CITI Programa de Educación en Ética de la Investigación

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1 Universidad Nacional Autónoma de Honduras Facultad de Ciencias Médicas Unidad de Investigación Científica Home page: CITI Programa de Educación en Ética de la Investigación https://www.citiprogram.org El Programa CITI ofrece: Curso Básico y de Repaso para la Protección de los Sujetos Humanos de Investigación o Enfoque en Investigación Biomédica o Enfoque en Investigaciones Sociales y de Conducta Curso en Buenas Practicas Clínicas y la Conferencia Internacional de Armonización ( ICH) o 15 módulos para investigadores que conducen estudios con nuevas drogas y dispositivos de investigación Curso sobre Privacidad y Seguridad en el Manejo de Información de la Salud ( HIPS) o Los Cursos pueden ser adaptados para : Clínicos Investigadores Clínicos Estudiantes Encargados de conseguir donaciones Comercializadores Curso en Cuidado y Bienestar de Animales de Laboratorio Laboratory Curso en Conducta Responsable de la Investigación (RCR) Nuevos Cursantes de las Organizaciones Participantes de CITI. Si su organización participa en el Programa CITI y esta es su primera vez en los Cursos de CITI, usted debe registrarse. Este es un proceso sencillo. 1

2 En las pantallas siguientes, usted deberá: 1. Elegir su participación institucional. 2. Elegir Nombre de Usuario y clave. 3. Brindar la información de contacto requerida por su institución. 4. Usted tendrá la oportunidad de registrase con otra Institución ( por ejemplo, un hospital local o la institución de un colaborador). Esta es una opción accesible ya que no se le pedirá completar los mismos módulos requeridos por ambas instituciones mas de una vez. 5. Responder 1 o mas preguntas acerca de su rol o su su enfoque como investigador, de manera que el software le presente el curriculum mas apropiado. 6. Luego que seleccione la currícula, el software lo llevara al "Menu Principal para Cursantes" 7. Entonces usted podra "Presionar en este enlace (Grade book) para entrar al curso. 8. Los módulos aparecerán en pantalla. Reingresando al curso CITI. ISi usted ha obtenido previamente un Nombre de Usuario y una Clave, ingrese en para retomar su curriculum en el Libro de Grados (Grade Book). Si usted tiene un Nombre de Usuario y una Clave obtenida en una version previa (Antes de Mayo 2004), esta combinación de Nombre de Usario/ Clave no esta mas en nuestra base de datos. Por lo tanto es necesario que se Registre Nuevamente en el Curso, usando el enlace "Regístrese Aqui" en la Pagina de Inicio. El Acceso Publico al Curso sobre Conducta Responsable en la Investigacion (RCR) El acceso publico al curso sobre Conducta Responsable en la Investigación esta designado para proveer a los cursantes que no estan afiliados con una Institución Participante de CITI, una oportunidad para completar un tutorial básico. El acceso publico asimismo, puede ser usado por quienes toman decisiones en la institucion para ofrecer una " Demostración" sobre el curso en forma previa a ser brindarlo a sus miembros, empleados o estudiantes. El Curso en Conducta Responsable de la Investigacion es parcialmente apoyado por la Oficina de Integridad en la Investigación ( ORI), parte del Departamento de Salud de los Estados Unidos de América. 2

3 El acceso publico al curso esta disponible en versiones para investigadores y estudiantes con especial interés en : Ciencias Biomédicas Ciencias Sociales y de Conducta Ciencias Físicas Humanidades Cursos totalmente adaptables están disponibles a las organizaciones participantes de CITI. Si usted quiere establecer un curso adaptado a las necesidades de su Universidad, Organización, Departamento o Clase, por favor contáctese con CITI en el (001) El Curso sobre Cuidado y Bienestar de Animales de Laboratorio de CITI. El curso de CITI sobre Cuidado y Bienestar de Animales de Laboratorio esta ahora disponible para las instituciones suscriptoras del programa. El curso es una version actualizada de lo establecido por los Hospitales de Veteranos de los Estados Unidos ( VA). Ingrese al curso en Este curso cumple con los requisitos Federales de los Estados Unidos para en entrenamiento básico en el cuidado humano de los animales de laboratorio en investigación y entrenamiento. Una "Demostracion" esta disponible en "Registrandose para un Curso" ( Registering for a Course) en la pagina principal. Cuando se le pregunte sobre su afiliacion institucional, elija "CITI Lab Animal Welfare Demonstration Course". Provea la informacion de contacto requerida. Entonces inscribase en los cursos que gustaria de revisar. Si su organización desea subscribirse al Curso CITI sobre Cuidado y Bienestar de Animales de Laboratorio, por favor llame a CITI al (001) o envienos un correo a Para mas información vea las Preguntas Frecuentes ( FAQ and Announcements) disponibles en la pagina de inicio de CITI. El Curso sobre Privacidad y Seguridad en la Informacion sobre Salud. (HIPS) Una muestra del curso esta disponible aqui. Los cursos adaptables estan disponibles para las instituciones subscriptas. Los modulos que pueden ser adaptables de acuerdo a las necesidades son: 3

