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  • Institutional Review Board (IRB) Overview

    Contains 5 Component(s), Includes Credits

    This presentation will provide a basic overview of the regulatory requirements and responsibilities for an Institutional Review Board (IRB) review for human subjects protection. Usual business practices for most IRBs will be discussed including the required members of an IRB, required documentation that must be submitted to an IRB, and the types of IRB reviews.

    This presentation will provide a basic overview of the regulatory requirements and responsibilities for an Institutional Review Board (IRB) review for human subjects protection. Usual business practices for most IRBs will be discussed including the required members of an IRB, required documentation that must be submitted to an IRB, and the types of IRB reviews.

    Objectives:

    1. Discuss the purpose of the IRB
    2. Discuss who constitutes the IRB
    3. Discuss different types of IRBs
    4. Discuss the submission requirements for IRB approval

    Mtonya Hunter, MBA, CCRP

    Team Lead

    Mtonya Hunter has 10+ years of experience working in clinical research and currently serves as a Team Lead in Regulatory for the Translational Research Institute at the University of Arkansas for Medical Sciences. She earned her Master of Business Administration from the University of Phoenix and Bachelor of Technical Writing and Associates of Law Enforcement from the University of Arkansas at Little Rock. She has been a Certified Clinical Research Professional since 2017. She was a poster presenter at the 2019 Annual Conference and currently serves as a speaker for the Arkansas SOCRA Chapter.

  • A Primer on Clinical Research

    Contains 5 Component(s), Includes Credits Recorded On: 04/01/2020

    This presentation will introduce different practices and principles for how new medicals products are identified as safe and effective, and ultimately introduced into the marketplace. How clinical research came to be and how professionals deal with proving that products are safe and effective will be discussed. Lastly, the speaker will discuss the evolving research approaches used today.

    This presentation will introduce different practices and principles for how new medicals products are identified as safe and effective, and ultimately introduced into the marketplace. How clinical research came to be and how professionals deal with proving that products are safe and effective will be discussed. Lastly, the speaker will discuss the evolving research approaches used today.  

    LEARNING OBJECTIVES

    Discuss how new medical products might help to identify and mitigate the impact of COVID-19, and other viruses, on our health

    Discuss different practices and principles for how products are identified as safe and effective for humans

    Discuss how new products are introduced into the marketplace 

    Pat Beers Block, MDEd, BS, BS, CCRP

    Lecturer

    As a lecturer for Rutgers University, School of Health Professions, Department of Health Informatics, Pat develops and presents courses for the School’s Master degree program in Clinical Trials (2010-present).  From February 2010-12, Pat served as Vice President of Regulatory Policy within the Regulatory Compliance Team for Medidata Solutions Worldwide. In this capacity, Pat assisted Medidata in its understanding of local and international regulations related to GCP and electronic data capture.  Prior to joining Medidata, Pat held increasingly more responsible positions during her 33 year career with the US Food and Drug Administration.  Pat has been a regular contributor to programs developed by professional organizations including SOCRA and eClinical Forum.   Pat received the Distinguished Career Service Award from FDA at her retirement and is a member of Phi Kappa Phi and Alpha Zetta honor societies.  Pat is currently certified by SOCRA as a Clinical Research Professional (CCRP) and serves on the Board of Directors for SOCRA.

  • Part II - Informed Consent for Research: The Importance of Quality for Understanding and Decision-Making

    Contains 5 Component(s), Includes Credits

    This talk will review the new common rule definition of vulnerable subjects including "individuals with impaired decision making ability." It will discuss why inclusion of this vulnerable population is needed in research studies, especially for diseases such as Alzheimer's research. Finally, it will review the ethical guidelines and discuss practical strategies for obtaining informed consent for subjects who may lack decision making capacity.

    This talk will review the new common rule definition of vulnerable subjects including "individuals with impaired decision making ability." It will discuss why inclusion of this vulnerable population is needed in research studies, especially for diseases such as Alzheimer's research. Finally, it will review the ethical guidelines and discuss practical strategies for obtaining informed consent for subjects who may lack decision making capacity.

    LEARNING OBJECTIVES

    At the completion of the webinar, participants should be able to:

    Discuss the requirements for Informed Consent and HIPAA authorization for human subjects research.

    Recognize vulnerable populations and discuss ethical considerations and appropriate mechanisms for obtaining informed consent.

