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Understanding Our HRPP and Your Role in the Accreditation Process.

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Presentation on theme: "Understanding Our HRPP and Your Role in the Accreditation Process."— Presentation transcript:

1 Understanding Our HRPP and Your Role in the Accreditation Process

2 Introduction Eugene Oddone, MD, Vice Dean for Research

3 3 What is AAHRPP? Association for the Accreditation of Human Research Protection Programs Gold standard for Human Research Protections programs is participation in a voluntary accreditation process. Independent, non-profit accrediting body that incorporates a voluntary, peer-driven, educational model to ensure that Dukes Human Research Protection Program (HRPP) meets rigorous standards for quality and protection Association for the Accreditation of Human Research Protection Programs Gold standard for Human Research Protections programs is participation in a voluntary accreditation process. Independent, non-profit accrediting body that incorporates a voluntary, peer-driven, educational model to ensure that Dukes Human Research Protection Program (HRPP) meets rigorous standards for quality and protection

4 4 Why is Duke Seeking Accreditation? The accreditation process allows us to take a comprehensive look at our HRPP in order to identify and address any weaknesses and build upon our strengths. It helps to ensure: The highest possible standards & protections An assurance of quality Improved efficiency & effectiveness A competitive edge Government recognition Public trust & confidence The accreditation process allows us to take a comprehensive look at our HRPP in order to identify and address any weaknesses and build upon our strengths. It helps to ensure: The highest possible standards & protections An assurance of quality Improved efficiency & effectiveness A competitive edge Government recognition Public trust & confidence

5 5 What is My Role in the Process? Investigators and their study teams are an important component of an HRPP Prepare for the site visit: Familiarize yourself with Dukes HRPP Review Dukes policies Know what resources are available to assist you If identified as a contact on the consent form, you may be called to determine if you are prepared to answer questions & if you respond in a reasonable amount of time. Investigators and their study teams are an important component of an HRPP Prepare for the site visit: Familiarize yourself with Dukes HRPP Review Dukes policies Know what resources are available to assist you If identified as a contact on the consent form, you may be called to determine if you are prepared to answer questions & if you respond in a reasonable amount of time.

6 Overview of AAHRPP Accreditation Wesley Byerly, PharmD, Associate Dean, Research Support Services Wesley Byerly, PharmD, Associate Dean, Research Support Services

7 7 Your Clinical Research Environment Your Human Subjects Good Clinical Practice: Regulations, Guidance, Policies & SOPs Duke HRPP Site Based Research Institutional (Duke) Policy Human Research Protection Programs (HRPP) AAHRPP Research Administration Offices

8 8 Good Clinical Practice (GCP) Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible ICH HARMONISED TRIPARTITE GUIDELINE, GUIDELINE FOR GOOD CLINICAL PRACTICE, E6 (http://www.ich.org/LOB/media/MEDIA482.pdf) Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible ICH HARMONISED TRIPARTITE GUIDELINE, GUIDELINE FOR GOOD CLINICAL PRACTICE, E6 (http://www.ich.org/LOB/media/MEDIA482.pdf)

9 9 Good Clinical Practice Detailed directions Professional Expectations of Practice Standards of Care Suggested ways to comply Guidances Mandatory requirements Regulations Prescribes obligations Laws Protect Subjects Goal Standard Operating Procedures ICH Guidelines

10 10 Which Regulations do you Follow? Department Health and Human Services (HHS) 45 CFR 46, Common Rule The Federal Policy for the protection of human subjects and is codified by a number of federal agencies. 45 CFR subpart B: Protection for Pregnant Women, Human Fetuses & Neonates 45 CFR subpart C: Protection for Prisoners 45 CFR subpart D: Protection for Children Federally Funded FDA Regulated Code of Federal Regulations (CFR) 21 Code of Federal Regulations (CFR) CFR Parts 50: Human Subject Protection 21 CFR Parts 50: Human Subject Protection CFR PART 54: Financial Disclosure 21 CFR PART 54: Financial Disclosure CFR 56: Institutional Review Boards 21 CFR 56: Institutional Review Boards CFR 312: Investigational New Drug 21 CFR 312: Investigational New Drug Application Application CFR 803,812: Devices 21 CFR 803,812: Devices Health Insurance Portability and Accountability Act (HIPAA) – Office of Civil Rights National Coverage Decision (NCD) –Office of Inspector General (OIG) VA Policies & Procedures 1 2

11 11 An integrated process where all the various components of an organization involved in the conduct of human research work together to protect the rights and welfare of participants Human Research Protections Program (HRPP) The HRPP is not an office. The HRPP is the collective effort of all who participate in the Conduct, Review, Approval and Facilitation of Clinical Research at Duke.

