Problem? A) Yes B) No

  31. Unanticipated ProblemsAnswer 5 Does the PI report this event to the IRB as an Unanticipated Problem? A) Yes, this is an Unanticipated Problem because it is unexpected, related to study participation, and suggests greater risk to participants or others – in this case the 3 year-old. The PI reports Unanticipated Problems to the IRB within 10 days and at Continuing Review.

  32. Unanticipated ProblemsQuestion 6 A Research Team Member experiences a study related needle stick. The study participant has hepatitis C. Does the PI report this event to the IRB as an Unanticipated Problem? A) Yes B) No

  33. Unanticipated ProblemsAnswer 6 Does the PI report this event to the IRB as an Unanticipated Problem? A) Yes, this is an Unanticipated Problem because it is unexpected, related to study participation, and suggests greater risk to participants or others – in this case the Research Team Member. The PI reports Unanticipated Problems to the IRB within 10 days and at Continuing Review.

  34. Reportable Events and Incidents Adverse Events Serious Adverse Events

  35. What is an Adverse Event? Adverse Events are unfavorable medical or psychological events experienced by a study participant during clinical research: • A new symptom • Worsening of an existing condition • A clinically significant abnormal lab finding

  36. What is a Serious Adverse Event? Serious Adverse Eventsinclude: • Death • Life threatening condition/situation • New or prolonged hospitalization • An enduring or significant incapacity or substantial disruption of the ability to conduct normal life functions • The delivery of a child with congenital anomaly or birth defect • Other medical events that the PI determines require intervention to prevent the above outcomes

  37. Report Only Adverse Events that are Unanticipated Problems Adverse Events are not reportable to the IRB unless they meet all three criteria for an Unanticipated Problem. Unexpected + Related or possibly related + Suggests greater risk to participants or others = A Reportable Unanticipated Problem Report to the IRB within 10 business days and at Continuing Review

  38. Report Adverse Events Requiring Significant Modification If the PI determines that an Adverse Event or Serious Adverse Event requires significant modification to the brochure, study protocol, or informed consent, to ensure patient safety – it is an Unanticipated Problem. Report to the IRB within 10 business days and at Continuing Review

  39. Analyzing Adverse EventsQuestions and Answers The next 10 slides include five examples of Adverse Events or Serious Adverse Events. • Using what you know about Unanticipated Problems, analyze each event to determine if it should be reported to the IRB

  40. Analyzing Adverse EventsQuestion 1 Five interventional study participants develop severe anemia, requiring hospitalization. • The consent form does not identify anemia as a study risk • The participants have no risk factors for anemia • None of the control group participants have shown evidence of anemia Conduct your analysis of this event. Would the PI report to the IRB? A) No. The PI would not report because the event was expected. It does not meet all three criteria for an Unanticipated Problem. B) Yes. The PI reports the event because it meets all three criteria of an Unanticipated Problem.

  41. Analyzing Adverse EventsAnswer 1 Would the PI report to the IRB? B) Yes. The PI reports the event because it meets all three criteria of an Unanticipated Problem and should be reported to the IRB within 10 business days and at Continuing Review. The consent form does not mention anemia, and the participants do not have risk factors for anemia. The event is unexpected. Multiple participants experienced the same event. There is no anemia in the control group. The event is possibly related to the research. Hospitalization and severe anemia in five participants suggests greater risk to participants.

  42. Analyzing Adverse EventsQuestion 2 In a psychology study, participants are in a small, windowless, soundproof booth. One participant experiences claustrophobia while in the booth. • The consent form describes claustrophobic reactions as one of the study risks Conduct your analysis of this event. Would the PI report to the IRB? A) Yes. The adverse event is expected + related + suggests greater risk. B) Yes. The adverse event is unexpected + related + suggests greater risk. C) No. The adverse event is expected + related + does not suggest greater risk.

  43. Analyzing Adverse EventsAnswer 2 Would the PI report to the IRB? C) No. The adverse event is expected + related + does not suggest greater risk. The PI does not report as an Unanticipated Problem. The event is expected because the informed consent describes claustrophobic reactions as one of the study risks. The proximity in time indicates that the event is related to study participation. The event does not suggest greater risk than previously known. Claustrophobia was an expected risk identified in the consent form.

  44. Analyzing Adverse EventsQuestion 3 Three of the first ten study participants develop severe gastroesophageal reflex disease (GERD) within one week of beginning the study. • The consent form does not identify GERD as a study risk • After the drug is discontinued, the GERD symptoms resolve Conduct your analysis of this event. Would the PI report to the IRB? A) Yes. The event is expected + related + suggests greater risk. B) Yes. The event is unexpected + related + suggests greater risk. C) No. The event is expected + related + suggests no greater risk.

  45. Analyzing Adverse EventsAnswer 3 Would the PI report to the IRB? B) Yes. The event is unexpected + related + suggests greater risk. The PI reports an Unanticipated Problem within 10 days and at Continuing Review. The consent form does not mention GERD. The event is unexpected. Several factors suggest that event is related to the research: proximity in time, 3 participants experienced the event, and the symptoms resolved after the drug was discontinued. The GERD symptoms are severe, this suggests greater risk to study participants.

  46. Analyzing Adverse EventsQuestion 4 One of the study participants required hospitalization from kidney failure after beginning the study. • The consent form mentions possible kidney problems, but not the level of severity the participant is experiencing • The participant did not have any risk factors for kidney failure Conduct your analysis of this event. Would the PI report to the IRB? A) Yes. The event is expected + related + suggests greater risk. B) Yes. The event is unexpected + related + suggests greater risk. C) No. The event is expected + related + suggests no greater risk.

  47. Analyzing Adverse EventsAnswer 4 Would the PI report to the IRB? B) Yes. The event is unexpected + related + suggests greater risk. The PI reports an Unanticipated Problem within 10 days and at Continuing Review. The event is unexpected because it is more frequent or severe than the description in the consent form. The event is possibly related because the participant had no risk factors for kidney failure. The severity of the event suggests greater risk to study participants.

  48. Analyzing Adverse EventsQuestion 5 Three experimental group participants develop a rash that lasts for 3 hours. • The consent form does not mention a rash as a study risk • The participants have no risk factors for a rash • Three control group participants also develop a rash Conduct your analysis of this event. Would the PI report to the IRB? A) Yes. The event is expected + related + suggests greater risk. B) No. The event is unexpected + not related + suggests no greater risk. C) Yes. The event is unexpected + related + suggests greater risk.

  49. Analyzing Adverse EventsAnswer 5 Would the PI report to the IRB? B) No. The event is unexpected + not related + suggests no greater risk. The PI does not report as an Unanticipated Problem. The event is unexpected because the consent form does not identify a rash as a risk and the participants do not have risk factors for a rash. The PI’s analysis indicates that the event is not related to study participation because three control group members also experienced a rash. The rashes are not serious and do not suggests greater risk to study participants.

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