4 Reglas de Privacidad: Introducción a los Requisitos Federales y Estatales en los Estados Unidos * Reglas de Privacidad: Clínicos* Reglas de Privacidad: Investigadores Clínicos* Reglas de Privacidad: Estudiantes e Instructores* Reglas de Privacidad: Personas que colectan fondos * Reglas de Privacidad: Comercializadores* Reglas de Privacidad: Aspectos Básicos para Sentirse Seguro, Parte 1* Reglas de Privacidad: Aspectos Básicos para Sentirse Seguro, Parte 2* Reglas de Privacidad: Protegiendo su Computador* Reglas de Privacidad: Eligiendo y Protegiendo Claves ** Reglas de Privacidad: Protegiendo sus Elementos Portatiles.* Reglas de Privacidad: Protegiendo su Identidad.* Reglas de Privacidad: Cuidados en Correos Electrónicos y Mensajeria Electrónica, Parte 1*. Reglas de Privacidad :Cuidados en Correos Electrónicos y Mensajeria Electrónica, Parte 2* * Reglas de Privacidad: Cuidados al Navegar Internet. Reglas de Privacidad: Introduccion a los Requisitos Federales de los Estados Unidos* Reglas de Privacidad: Temas para Trabajadores a Distancia.* Completando el Curso de Seguridad en la Informacion. La Plataforma Internacional de Entrenamiento de CITI en es un sitio de acceso publico que provee infromacion fundamental para investigadores, equipos de investigación, y miembros de comités de ética de investigación involucrados en proyectos internacionales. Este programa ahora incluye dos lineas para cursantes. La linea 1 enfoca al investigador internacional ( Modulos Internacionales) en tanto que la linea 2 esta conjcebida para investigadores que no pertenecen a los Estados Unidos, pero que trabajan en proyectos financiados por el Gobierno Federal. ( Modulos Federales de los Estados Unidos). LINEA 1. Los Módulos Internacionales son una nueva oferta del Programa CITI. Esta línea fue desarrollada por el Dr. Henry Silverman y sus equipo del Fogarty Internacional Center en Egipto. Estos modulos proporcionan una vision general de los temas éticos relacionados con la protección de sujetos humanos internacionalmente. Esta línea esta siendo traducida del Ingles a otros idiomas. LINEA 2. Los Módulos aplicables a los Requisitos Federales de los Estados Unidos proporcionan mas detalles sobre los requisitos necesarios para desarrollar 4

5 investigaciones con fondos federales de los Estados Unidos. Los modulos 1 al 3 han sido traducidos en Chino Simple, Frances, Portugués y Español. Los Modulos 4 y 5 estan disponibles en Ingles con el contenido parcialmente traducido. Los temas para ambas lineas son: 1. Historia y Ética. 2. Proceso de Revision de la Investigación. 3. Consentimiento Informado. 4. Estudios Internacionales. (Recursos e Información especifica por pais) 5. Curso de Documentación.(Documentos de Guías Éticas y enlaces a Información) Aunque usted necesitara registrarse para obtener un nombre de usuario y clave, para este curso, el programa esta disponible sin cargo. Este sitio es provisto como un servicio a la comunidad de investigacion y es apoyado por CITI, el Fred Hutchinson Cancer Research Center y la Universidad de Miami. Dado que esta experiencia es relativamente nueva, sus preguntas, comentarios o sugerencias son bienvenidos. Por favor envielas a Karen Hansen en Gracias. Uso simultaneo del Programa A veces, el programa CITI esta sumamente cargado por la cantidad de usuarios simultaneos. Durante los meses que preceden al cierre de las presentación de grants al Servicio Nacional de Salud ( NIH) Al comienzo del Septiembre y Enero. El Programa CITI tiene un pico en su uso despues de las 10 AM, hora del este de los Estados Unidos, y registra otros entre las 11 AM y las 4 PM, tendiendo a decrecer marcadamente despues de las 11 PM, siempre hora del este de los Estados Unidos. Durante los fines de semana el uso es generalmente < 50% que durante la semana. Normalmente, existe una limitacion a 1500 usuarios concurrentes para permitir a cada uno, la oportunidad de usar el curso contando con una rápida respuesta del sitio. Gracias 5