12 12 Goals of an HRPP Improve the systems that protect the rights and welfare of individuals who participate in research Communicate to the public the strength of an organization's commitment to the protection of human research participants Improve the overall quality of research by consistently applying high standards and practices, raising the global benchmark for human research protection Improve the systems that protect the rights and welfare of individuals who participate in research Communicate to the public the strength of an organization's commitment to the protection of human research participants Improve the overall quality of research by consistently applying high standards and practices, raising the global benchmark for human research protection

13 13 Conduct Where? Duke University Hospital Durham Regional Hospital Duke Raleigh Hospital By Whom? Investigators and Study Teams Review and Oversight Site-Based Research Units (SBRs) Institutional Review Board (IRB) and Subcommittees Clinical Research Support Office (CRSO) Clinical Trials Quality Assurance (CTQA) Privacy Office Research Integrity Office Information Security Office Sponsorship and Finance Office of Research Administration (ORA) Office of Corporate Research and Collaboration (OCRC) Office of Sponsored Programs (OSP) PRMO Clinical Trials Billing Office Research Costing & Compliance (RCC) 13

14 14 Association for the Accreditation of Human Research Protection Programs (AAHRPP) Step 2 A team of experts reviews the materials and sends report of changes to be made by institution to meet accreditation standards Step 2 A team of experts reviews the materials and sends report of changes to be made by institution to meet accreditation standards Step 1 Institution prepares and submits application with detailed policies, procedures, tools Step 1 Institution prepares and submits application with detailed policies, procedures, tools Step 3 (Currently at this step) Institution makes changes, AAHRPP schedules Site Visit to look at institution's HRPP performance with respect to accreditation standards Step 3 (Currently at this step) Institution makes changes, AAHRPP schedules Site Visit to look at institution's HRPP performance with respect to accreditation standards Step 5 AAHRPPs Council on Accreditation reviews the application, Site Visit Report and institutions response and determines sites accreditation status Step 5 AAHRPPs Council on Accreditation reviews the application, Site Visit Report and institutions response and determines sites accreditation status Step 4 Site Visit occurs: A report is received in 30 days and there is a response period

15 15 AAHRPP Accreditation Domains (What will be reviewed) Organization The entity that assumes responsibility for the Human Research Protection Program and applies for accreditation Research Review Unit Refers to the arrangements that the Organization has made for an independent review of ethical and scientific aspects of each research protocol involving human participants Investigator Includes the various arrangements that the Organization has made for assuring that individuals who plan to conduct research whether as a principal investigator, co- investigator, or other member of a research team understand and fulfill their responsibilities Sponsored Research Includes the Organizations arrangements for structuring its relationships with those who fund or initiate research external to the Organization, such as federal agencies, foundations, individual donors, and corporations Participant Outreach Refers to the arrangements the Organization has made for understanding the social, psychological, and physical needs and concerns of research participants and their communities Organization The entity that assumes responsibility for the Human Research Protection Program and applies for accreditation Research Review Unit Refers to the arrangements that the Organization has made for an independent review of ethical and scientific aspects of each research protocol involving human participants Investigator Includes the various arrangements that the Organization has made for assuring that individuals who plan to conduct research whether as a principal investigator, co- investigator, or other member of a research team understand and fulfill their responsibilities Sponsored Research Includes the Organizations arrangements for structuring its relationships with those who fund or initiate research external to the Organization, such as federal agencies, foundations, individual donors, and corporations Participant Outreach Refers to the arrangements the Organization has made for understanding the social, psychological, and physical needs and concerns of research participants and their communities

