Reportable Events and Incidents Training - PowerPoint Presentation

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Reportable Events and Incidents Training

SOP KP-502

Research Compliance Training

2012

KPSC

IRB Version 2-1

Dated

8/27/2015Slide2

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.Slide3

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

21 CFR 50, 56, 312, and 812Slide4

Course OutlineIntroductionEvents and Incidents Summary TableResponsibility for Identifying and Reporting Events and IncidentsReportable Events and IncidentsUnanticipated ProblemsAdverse Events/Serious Adverse EventsOther Possible Unanticipated ProblemsProtocol Violations and DeviationsOther Reportable Events and Incidents

Breach of Protected Health Information (PHI)Incarceration of a Study ParticipantNew Safety InformationEmergent ModificationsRegulatory Visits/InspectionsResourcesSlide5

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-502Determine 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 Slide6

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.Slide7

Events and Incidents Summary Table

Reportable Event or Incident

Report to IRBHow to Report

(Verify With Your Region)Breach of Protected Health Information

Immediately

report to Privacy Officer, IRB, and Lead Regional PI. Submit form to the IRB

within 10 business days

and at Continuing Review.

IMMEDIATELY

telephone and/or email Privacy Officer, IRB and Lead Regional PI.

Unanticipated Problem or Protocol Violation Report Form

Death

(participant in an interventional study) that is an Uananticipated Problem

Within 1 business day

following discovery and at continuing review

Internal Unanticipated Serious Adverse Event Report Form

Inspection by regulatory agency

Immediately

notify the Regional Research Director. Notify the IRB

within 2 business days

.

Telephone and/or email

Incarceration

of research participant

Within 2 business days

following discovery

Email

Emergent Modifications

Within 5 business days

of implementation

Emergent Modification 5 Day Report and Request

Internal Unanticipated Serious Adverse Events

Within 10 business days

following discovery and at continuing review

Internal Unanticipated Serious Adverse Event Report Form

External Unanticipated Serious Adverse Events

Within 10 business days

following discovery and at continuing review

External Unanticipated Serious Adverse Event Report Form

Other Unanticipated Problems

including those affecting individuals who are not research participants

Within 10 business days

following discovery and at continuing review

Unanticipated Problem Report Form

Unanticipated Adverse Device Effect

including effects experienced by Humanitarian Use Device (HUD) recipients as per SOP-020

Within 10 business days

following discovery and at continuing review

Unanticipated Adverse Device Effect Form;

Humanitarian Use Device(HUD) Adverse Device Effect Reporting Form

Protocol Violations and Non compliance

Within 10 business days

following discovery and at continuing review

Protocol Violation Report Form

New Safety Information

Within 10 business days

following discovery and at continuing review

Unanticipated Problem Report Form

PI and Sponsor disagree

on whether to report to the IRB

Within 10 business days

following discovery and at continuing review

Forward Any Reports or Correspondence

*IND Safety Reports & MedWatch Alerts

that are not Unanticipated Problems *External

At continuing review

Continuing Review Report

Protocol Deviations

At continuing review

Continuing Review Report

Death

(participant in an interventional study) that is not an Unanticipated Problem

At continuing review

Continuing Review Report*

*See KPSC SOP-031 and Continuing Review Report Form Question 6 for referenceSlide8

Principal InvestigatorResearch Team MembersInstitutional Review BoardResponsibility for Identifying and Reporting Events and IncidentsSlide9

Principal Investigator’s Responsibilities for ReportingProtect study participants’ rights, safety, and welfareDocument and manage potentially reportable events and incidentsCorrectly identify, analyze, and report events and incidents to the IRB in the specified timeframeEnsure that each Research Team Member obtains required training and understands how to identify, analyze, and report events and incidents to the PISlide10

Research Team Members’ Responsibilities for ReportingIdentify reportable events and incidentsImmediately contact the PI or his/her designee about any event or incident that could be reportableThe PI makes the ultimate determination if an event or incident is reportable to the IRBIf the PI or Sub-investigator is unavailable and you are concerned that an event could pose harm to a research participant, contact your regional IRBSlide11

The IRB Reports to the Following Entities as Required by Law or PolicyUS Department of Health and Human Services, Office of Human Research ProtectionsFDA (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 LeadershipRegional Research DirectorRegional Accountable OfficialRegional and/or local Research ChairPI’s Department ChairRegional PMG/KFHP/KFH Leaders Other Regional or Institutional OfficialsSlide12