6 Administracion del Programa CITI Short Description of CITI Human Subjects and GCP Modules Last Updated: Aug 17, :34PM EDT Human Subjects Research (HSR) Modules Biomedical Research Basic Course Belmont and CITI Course Introduction This module provides a link to the Belmont Report. This module also provides some additional information regarding the CITI web site and the availability of the Belmont Report in English, Chinese, Spanish, and French. History and Ethical Principles This module discusses why ethics are necessary when conducting research involving human subjects and provides an overview of the historical events that influenced the development of the current regulatory requirements. A review of the Belmont Principles is also provided. The module concludes with a discussion of the contemporary ethical standards that guide research today. Basic Institutional Review Board (IRB) Regulations and Review Process IRBs are a standard within the area of human subjects research. This module provides basic information about the human subject protection regulations and IRBs, including the role, authority, and composition of the IRB. The information presented is based on the Common Rule as codified by the U.S. Department of Health and Human Services (DHHS) at 45 CFR 46. The different types of IRB review processes are discussed, providing the learner with an overview of the essential issues associated with exempt, expedited, and full (convened) IRB reviews. The module concludes with a discussion of the other regulations and requirements (such as the U.S. Food and Drug Administration [FDA] and the International Conference on Harminosation [ICH]) and regulatory groups (for example, the National Institutes of Health [NIH] and the Department of Education [DOE]) that require compliance based on certain types of research. Informed Consent 6

7 A fundamental tenet of human subjects research, the process and documentation of informed consent are important concepts for researchers to understand. To that end, this module provides the learner with the framework for informed consent found within the Common Rule. Some of the special challenges associated with informed consent are also discussed, including informed consent as it relates to vulnerable populations. The module concludes with a review of the requirements for waiver of informed consent as well as the differences between FDA and DHHS regulations. Social and Behavioral Research (SBR) for Biomedical Researchers Because biomedical researchers employ a variety of SBR techniques within the framework of biomedical research, it is important to understand the nature, risks, and benefits associated with these techniques. This module discusses the types of studies that utilize SBR techniques, along with the kind of data collected. A review of some of the risks and benefits that are unique to SBR completes the course. Records-Based Research Researchers may make important advances in the fields of education, medicine, psychology and public policy by using previously collected information that does not involve prospective interaction with human subjects. Records-based research has its own risks, and researchers who propose to conduct such research must have an understanding of those risks and how to minimize them. As a compliment to that review, this module also provides learners with an overview of the types of review processes required for records-based research. This overview includes the questions that must be addressed in order to make the appropriate determinations with respect to review. Genetic Research in Human Populations Although continued advances in genetic research present exciting opportunities in biomedicine, they also present some of the most difficult challenges with respect to the protection of human subjects. This module begins with an introduction to the types and complexity of genetic research. The learner is then provided with a review of ethical, legal, and regulatory issues associated with genetic research. A discussion of the hot topic of stored biological samples concludes the module. Research with Protected Populations Vulnerable Subjects: An Overview The concept of vulnerable subjects is important to research ethics and regulatory compliance. The foundation for this module is provided by an overview of DHHS and FDA regulations as well as ICH guidelines. This module provides learners with an overview of the issues related to diminished autonomy, and the need for additional protections. An overview of different classes of vulnerable subjects concludes the module. Vulnerable Subjects Research with Prisoners This module describes the special requirements for conducting research with prisoners. The learner is provided with a review of why incarcerated individuals need special protection, as well as the regulatory definition of what constitutes a prisoner. The module also includes a discussion of each of the permitted categories for research involving prisoners and the required IRB considerations and determinations. Module concludes with the topic of what happens if an enrolled subject becomes a prisoner. 7

8 Vulnerable Subjects Research with Children This module describes the major historical events that influenced how research with children can be conducted. It describes problems with this type of research that may violate ethical standards, the assent and informed consent requirements, and the current efforts by the FDA to ensure the inclusion of children in studies on the safety and efficacy of new drugs. An overview of the categories of research involving children is provided, including examples. Vulnerable Subjects Research Involving Pregnant Women, Fetuses, and Neonates This module describes the historical exclusion of women of child-bearing potential and the special requirements for conducting research involving pregnant women and fetuses. It includes a discussion of each of the permitted categories for research involving the pregnant women, fetuses, and neonates and IRB review requirements and determinations. Informed consent requirements associated with the different categories of research permitted with fetuses are also discussed. Avoiding Group Harms: U. S. Research Perspectives Avoiding Group Harms: International Research Perspectives These modules describe some distinct groups or communities of people who are vulnerable. In addition, learners are provided examples of research that have caused group harms. The module concludes with strategies that researchers can take to reduce the risk of group harms. The material is customized for International Research Perspectives and U.S. Research Perspectives. Institutions can choose to assign either of the versions depending upon the institution s research activities. FDA-Regulated Research This module addresses FDA-regulated clinical research and the responsibilities of investigators, IRBs, and sponsors when an FDA-regulated product is utilized in a study. In particular, the module includes information on when an Investigational New Drug (IND) application is necessary and the requirements of the FDA Form A sub-module discusses the International Conference on Harmonisation (ICH) guidelines. Stem Cell Research Oversight (Part I) This module is the first of a series of modules on human stem cells and introduces the learner to the nature and characteristics both adult and embryonic stem cells. Learners are provided a review of the requirements of the federal regulations associated with stem cell research and the role of both state and local requirements. Stem Cell Research Oversight (Part II) This module builds on the content presented in Part I and providesa framework for institutional review of stem cell research, national guidelines as well as current federal law and policy. This module provides an overview of the National Academy of Sciences (NAS), International Society for Stem Cell Research (ISSCR), and the NIH guidelines related to human stem cell research and research involving human subjects. Consideration is given to DHHS and FDA regulatory requirements, Stem Cell Research Oversight (SCRO) committee composition and responsibilities, categories of research, and a comprehensive definition of provenance as it applies to human stem cell research. A detailed overview of the recommendations of the NAS, 8