16 16 What Happens During the Site Visit? Twelve study team groups will be interviewed as representatives of our research community The interviews will last 45 minutes Groups will be either PI groups or coordinator groups Investigators will meet separately with the site visitors from the coordinators The CRSO will meet with these representatives of our study teams to assist them in preparing for the visit Site visitors will ask questions regarding our training resources, practices, procedures and processes For more information on the site visit, go to the CRSOs webpage on AAHRPP: http://crso.som.duke.edu/modules/crso_home/index.php?id=6 Twelve study team groups will be interviewed as representatives of our research community The interviews will last 45 minutes Groups will be either PI groups or coordinator groups Investigators will meet separately with the site visitors from the coordinators The CRSO will meet with these representatives of our study teams to assist them in preparing for the visit Site visitors will ask questions regarding our training resources, practices, procedures and processes For more information on the site visit, go to the CRSOs webpage on AAHRPP: http://crso.som.duke.edu/modules/crso_home/index.php?id=6

17 Dukes HRPP Jennifer Holcomb, Director of Operations, CRSO

18 18 Research Administration Offices CRSO Clinical Research Support Office IRB Institutional Review Board RIO Research Integrity Office OCRC Office of Corporate Research Collaboration ORA Office of Research Administration OSP Office of Sponsored Programs PRMO Patient Revenue Management Organization CTBO Clinical Trials Billing Office IDS Investigational Drug Service CTQA Clinical Trials Quality Assurance DUHS Compliance Duke University Health System Compliance CRSO Clinical Research Support Office IRB Institutional Review Board RIO Research Integrity Office OCRC Office of Corporate Research Collaboration ORA Office of Research Administration OSP Office of Sponsored Programs PRMO Patient Revenue Management Organization CTBO Clinical Trials Billing Office IDS Investigational Drug Service CTQA Clinical Trials Quality Assurance DUHS Compliance Duke University Health System Compliance

19 19 Site-Based Research Units (SBRs) 3 Unit Business Manager Department Chair CRSOFaculty Advisory Board CRCs Research Staff SBR Medical Director PIs Financial Manager Lead CRCs

20 20 What Role do SBRs and Study Teams Play in our HRPP? Policies, practices and procedures at the institutional (Duke), Site-Based Research Unit (SBR) and Study Team levels respectively, must be followed and reviewed, evaluated and revised regularly Communication between the Study Team and Research Administration is essential to Compliance with Regulations and Institutional Policies Policies, practices and procedures at the institutional (Duke), Site-Based Research Unit (SBR) and Study Team levels respectively, must be followed and reviewed, evaluated and revised regularly Communication between the Study Team and Research Administration is essential to Compliance with Regulations and Institutional Policies

21 21 SBR Functions Responsible for the integrity, financial accountability, regulatory compliance, quality, and academic productivity of the projects conducted in their groups Provide day-to-day management of site-based research activities including: Feasibility assessment of potential studies Study selection decisions Personnel management (hiring/supervision) of non- faculty research staff Protocol-specific training and study execution Financial management Responsible for the integrity, financial accountability, regulatory compliance, quality, and academic productivity of the projects conducted in their groups Provide day-to-day management of site-based research activities including: Feasibility assessment of potential studies Study selection decisions Personnel management (hiring/supervision) of non- faculty research staff Protocol-specific training and study execution Financial management

22 22 In addition to regulatory and DUHS requirements, Investigators are responsible for: Identifying and proposing studies Participating in the development of the Schedule of Events, budget, and billing grid Participating in negotiation with sponsors Following SBR Standard Operation Procedures (SOPs) The academic productivity of research Compliance with Duke HRPP training requirements - new on-line training modules taking effect Jan. 1, 2009 In addition to regulatory and DUHS requirements, Investigators are responsible for: Identifying and proposing studies Participating in the development of the Schedule of Events, budget, and billing grid Participating in negotiation with sponsors Following SBR Standard Operation Procedures (SOPs) The academic productivity of research Compliance with Duke HRPP training requirements - new on-line training modules taking effect Jan. 1, 2009 Site Based Research Investigator Responsibilities 645

23 23 Study Conduct and Management

24 24 Source Data (Documentation) All information in original records and certified copies of original records… (ICH GCP 1.51) Includes Clinical findings Observations Other study activities Necessary for: The reconstruction and evaluation of the study Confirmation of subject existence and observations Substantiation of study data integrity Source Document: A record which contains ORIGINAL source data (e.g. Medical records, Lab reports, X-rays, ECGs, Intake/ Screening forms, Telephone contact records, faxes, e-mails, Subject diaries, Informed consent forms, CRFS) Source Data (Documentation) All information in original records and certified copies of original records… (ICH GCP 1.51) Includes Clinical findings Observations Other study activities Necessary for: The reconstruction and evaluation of the study Confirmation of subject existence and observations Substantiation of study data integrity Source Document: A record which contains ORIGINAL source data (e.g. Medical records, Lab reports, X-rays, ECGs, Intake/ Screening forms, Telephone contact records, faxes, e-mails, Subject diaries, Informed consent forms, CRFS) Managing Approved Studies: Documentation – What & Why