The IRB May Take the Following Actions*Suspend or terminate the researchModify/monitor the research protocolModify/monitor the informed consent process and/or require re-consentNotify present and/or past study participantsConsult with other organizational entities (legal, risk management, compliance, privacy officer, etc.)Modify the Continuing Review scheduleGather information pending a final determinationOther actions as appropriate *SOP KP-003 IRB Reporting for Unanticipated Problems identifies the IRB follow-up process and requirementsSlide13

Reportable Events and IncidentsUnanticipated Problems Slide14

What is an Unanticipated Problem?When an event, incident or outcomemeets ALL three of the following criteriaIt is an Unanticipated ProblemUnexpected in nature, severity, or frequencyANDRelated or possibly related to participation in the researchAND

Suggests greater risk of harm to participant(s) or others than previously knownSlide15

Federal Regulations and KP Policy Require Reporting of Unanticipated ProblemsUnanticipated Problems represent 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 ReviewSlide16

Step 1. Determine if the event is UnexpectedStep 2. Determine if the event is Related or possibly relatedStep 3. Determine if the event Suggests greater risk

If an event is: Unexpected + Related or possibly related + Suggests greater risk = Reportable Unanticipated Problem

Three Steps to Identify an Unanticipated ProblemSlide17

Step 1: Determine if the Event is Unexpected The PI determines if the event or incident is unexpected in nature, severity, or frequency, taking into consideration: The protocol-related documents:IRB-approved research protocol or research applicationInformed consent documentsInvestigator brochureOther sources of information such as product labeling and package inserts

The PI’s knowledge of the characteristics of the study populationThe expected progression of any underlying diseases or conditions of the participantsThe participant’s pre-existing conditions and risk profile for the event Slide18

Step 1: Did Pre-existing Conditions Cause the Event? If the PI determines that a pre-existing condition(s) caused the event, the event is expected and is not an Unanticipated 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 medicationSubstance use/abuseEnvironmental influences or risks Do Not Report the Event to the IRBSlide19

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 PI Proceeds to Step ThreeSlide20

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 the participant, family members, Research Team Members, or others at greater risk of harm than was previously known by considering many factors including:Is there a greater physical risk of harm?Is there a greater psychological risk of harm?Is there a greater economic risk of harm?Is there a greater

social risk of harm?Slide21

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 ReviewSlide22

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 slideThe first 4 questions address a single event and the final 8 slides offer additional examplesSlide23

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) NoSlide24

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.Slide25

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) NoSlide26

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. Slide27

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) NoSlide28

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. Slide29

Unanticipated ProblemsQuestion 4 A defective investigational device caused serious harm to the investigator. Is this event a reportable Unanticipated Problem? A) Yes B) NoSlide30

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.

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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) NoSlide32

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.Slide33

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) NoSlide34

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.Slide35

Reportable Events and IncidentsAdverse Events Serious Adverse EventsSlide36

What is an Adverse Event? Adverse Events are unfavorable medical or psychological events experienced by a study participant during clinical research:A new symptomWorsening of an existing conditionA clinically significant abnormal lab findingSlide37

What is a Serious Adverse Event?Serious Adverse Events include:DeathLife threatening condition/situationNew or prolonged hospitalizationAn enduring or significant incapacity or substantial disruption of the ability to conduct normal life functionsThe delivery of a child with congenital anomaly or birth defectOther medical events that the PI determines require intervention to prevent the above outcomes Slide38

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 ReviewSlide39

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 ReviewSlide40

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 IRBSlide41

Analyzing Adverse EventsQuestion 1 Five interventional study participants develop severe anemia, requiring hospitalization.The consent form does not identify anemia as a study riskThe participants have no risk factors for anemiaNone 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.Slide42

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.Slide43

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. Slide44

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.Slide45

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 riskAfter 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.Slide46

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. Slide47

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 experiencingThe participant did not have any risk factors for kidney failureConduct 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.Slide48

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. Slide49

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 riskThe participants have no risk factors for a rashThree 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.Slide50

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.

Slide51

When PIs and Sponsors Disagree IND Safety Report (External Adverse Event) MedWatch Alert (External Adverse Event) Death of a Study Participant

Other Reportable Unanticipated ProblemsSlide52

When PIs and Sponsors Disagree The PI determines that an Adverse Event is not an Unanticipated Problem. The sponsor disagrees and notifies the PI, in writing, that the event is an Unanticipated Problem. The PI sends all reports and correspondence related to the Adverse Event to the IRB.Send Report to the IRB within 10 business days The IRB determines if follow-up action is required.Slide53

Example: When PIs and Sponsors Disagree A study participant experiences a nose bleed that lasts 2 hours. The PI reports this to the sponsor as an Adverse Event, but states that it does not place participants at greater risk and is not reportable as an Unanticipated Problem. The sponsor disagrees and wants the Adverse Event reported to the IRB. The PI sends all reports and correspondence related to the Adverse Event

to the IRB within 10 business days The IRB determines if follow-up action is required.Slide54