9 ISSCR and NIH Guidelines as well as information related to the procurement, banking, and use of human stem cell lines are provided via the hyperlinks that follow the module. Unanticipated Problems and Reporting Requirements in Biomedical Research The FDA and the DHHS human subject protection regulations require institutions to have policies and procedures to ensure prompt reporting of unanticipated problems (UPs) involving risk to subjects or others to the IRB, regulatory agencies, and appropriate institutional officials. In addition, FDA regulations require investigators to promptly report to the IRB all UPs involving risk to subjects or others and unanticipated adverse device effects. The purpose of this module is to provide guidance to investigators on complying with DHHS and FDA reporting requirements by providing an overview of UPs, unanticipated adverse device effects, and the relationship between adverse events and UPs involving risk to subjects or others. As a part of the discussion, the module includes a discussion on how to detect UPs and how to report them. Social and Behavioral Research (SBR) Basic Course History and Ethical Principles SBR This module discusses the evolution of the ethical principles in the United States that guide research design as well as the development of the federal regulations that govern the conduct of research relevant to researchers in the social and behavioral sciences. It reviews why ethics are necessary when conducting research involving human subjects including major historical events that have influenced how human subjects research is conducted. It describes problems with past studies that have violated ethical standards or have raised ethical concerns that have contributed to the national dialog related to the protection of human subjects. The Belmont Principles are discussed as the basis for the ethical standards for research that guide us today. Defining Research with Human Subjects SBR This module discusses an interpretation of definitions of the terms human subject and research with an emphasis on the interpretation for human subjects research in the social and behavioral sciences. Also included is a discussion as to the differences between private and public information and behavior, a critical aspect of many types of social and behavioral research. The Regulations and The Social and Behavioral Sciences SBR This module provides an overview of the federal regulations and their basic provisions. A close reading of the regulations includes research methods and topics of inquiry relevant for researchers in the social and behavioral sciences and the humanities. Methods include surveys, interviews, focus groups, oral history, participant observation, observations of public behavior, and the analysis of existing data. This module provides specific examples of the ways in which the federal regulations are particularly pertinent to social and behavioral science researchers and the methodologies noted. In addition, regulatory information pertinent to social and behavioral researchers is covered including the criteria for expedited and full board review and the authority of the IRB. 9

10 Assessing Risks in Social and Behavioral Sciences - SBR This module discusses the challenges in identifying and evaluating risks associated with participation in social and behavioral sciences research. Unlike biomedical clinical trials, risks associated with social and behavioral science research are often elusive and less predictable. Topics include assessing risks, balancing risks and potential benefits, minimizing and managing risks, certificates of confidentiality, and ways to address risks in the informed consent document and process. Informed Consent SBR This module discusses the process and documentation of informed consent, including informed consent guidelines as well as the required and additional elements of informed consent as described by the regulations. There is also a discussion of the circumstances under which an IRB may waive the requirements for informed consent with examples of how this commonly is applied in social and behavioral sciences research. The module also includes information related to recruitment, consent comprehension, timing of consent, and exculpatory language, topics that are important to the overall concept of informed consent. Privacy and Confidentiality SBR This module defines privacy and confidentiality. It includes a discussion on protecting privacy in research and guidelines for designing confidentiality procedures. Topics include private versus public behavior, controlling access to private information, privacy and exempt research, privacy and research methods, confidentiality, privacy and reporting laws, and certificates of confidentiality. The discussion focuses on how these concepts apply to social and behavioral science research. Research with Prisoners as Subjects SBR This module describes the requirements for conducting research with prisoners. Included in the discussion is a review of the regulatory definition of a prisoner, the permitted categories of research involving prisoners and IRB review considerations. Importantly, the module contains a discussion on essential elements related to designing prisoner research, including consent issues and the assessment of risk. The module concludes with information related to accessing prisoner populations. Research with Children SBR This module describes regulations that apply to research with children. It defines children and discusses examples of research that meet the criteria of exempt research and expedited review and issues involved in obtaining and documenting parental permission and child assent.. Included in the discussion is a review of the criteria for waiver of parental permission and/or child assent. Research in Public Elementary and Secondary Schools SBR This module provides an overview of the types of public school research, and the regulations that apply to research in these settings. Individual sections discuss the Family Educational Rights and Privacy Act (FERPA), the Protection of Pupil Rights Amendment (PPRA), and Subpart D at 45 CFR 46: Additional Safeguards for Children. Examples of activities that may qualify for exemption are discussed. The module concludes with a discussion of parental permission and child assent issues, as well as research-related harms to children and requirements for reporting 10