25 25 Note/Memo to File Used to clarify missing or inaccurate data or procedures. Store memo in the appropriate regulatory binder and with the source documentation. Not a panacea for all things that have gone wrong. Document problem –Not enough. Document problem -> document corrective action identified for preventing recurrence -> institute corrective action Examples: An assessment is missed or completed out of sequence Are unable to obtain a blood sample at a visit A subject failed to initial one page of a consent document If an original document is destroyed and only a copy remains A subject is lost to follow-up A subject is dropped from the study Note/Memo to File Used to clarify missing or inaccurate data or procedures. Store memo in the appropriate regulatory binder and with the source documentation. Not a panacea for all things that have gone wrong. Document problem –Not enough. Document problem -> document corrective action identified for preventing recurrence -> institute corrective action Examples: An assessment is missed or completed out of sequence Are unable to obtain a blood sample at a visit A subject failed to initial one page of a consent document If an original document is destroyed and only a copy remains A subject is lost to follow-up A subject is dropped from the study Managing Approved Studies: Documentation – What & Why

26 26 Drugs/Biologics: 2 years following the date of market application approval, market application non-approval or discontinuation of the investigation (21 CFR 312.62[c]) Devices: For a period of 2 years after the latter of the following investigation termination/completion date, or date that records no longer required to support premarket approval application (21 CFR 812.140[d]) FYI - ICH Guidelines: 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. (ICH GCP (E6), 4.9.5) Drugs/Biologics: 2 years following the date of market application approval, market application non-approval or discontinuation of the investigation (21 CFR 312.62[c]) Devices: For a period of 2 years after the latter of the following investigation termination/completion date, or date that records no longer required to support premarket approval application (21 CFR 812.140[d]) FYI - ICH Guidelines: 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. (ICH GCP (E6), 4.9.5) Managing Approved Studies: Record Retention – Quick Takes

27 27 Study Conduct & Subject Protection How do Privacy and Confidentiality Differ? Privacy is about protecting the person Confidentiality is about protecting the private information (DATA) you have access to How do Privacy and Confidentiality Differ? Privacy is about protecting the person Confidentiality is about protecting the private information (DATA) you have access to

28 28 Do not cold contact subjects When designing the recruitment process, remember that the study must be introduced by healthcare personnel known to the potential subject. If the subject indicates interest in the study, then research personnel may approach the subject to discuss the study further. Ensure interviews are convened in a private setting If others are present, ensure that their presence is appropriate Consider how the subject might like to be treated given their age, ethnicity, or gender Do not cold contact subjects When designing the recruitment process, remember that the study must be introduced by healthcare personnel known to the potential subject. If the subject indicates interest in the study, then research personnel may approach the subject to discuss the study further. Ensure interviews are convened in a private setting If others are present, ensure that their presence is appropriate Consider how the subject might like to be treated given their age, ethnicity, or gender Study Conduct & Subject Protection: How do I Maintain the Privacy of my Subjects?

29 29 Refers to the protections that you provide for private information Expectation that data will not be divulged except in ways previously agreed upon It's about DATA verbal written electronic Refers to the protections that you provide for private information Expectation that data will not be divulged except in ways previously agreed upon It's about DATA verbal written electronic Study Conduct & Subject Protection: Protecting Confidentiality

30 30 Does your subject have an expectation that information provided will be kept confidential? How do you identify potential subjects? What data are you collecting? Is the information you are recording of a personal nature? Are you recording information about a third party? How are the data going to be stored? Who is going to have access to the data? Does your subject have an expectation that information provided will be kept confidential? How do you identify potential subjects? What data are you collecting? Is the information you are recording of a personal nature? Are you recording information about a third party? How are the data going to be stored? Who is going to have access to the data? Study Conduct & Subject Protection: Protecting Confidentiality