Reporting IND Safety Reports or MedWatch Alerts (External Adverse Events) Sponsors release an Investigational New Drug (IND) Safety Report to notify PIs and the FDA of an Adverse Event related to an investigational agent. The FDA releases MedWatch Alerts to provide new safety information for FDA approved drugs, medical devices, vaccines and other biologics. The PI conducts an independent analysis of the IND Safety Report and the MedWatch Alert. If the PI determines that the Adverse Event is an Unanticipated Problem, the PI reports to the IRB within 10 business days and at Continuing ReviewIf the PI determines that the Adverse Event is

not an Unanticipated Problem, the PI reports to the IRB at Continuing ReviewSlide55

Reporting the Death of a Participant Depends on Study Type and Unanticipated Problem Analysis1. Death of an Interventional Study Participant + Unanticipated Problem = Report to the IRB within 1 business day of discovery and at Continuing Review2. Death of an Interventional Study Participant + Not an Unanticipated Problem

= Report at Continuing Review3. Death of a Non-interventional Study Participant = Not ReportableSlide56

Reporting Time FramesQuestions and AnswersThe next 4 slides provide 2 examples. To determine the IRB reporting time frame consider: The type of study Whether the event is an Unanticipated Problem Slide57

Reporting Time FramesQuestion 1 An interventional study participant is a passenger in a car accident. She dies from her injuries. When does the PI report the death to the IRB? A) At the time of Continuing Review B) Within one business day of discovery and at Continuing Review C) The PI does not report the deathSlide58

Reporting Time Frames Answer 1When does the PI report the death to the IRB? A) At the time of Continuing Review The death occurred in an Interventional study and is not an Unanticipated Problem. The death does not meet all three criteria for an Unanticipated Problem. The death is not related to study participation.

The death does not suggest greater risk to other study participants. Slide59

Reporting Time FramesQuestion 2 An interventional study participant dies from kidney failure after taking the investigational drug.Kidney failure is not a known study riskThe participant had no risk factors for kidney failureWhen does the PI report the death to the IRB? A) At the time of Continuing Review B) Within one business day of discovery and at Continuing Review C) The PI does not report the deathSlide60

Reporting Time Frames Answer 2When does the PI report the death to the IRB? B) Within one business day of discovery and at Continuing Review The death occurred in an Interventional study and is an Unanticipated Problem. The death meets all three criteria for an Unanticipated Problem. The event is unexpected, related

to study participation and suggests greater risk to other study participants. Slide61

Reportable Events and Incidents Protocol Violations Protocol DeviationsSlide62

Report Protocol Violations A Protocol Violation is a departure from the IRB approved research plan that: Places the safety, rights, or welfare of one or more study participants at risk And/OrCould impact the integrity

of the studyReport Protocol Violations within 10 business days of discovery and at Continuing ReviewSlide63

Examples: Protocol ViolationsThe inclusion/exclusion criteria were not used correctly to include or exclude participants If study participants do not meet the inclusion criteria it could result in harm to the participants and/or impact the integrity of the studyThe PI used an old version of the consent form An old version of the consent form does not represent the current IRB approved form and may be missing important information. This could place the safety, rights, or welfare of study participants at risk and impact the integrity of the study

Report Protocol Violations within 10 business days of discovery and at Continuing ReviewSlide64

Additional Examples of Protocol Violations A Protocol Violation places the safety, rights, or welfare of one or more study participants at risk and/or impacts the integrity of the study.A participant received the incorrect study interventionA researcher did not obtain the participant’s signature and date on the consent form before initiating screening activitiesA research staff improperly dispensed an investigational agentMultiple incidents of protocol deviations reflect a pattern that constitute a Protocol ViolationSlide65

Report Protocol Deviations The PI determines if a protocol departure is a Violation or a Deviation. An incident that is a violation in one situation may be a deviation in another. A Protocol Deviation is a departure from the IRB approved research plan that: Does not place the safety, rights, or welfare of one or more study participants at riskAndDoes not impact the integrity of the study

Report Protocol Deviations at Continuing ReviewSlide66

Examples: Protocol DeviationsThe investigator conducts the procedure in the wrong sequence. The PI determines that: The change did not place the safety, rights, or welfare of study participants at risk AndDid not impact the integrity of the study

The investigator did not perform a required lab test. The PI determines that: The missing lab test did not place the safety, rights, or welfare of study participants at risk AndDid not impact the integrity of the studyReport Protocol Deviations at Continuing ReviewSlide67