11 observed child abuse and neglect. International Research SBR Social and behavioral scientists conduct research around the globe. This module includes a discussion of applicable regulations and guidelines and the importance of the local context. Because international research may also include collaborating institutions, the module provides information related to engagement in research. Additional topics include determining where research should be reviewed, exempt research, and informed consent considerations. Internet Research SBR The Internet, with an estimated 500 million users worldwide, has much to offer researchers, both as a research tool and as the object of study. This module presents the problems associated with obtaining consent on-line and explains why privacy and confidentiality may be of particular concern for Internet research. In addition, several problems with assessing risks of harm associated are included as it may often be difficult for investigators to assess these risks if they do not have previous experience with Internet-based research. Unanticipated Problems and Reporting Requirements in Social and Behavioral Research This module provides learners with an overview of unanticipated problems, including the OHRP criteria that are to be used to determine if an event constitutes an unanticipated problem. The module continues with a discussion on reporting requirements and the various types of actions an IRB may take in response to an unanticipated problem. Additional Modules of Interest Note that these modules may be added to either the HSR-Biomedical or HSR-SBR courses by institutions. Students in Research This module is designed as a "one-stop shop" for students who may be involved in a human subjects research as an investigator and/or a subject. Degree requirements in undergraduate, masters, or doctoral degree programs often require students to conduct or assist in research projects that include human subjects. In addition, students may be asked or be "required" to participate as subjects in research projects. A review of the history and principles of ethics for research involving human subjects, including a definition of research and categories of review; students as researchers; the role and operations of IRBs; and the issues related to students as subjects are provided, as well as a resource section. Human Subjects Research at the VA This module describes the requirements for protection of research subjects at VA facilities. Many academic centers are affiliated with a VA clinic or hospital. Researchers proposing to recruit research subjects from VA facilities must follow the VA requirements. This module also provides a review of what makes the VA patient population unique and includes an overview of legally authorized representatives for VA research.. 11

12 HIPAA and Human Subjects Research This module discusses the requirements of the Health Insurance Portability and Accountability Act (HIPAA) and how they supplement the DHHS and FDA requirements. Situations where full HIPAA privacy protections are required, and those that can qualify for waivers, alterations or exemptions with more limited requirements are discussed. The module also includes a discussion of the responsibilities of investigators and institutions for meeting HIPAA privacy requirements, and for appropriate data security protections that are necessary to protect privacy. Vulnerable Subjects Research with Workers/Employees This module describes why workers may be a vulnerable population when they participate in research and the potential risks and benefits associated with research involving workers/employees. The module also discusses protections that need to be afforded to workers/employees. It proposes that while workers may serve as study subjects for political as well as scientific reasons, adequacy of the science and adherence to the Common Rule is paramount. Conflicts of Interest in Research Involving Human Subjects This module describes conflicts of interest, which are frequently debated and defined by varying regulatory requirements. The module includes a general discussion of conflicts of interest with an emphasis on financial conflicts of interest, and the ethical concerns that arise in human subject research. This is followed by a review of the current reporting and disclosure requirements for investigators, including the 2011 PHS amendment and the FDA regulations. The role of IRBs and the primary strategies for eliminating, reducing, and managing conflicts of interest completes the module. The IRB Member Module What Every New IRB Member Needs to Know This module is designed as an overview and resource for individuals joining an IRB. It includes discussions on time commitment, liability, the role of the IRB chair, and the levels of review. An overview of IRB tools, including the content of new submissions as well as what is often seen during continue review provides a foundation for new IRB members and is complimented by a discussion on how IRB member can review protocols. The module concludes with information related to the IRB meeting, including the importance of quorum, the types of IRB decisions, and the review of minutes. The module is designed for new scientific and non-scientific members, but may also be useful for any IRB member who continues to serve on an IRB. International Studies This module provides information for U.S. researchers and/or collaborating international research investigators who receive funding from the U.S. federal government sources and who plan to conduct human subject research outside the U.S. The module is focused on international research ethics, US government and international guidelines. It includes a list of ethical review hyperlinks for countries and regions of the world. It is intended to help researchers and their staff members identify ethical requirements of their global research partners. I Have Agreed to be an IRB Community Member. Now What? This module is designed for new IRB community members, but may be useful to anyone involved with human subjects research. It provides the basic information and tools, including an overview of definitions and the regulations, and an approach in order for a community member to 12