31 31 There are tools to protect it both inside and outside of Duke HIPAA: Set of tools (and rules) for maintaining confidentiality now and after disclosure (commonly referred to as the Privacy Rule) Certificate of Confidentiality: Allows you to keep the data away from outsiders; even from a court order (Applies to any research, not just NIH funded) There are tools to protect it both inside and outside of Duke HIPAA: Set of tools (and rules) for maintaining confidentiality now and after disclosure (commonly referred to as the Privacy Rule) Certificate of Confidentiality: Allows you to keep the data away from outsiders; even from a court order (Applies to any research, not just NIH funded) 7 Study Conduct & Subject Protection: Protecting Confidentiality

32 32 How is equitable selection operationalized? Who has first contact with prospective participants? When is it appropriate to approach a family member or friend first? Is it acceptable to leave a consent with the medical provider to pass on? How is first contact made? How is equitable selection operationalized? Who has first contact with prospective participants? When is it appropriate to approach a family member or friend first? Is it acceptable to leave a consent with the medical provider to pass on? How is first contact made? Study Conduct & Subject Protection: Recruitment – The Foundation of Informed Consent

33 33 Study Conduct & Subject Protection: Do You Have Informed Consent? When does Informed consent begin…end? What do you assess to determine the individual's capability to provide legally effective informed consent? What criteria should be in place to ensure you have informed consent? When does Informed consent begin…end? What do you assess to determine the individual's capability to provide legally effective informed consent? What criteria should be in place to ensure you have informed consent?

34 34 *Indications of potentially diminished capacity are: A diagnosis of dementia or cognitive impairment Presenting for an evaluation of dementia A report, in medical records or from a family member or person well acquainted with the subject, that the subject has symptoms of cognitive impairment or dementia An abnormal degree of confusion, forgetfulness, or difficulties in communication that is observed in the course of interacting with the subject Psychotic symptoms, bizarre or abnormal behavior exhibited by the subject For research that may involve subjects with diminished capacity to make an informed decision, you need to inform the IRB of: What special protections will you ensure are in place? Who will assess for decisional capacity? When will this occur? Under what circumstances will reassessment occur? What provisions will be made to obtain the consent of the research subject if the period of diminished capacity is temporary? *UC Davis Alzheimer's Disease Center *Indications of potentially diminished capacity are: A diagnosis of dementia or cognitive impairment Presenting for an evaluation of dementia A report, in medical records or from a family member or person well acquainted with the subject, that the subject has symptoms of cognitive impairment or dementia An abnormal degree of confusion, forgetfulness, or difficulties in communication that is observed in the course of interacting with the subject Psychotic symptoms, bizarre or abnormal behavior exhibited by the subject For research that may involve subjects with diminished capacity to make an informed decision, you need to inform the IRB of: What special protections will you ensure are in place? Who will assess for decisional capacity? When will this occur? Under what circumstances will reassessment occur? What provisions will be made to obtain the consent of the research subject if the period of diminished capacity is temporary? *UC Davis Alzheimer's Disease Center Study Conduct & Subject Protection: Diminished Capacity/Cognitive Impairment

35 35 Study Conduct & Subject Protection: Diminished Capacity/Cognitive Impairment Considerations for the Informed Consent Process Determining extent of cognitive impairment Will the individual have enough information to make an informed decision? Will the individual be able to make a decision? Will the individual understand the consequences of the decision? Will the individual be able to communicate the decision? Will the subject need a legally authorized representative to act on behalf of the subject? Will assent be sought? Circumstances under which the subjects failure to assent can be overridden by the subjects legally authorized representative Periodic reassessment of the subjects cognition – will it be necessary? If yes, when it will occur, and by whom? Will the subject will be asked to consent for continued study participation if the subjects decisional capacity improves, and if not, why not? Considerations for the Informed Consent Process Determining extent of cognitive impairment Will the individual have enough information to make an informed decision? Will the individual be able to make a decision? Will the individual understand the consequences of the decision? Will the individual be able to communicate the decision? Will the subject need a legally authorized representative to act on behalf of the subject? Will assent be sought? Circumstances under which the subjects failure to assent can be overridden by the subjects legally authorized representative Periodic reassessment of the subjects cognition – will it be necessary? If yes, when it will occur, and by whom? Will the subject will be asked to consent for continued study participation if the subjects decisional capacity improves, and if not, why not?