Other Reportable Events and IncidentsBreach of Protected Health InformationIncarceration of a Study ParticipantNew Safety InformationEmergent ModificationsRegulatory Visits/InspectionsSlide68

Required Reporting of Breaches A Breach is the unauthorized acquisition, access, use, or disclosure of PHI that compromises privacy or security. There are numerous federal regulations that may apply to a breach, including the Common Rule, FDA regulations, Privacy Rule, Security Rule, CMS regulations, and others. Some of these regulations require KP to notify the appropriate regulatory agency within as soon as 24 hours following the discovery of the breach. Failure to report within the required time frame could result in significant fines for KP and possible civil and criminal penalties.Slide69

How to Report a Breach of PHI The PI reports a Breach:IMMEDIATELY by phone or email to the Regional Privacy and Security Officer, the IRB, and the Lead Regional PI for multi-region studiesTo the IRB as a Protocol Violation or an Unanticipated Problem within 10 business days and at Continuing Review

Note: Any breach of a Limited Data Set must be reported because it contains PHI. Slide70

Reporting a Breach to the IRB The PI reports a Breach to the IRB as a Protocol Violation or an Unanticipated Problem within 10 business days and at Continuing Review.A Protocol Violation places the safety, rights, or welfare of one or more study participants at risk and/or impacts the integrity of the studyAn Unanticipated Problem is unexpected, related or possibly related to participation in the research and suggests greater risk of harm to participants or othersSlide71

Report Participant Incarceration When a study participant is incarcerated, the participant’s status changes to “vulnerable population.”Additional federal regulations apply to vulnerable populationsStop all study interactions, interventions, and data collection Exception: The PI and IRB Chair may determine that it is in the participant’s best interest to continue in the study until other arrangements can be made.

Report participant incarceration to the IRB within 2 business days of discoverySlide72

Report New Safety Information that is an Unanticipated Problem The PI assesses New Safety Information to determine if it meets the three criteria of an Unanticipated Problem. Usually, New Safety Information reveals increased risk or reduced benefit to participants discovered during the course of the study.Report New Safety Information that is an Unanticipated Problem to the IRB

within 10 business daysand at Continuing ReviewSlide73

Report Emergent Modifications Emergent Modifications are changes made to the protocol or conduct of a study to protect the safety, rights, or welfare of research participants and/or others. When an immediate hazard exists, the PI may modify the research plan to protect the participants prior to receiving approval from the IRB. The PI takes the necessary action to protect the study participants and others.

Report to the IRB within 5 business days of implementation Emergent Modifications are RARE!Slide74

Report Regulatory Audits or InspectionsUnannounced or scheduled Audits or Inspections may occur at any time. Immediately notify the Regional Research DirectorReport to the IRB within 2 business days of notification Follow KP Policy when meeting auditors or inspectors.

Immediately ask for identificationProvide a place to wait until a department manager is availableDo not provide access to PHI or confidential business information, until an authorized individual has verified that the auditor or inspector has the right to access informationAlways treat the individual with courtesy and respect. If you are concerned that his/her behavior is inappropriate, contact building security.Slide75

ResourcesCopy and paste the URLs below into your browser.SOP KP-502, Version 1, Principal Investigator Reportable Event and Incident Requirements http://kpnet.kp.org/kfri/sops/all.htm Kaiser Foundation Research Institute and KP Regional Research Links http://kpnet.kp.org/kfri/about/index.htmReviewing and Reporting Unanticipated Problems and Adverse Events: On HHS YouTube Channel:

http://www.youtube.com/watch?v=hsUS0k3Ie_g Note: If your computer does not have the necessary KP intranet or internet access you will not be able to access the links above.Slide76

Congratulations!You have completed the course. Notify your Research Training Coordinator that you have completed the course.Click the X button in the upper right corner to close this window.Slide77

Kaiser Permanente Southern CaliforniaDocumentation of CompletionIn order to receive credit for completing this training, you must complete this page with your handwritten signature, indicating that you have read and understood the content of this Reportable Events and Incidents Research Compliance TrainingStep 1: Email a copy of this complete and signed Documentation of Completion Page in PDF format from your KP.ORG email to KPSC.IRB@kp.org.

Step 2: After two weeks, you must upload in iRIS the complete and signed Documentation of Completion Page in PDF format to your iRIS My Account Information, under Education History. If you are a new user, go to http://irissupport.kp-scalresearch.org/ to get a username and password. Click on the orange “new users” button located on the right hand side of your screen. If you already have an iRIS username and password

, log on to the iRIS home page http://iris.kp-scalresearch.org/.

KPSC IRB Version 2-1 Dated 8/27/2015

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