13 become a well-informed IRB member. The module offers an overview of various aspects of the IRB review processes as it relates to specific kinds of protocols. The IRB Administrator s Responsibilities This module is intended for IRB administrators and directors; however, all individuals within an IRB office might benefit from the information presented in the module. An overview of the basic policies and procedures that institutions should have with regard to the human subjects protection program, including the IRB, provides the foundation for the IRB administrator/director s responsibilities. Are you Thinking About Being In a Research Study? This module is for individuals who are interested in volunteering to be a research subject. This module is also be beneficial as an adjunct to the informed consent process for those who have already been recruited to participate in a research project. The module provides the definition of what research is and an overview of critical components associated with human subjects research and is presented in a user-friendly question and answer format. Items covered include information on the informed consent process and what to expect after agreeing to participate in research. This module can be used in conjunction with institution specific materials. Hot Topics This optional module is designed to provide learners with current information on recent developments in the IRB Universe. It is updated annually with previous content archived and accessible to learners. Cultural Competence in Research This module provides learners with an overview of the essentials of practicing cultural competence in research. This module describes the importance of understanding the subject demographics, historical contexts, communication styles, customs, values, and beliefs of research study populations involved in research. The module continues with a discussion of how institutional review boards (IRBs) and researchers can operate to support this work. GCP Course (US FDA Focus) This course is intended for research personnel involved in conducting drug, device, or biologic studies and who would benefit from a U.S. FDA focused curriculum. For the GCP Course, it is strongly recommended that all modules be included and that they be completed in the order listed in the GCP Introduction. GCP Introduction This module provides an overview of the GCP course along with links to the Belmont Report. Overview of New Drug Development 13

14 This module describes the role of industry sponsors in the conduct of clinical trials under an Investigational New Drug (IND) application in the U.S. according to FDA regulations. It provides an overview of definitions, procedures, and timelines associated with the development of a new drug. ICH Overview The purpose of this module is to provide a basic understanding of the role of the International Conference on Harmonisation (ICH) Guidelines and the impact on conducting clinical research according to Good Clinical Practice (GCP). The purpose of ICH and the basic requirements for compliance with ICH are described, including an overview of the ICH E6 GCP guidelines. The module concludes with a discussion on when the ICH GCP guidelines apply and an introduction on how these differ from the FDA regulations. ICH Comparison Between ICH GCP E6 and U.S. FDA Regulations This module expands on the introduction presented in the ICH Overview module. The major differences between ICH guidelines and U.S. FDA regulations are presented, including critical areas such as confidentiality of medical records, signature of person conducting the consent discussion, and impartial witnesses for illiterate subjects. The module also covers the differences between ICH GCP E6 and FDA in terms of elements of consent. Conducting Investigator-Initiated Studies According to FDA Regulations and Good Clinical Practices This module discusses topics important to researchers who are also the sponsors of studies and thus are conducting investigator-initiated studies. Topics discussed include how to determine whether an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) is required, the role of the sponsor-investigator, documentation required for INDs and IDEs, and reports that must be submitted to the FDA for active INDs/IDEs. Investigator Obligations in FDA-Regulated Clinical Research This module describes the commitments and obligations assumed by investigators when they conduct clinical investigations sponsored by pharmaceutical companies under IND requirements, including the requirements of the FDA Form 1572, Statement of Investigator. Required study records and reporting requirements continue the discussion. An overview of the investigator's relationship with the sponsor organization as well as the investigator's commitment to the subjects, the Institutional Review Board/Ethics Committee (IRB/IEC), and the U.S. Food and Drug Administration (FDA) are also included. Managing Investigational Agents According to GCP Requirements This module focuses on specific requirements associated with the management of investigational products by investigators. This includes requirements for shipping and storage of investigational agents, as well as recording the receipt, use, and final disposition of investigational agents. The module also reviews what constitutes investigational products and the management requirements for their use by study subjects. Conducting Clinical Trials of Medical Devices 14