36 36 1.Court-approved guardian 2.Health care agent 3.Spouse 4.Adult son and/or daughter 5.Parent 6.Adult brother and/or sister 7.Uncle and/or aunt 8.Other adult kin 1.Court-approved guardian 2.Health care agent 3.Spouse 4.Adult son and/or daughter 5.Parent 6.Adult brother and/or sister 7.Uncle and/or aunt 8.Other adult kin Study Conduct & Subject Protection: N.C. Order of Authority for Serving as a Legally Authorized Representative (LAR)

37 37 Subjects with Diminished Capacity/Cognitive Impairment – IRB does not have specific policies regarding assent for this population Children In NC residents under 18 years of age are considered minors in unless they are "emancipated" by court order In determining whether children are capable of assenting, the IRB will take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate Age related IRB consent requirements > 6 years of age should be involved in the decision to participate in a research project 12 years of age must sign assent after the parent or legal guardian has given consent (for exceptions consult IRB manual) Subjects with Diminished Capacity/Cognitive Impairment – IRB does not have specific policies regarding assent for this population Children In NC residents under 18 years of age are considered minors in unless they are "emancipated" by court order In determining whether children are capable of assenting, the IRB will take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate Age related IRB consent requirements > 6 years of age should be involved in the decision to participate in a research project 12 years of age must sign assent after the parent or legal guardian has given consent (for exceptions consult IRB manual) Study Conduct & Subject Protection: Assent – Diminished Capacity & Children

38 38 Document that the Subject was given a (signed) copy of the ICF in the case history If subject is a patient, DUHS requires a copy of the consent form in the subjects DUHS medical record (JCAHO requirement) Best Practice: Document the consent process in the case history & the medical record Include: IRB approval obtained prior to subject consenting How subject was informed (read consent, discussion, Q&A, video) Who participated in the consent process and how (investigator, study coordinator, legal authorized representative, family, etc.) How subjects understanding of the information was assessed Disposition of the signed consent form (original and copies) Special or unusual circumstances (e.g. Illiterate subject –how did you ensure the subject was informed and that your process met regulatory requirements?) Document that the Subject was given a (signed) copy of the ICF in the case history If subject is a patient, DUHS requires a copy of the consent form in the subjects DUHS medical record (JCAHO requirement) Best Practice: Document the consent process in the case history & the medical record Include: IRB approval obtained prior to subject consenting How subject was informed (read consent, discussion, Q&A, video) Who participated in the consent process and how (investigator, study coordinator, legal authorized representative, family, etc.) How subjects understanding of the information was assessed Disposition of the signed consent form (original and copies) Special or unusual circumstances (e.g. Illiterate subject –how did you ensure the subject was informed and that your process met regulatory requirements?) Study Conduct & Subject Protection: Documenting Informed Consent

39 39 Study Conduct & Subject Protection: Unanticipated Problems vs. Adverse Events Most adverse events are not unanticipated problems Unanticipated problems include other incidents, experiences, and outcomes not considered adverse events Adverse Events Unanticipated Problems SAEs Unanticipated Problems (including SAEs and AEs) involving new or increased risk Require prompt reporting to the IRB, and sponsor, if applicable, and the FDA, if applicable.

40 40 Study Conduct & Subject Protection: Medical Devices, Adverse Events and Effects Unreasonable Risk Serious & Unanticipated Device Related Adverse Effect Record & Document 21 CFR 812.140(a)(3)(ii) Report to sponsor & IRB within 10 days 812.150(a)(1) 8 (Sponsor Obligation) Investigator Reporting Requirements

41 41 Types of Departures Deviation – Unintentional Violation – Intentional Departures must be reported when the following are impacted: Rights, welfare or safety of subject Integrity of the research data Subjects willingness to continue study Forms to use Notification of Protocol Deviation/Violation If departure is both unanticipated and meets above criteria, the Notification of a Problem or Event requiring Prompt reporting to the IRB as a New or Increased Risk must also be submitted to IRB Types of Departures Deviation – Unintentional Violation – Intentional Departures must be reported when the following are impacted: Rights, welfare or safety of subject Integrity of the research data Subjects willingness to continue study Forms to use Notification of Protocol Deviation/Violation If departure is both unanticipated and meets above criteria, the Notification of a Problem or Event requiring Prompt reporting to the IRB as a New or Increased Risk must also be submitted to IRB Managing Approved Studies: Protocol Departures, a.k.a. Noncompliance


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