15 This module reviews the responsibilities of investigators conducting clinical research involving medical devices. It includes a discussion of the difference between significant risk and nonsignificant risk devices. The characteristics and marketing requirements for Class I, II, and III devices are reviewed. The module concludes with a review of investigator and IRB responsibilities associated with clinical trials of medical devices and a discussion of the different options associated with early access to investigational devices in advance of FDA approval. Informed Consent This module discusses informed consent guidelines, the required and optional elements of informed consent and the process for obtaining informed consent. There is also a discussion of the differences between FDA and DHHS regulations. Some of the challenges associated with informed consent and the concept of vulnerable subjects are also reviewed. Detection and Evaluation of Adverse Events This module reviews the definition of adverse events (AEs) and related clinical trial terminology. It describes the process for identifying AEs in clinical research, the issues to consider in assessing the severity and causality of AEs with examples to illustrate the evaluation process. The module also contains a discussion on determining severity and causality. Reporting of AEs to the IRB completes the module. Reporting Serious Adverse Events This module discusses the criteria for reporting of serious adverse events (SAEs) to regulatory agencies, sponsors, etc. The discussion includes definitions for "serious" and "unexpected" adverse events and reviews the requirements for reporting of SAEs within time frames required by FDA and ICH. The module provides categories of relatedness to the investigational agent and how they affect reporting. Monitoring of Clinical Trials by Industry Sponsors This module describes the obligation of industry research sponsors to monitor the progress of clinical trials under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application in the U.S. The types of site visits conducted by industry sponsors are described along with the basic requirements for each type of site visit. The module describes the role of the investigative site during interactions with industry sponsors as well as the requirements for record-keeping in studies regulated by the U.S. FDA. Audits and Inspections in Clinical Trials This module provides a basic understanding of monitoring, audits, and inspections of clinical trials conducted according to GCP standards. It describes the different entities that can inspect or audit a clinical trial and the investigator, the factors that can determine whether an investigator will be audited, what the auditors and inspectors are looking for, and the results and consequences that can occur as a of FDA inspection findings. Some FDA regulated research may also involve federal funding, thereby requiring oversight by Office for Human Research Protections (OHRP). As a result, the module includes a information on OHRP compliance site visits and outcomes. The purpose of the FDA Bioresearch Monitoring Program is discussed. 15

16 GCP Course for Clinical Trials Involving Investigational Medical Devices This course is intended for research personnel involved in conducting device studies. It should be noted, that where appropriate reference to FDA regulations and guidance is also included. For the GCP Course, it is strongly recommended that all modules be included and that they be completed in the order listed in the GCP Introduction. GCP Introduction This module provides an overview of the GCP course along with links to the Belmont Report. Conducting Investigator-Initiated Studies According to FDA Regulations and Good Clinical Practices This module discusses topics relevant to researchers who are also the sponsors of studies, i.e., investigator-initiated device studies. Topics discussed include significant risk (SR) and nonsignificant risk (NSR) device studies, sponsor-investigator Investigational Device Exemptions (IDEs), and reporting requirements. Investigator Obligations in FDA-Regulated Clinical Research Investigators assume responsibilities when participating in clinical investigations sponsored by device companies under IDE requirements. This module describes the commitments and obligations assumed by investigators. Required study records and reporting requirements continue the discussion. An overview of the investigator's relationship with the sponsor organization as well as the investigator's commitment to the subjects, the Institutional Review Board/Ethics Committee (IRB/IEC), and the U.S. FDA is also included. Managing Investigational Devices According to GCP Requirements This module focuses on specific requirements associated with the management of investigational products by principal investigators, with a specific focus on GCP standards. The module includes a discussion of the regulation of investigational devices, including sponsor requirements for selecting investigators, investigator control of devices, packaging and shipping, and storage of devices.. Conducting Clinical Trials of Medical Devices This module reviews the responsibilities of investigators conducting clinical research involving medical devices. It includes a discussion of the difference between significant risk and nonsignificant risk devices. The characteristics and marketing requirements for Class I, II, and III devices are reviewed. The module concludes with a review of investigator and IRB responsibilities associated with clinical trials of medical devices and a discussion of the different options associated with early access to investigational devices in advance of FDA approval. Informed Consent in Clinical Studies of Devices This module discusses the informed consent guidelines, the required and optional elements of informed consent and the process for obtaining informed consent. There is also a discussion of 16

17 the differences between FDA and DHHS regulations. Challenges associated with informed consent and the concept of vulnerable subjects are also covered. Monitoring of Clinical Trials of Devices by Industry Sponsors This module describes the obligation of industry research sponsors to monitor the progress of clinical trials under an Investigational Device Exemption (IDE) in the U.S. The types of site visits conducted by industry sponsors are described along with the basic requirements for each type of site visit. The role of the investigative site during interactions with industry sponsors as well as the required documentation and a review of record keeping in studies regulated by the U.S. FDA are also covered. Audits and Inspections in Clinical Trials of Devices This module provides a basic understanding of monitoring, audits, and inspections of clinical trials conducted according to standards for good clinical practice (GCP). It describes the different entities that can inspect or audit a clinical trial and investigator, the factors that can determine whether an investigator will be audited, what the auditors and inspectors are looking for, and the results and consequences that can stem from FDA inspection findings. Because some FDA regulated research may also involve federal funds there may also be Office for Human Research Protections (OHRP) oversight. As a result, the module includes an overview of OHRP compliance site visits and outcomes. The purpose of the FDA Bioresearch Monitoring Program is discussed. Reporting Requirements for Device Studies The use of investigational devices can pose significant risks to subjects, and the U.S. Food and Drug Administration (FDA) requires reporting of certain events to ensure that all entities are adequately informed when new risk appear. This module explains the reporting requirements of 21 CFR 812, the FDA regulations for the conduct of investigational device studies. GCP Course for Trials With Investigational Drugs (International/ ICH focus) This course is intended for research personnel involved in conducting drug and biologic studies and who would benefit from a more internationally focused curriculum. It should be noted, however, that when appropriate reference to FDA regulations and guidance are also included. For the GCP Course, it is strongly recommended that all modules be included and that they be completed in the order listed in the GCP Introduction. GCP Introduction This module provides an overview of the GCP course along with links to the Belmont Report. Conducting Investigator - Initiated Studies According to FDA Regulations and GCP Medical research is important and investigators strive to find novel therapies, new drugs, and modifications or new uses for existing drugs. This module introduces the requirements that must 17

18 be met to conduct investigator-initiated trials of investigational drugs. The module provides an overview of when an Investigational New Drug (IND) application must be filed the information that must be provided, and the requirements for monitoring of clinical trials. Given ICH E6 as a standard for the elements of clinical research including design, conduct, performance, monitoring, and auditing, this module provides a discussion as to the purpose of monitoring and summarizes its components. Investigator Obligations in FDA-Regulated Clinical Research When investigators participate in an industry-sponsored clinical investigation,, they assume certain professional and legal obligations. Investigators, therefore, must understand the study and regulatory requirements to ensure the successful outcome of a clinical investigation. The module provides an overview of investigator commitment and obligations and summarizes the investigator s relationship with the industry-sponsor. Particular attention is focused on two aspects of the sponsor s site assessments as circumscribed by ICH guidelines adequate resources and medical care of trial subjects. Reporting and record-retention are also included, with applicable references to both FDA and ICH requirements. Managing Investigational Agents According to GCP Requirements GCP standards require specific management of investigational products by principal investigators. Definitions and information related to the requirements for the use of investigational products, as defined by FDA and ICH, are presented as a basis for this module. ICH requirements associated with investigator control continues the discussion. The module concludes with sections on shipping, storage, dispensing, and final disposition of investigational agents. Informed Consent in Clinical Trials of Drugs This module discusses the informed consent guidelines (as reflected in both FDA regulation and ICH guidelines), the required and optional elements of informed consent. The module also includes a discussion of the documentation of consent with specific discussion on the role of legally authorized representatives. Some of the challenges associated with informed consent and the concept of vulnerable subjects are also covered, including issues related to subjects who cannot consent and the exceptions to the informed consent requirements. Monitoring of Clinical Trials of Drugs by Industry Sponsors U.S. Federal regulations and the ICH guidelines require that sponsors of clinical research monitor the studies of investigational drugs to ensure that they comply with standards for the protection of human research subjects. This module describes the obligation of industry sponsors to monitor the progress of clinical trials under an Investigational New Drug (IND) application as well as the requirements for site record-keeping in studies that are regulated by the FDA and in adherence to ICH E-6. Audits and Inspections in Clinical Trials This module provides basic information on monitoring, audits, and inspections of clinical trials conducted according to standards for good clinical practice (GCP). It describes the different entities that can inspect or audit a clinical trial and the investigator, the factors that can determine whether an investigator will be audited, what the auditors and inspectors are looking for, and the 18

19 results and consequences that can occur as a result of FDA inspection findings. Regulatory documents reviewed during inspections are presented and referenced to FDA and ICH GCP requirements. Overview of New Drug Development This module describes the role of industry sponsors in the conduct of clinical trials under an Investigational New Drug (IND) application in the U.S. according to FDA regulations. It provides an overview of definitions, procedures, and timelines involved in the development of a new drug. ICH Overview The purpose of this module is to provide an overview of the role of the International Conference on Harmonisation (ICH) Guidelines and its impact on conducting human clinical research. The purpose of and the basic requirements for compliance with ICH are described, including an overview of the ICH E6 GCP guidelines. The module concludes with a discussion on when the ICH GCP guidelines apply and an introduction on how these differ from the FDA regulations. ICH Comparison Between ICH GCP E6 and U.S. FDA Regulations This module expands on the introduction presented in the ICH Overview module. The major differences between ICH guidelines and U.S. FDA regulations are presented, including discussion on specific areas such as confidentiality of medical records, signature of person conducting the consent discussion, and impartial witnesses for illiterate subjects and the elements of informed consent. Detection and Evaluation of Adverse Events This module reviews the definition of adverse events (AEs) and related clinical trial terminology in accordance with ICH guidelines. It describes the process for identifying AEs in clinical research and identifies the factors to consider in assessing the severity and causality of AEs. Examples are provided to illustrate the evaluation process. The module also includes discussion on determining AE severity and causality, and reporting of AEs to IRBs. Reporting Serious Adverse Events in Investigations of Drugs and Biologics This module discusses the criteria for reporting serious adverse events (SAEs) to regulatory agencies, sponsors, etc. The discussion is framed by FDA regulations and ICH guidelines, includes definitions for "serious" and "unexpected" adverse events and the time frames for reporting of SAEs. The module provides categories of relatedness to the investigational agent and how they affect reporting. 19

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