    Discuss strategies to ensure high-quality, high understanding in informed consent discussions.

    Laura Holtz, MS, CCRP

    Senior Research Manager

    Laura R. Holtz, MS, CCRP, is a Senior Research Manager at Indiana University Center for Aging Research and Regenstrief Institute.  Her experience managing multiple research trials includes projects with cognitively impaired seniors in the community and nursing facilities. Her coordination of the Indiana University Purdue University at Indianapolis (IUPUI) RESPECT Center annual conference includes facilitating continuing education focused on palliative and end-of-life communication. As a research staff advocate, Laura co-chairs the Indianapolis chapter of SOCRA, the Society of Clinical Research Associates which provides education opportunities for staff to become Certified Clinical Research Professionals (CCRP).  She is a trainer on topics including: Informed Consent, research interviews, enrolling vulnerable populations, and research project management topics at Indiana University and Indiana Clinical and Translational Sciences Institute (CTSI). Her dedication to research education earned her seat on the SOCRA Board of Directors.

  • Part I - Informed Consent for Research: Operationalizing the Process

    Contains 5 Component(s), Includes Credits

    This talk will review the new common rule definition of vulnerable subjects including "individuals with impaired decision making ability." It will discuss why inclusion of this vulnerable population is needed in research studies, especially for diseases such as Alzheimer's research. Finally, it will review the ethical guidelines and discuss practical strategies for obtaining informed consent for subjects who may lack decision making capacity.

    This talk will review the new common rule definition of vulnerable subjects including "individuals with impaired decision making ability." It will discuss why inclusion of this vulnerable population is needed in research studies, especially for diseases such as Alzheimer's research. Finally, it will review the ethical guidelines and discuss practical strategies for obtaining informed consent for subjects who may lack decision making capacity.

    LEARNING OBJECTIVES

    At the completion of the webinar, participants should be able to:

    • Discuss the requirements for Informed Consent and HIPAA authorization for human subjects research.
    • Recognize vulnerable populations and discuss ethical considerations and appropriate mechanisms for obtaining informed consent.
    • Discuss strategies to ensure high-quality, high understanding in informed consent discussions.

    Laura Holtz, MS, CCRP

    Senior Research Manager

    Laura R. Holtz, MS, CCRP, is a Senior Research Manager at Indiana University Center for Aging Research and Regenstrief Institute.  Her experience managing multiple research trials includes projects with cognitively impaired seniors in the community and nursing facilities. Her coordination of the Indiana University Purdue University at Indianapolis (IUPUI) RESPECT Center annual conference includes facilitating continuing education focused on palliative and end-of-life communication. As a research staff advocate, Laura co-chairs the Indianapolis chapter of SOCRA, the Society of Clinical Research Associates which provides education opportunities for staff to become Certified Clinical Research Professionals (CCRP).  She is a trainer on topics including: Informed Consent, research interviews, enrolling vulnerable populations, and research project management topics at Indiana University and Indiana Clinical and Translational Sciences Institute (CTSI). Her dedication to research education earned her seat on the SOCRA Board of Directors.

  • Sponsor Responsibilities

    Contains 5 Component(s), Includes Credits Recorded On: 03/27/2020

    This presentation will provide and overview of the Sponsor Responsibilities for conducting clinical research.

    This presentation will provide an overview of the sponsor responsibilities for conducting clinical research. The presentation will address sponsor responsibilities for regulatory submissions, site selection, documentation, and monitoring. Safety and regulatory reporting will also be discussed. As clinical trials expand throughout the globe, it is important to understand the regulatory and ethical responsibilities of the Sponsor. 


    LEARNING OBJECTIVES: 

    Describe sponsor responsibilities for conducting clinical research

    Discuss responsibilities for regulatory submissions, site selection, documentation and monitoring

    Discuss safety and regulatory reporting 


    Amy Jo Jenkins, MS, CCRP

    Executive Director/ Instructor

    Amy Jo Jenkins has 20+ years of experience working in clinical research and currently serves as the Executive Director of the Translational Research Institute at the University of Arkansas for Medical Sciences, where she also teaches courses in the Regulatory Science Program.  She earned her Masters of Science degree in Clinical Research Organization and Management from Drexel University and Bachelors of Science degree in Molecular Biology from Grove City College.  She has been a Certified Clinical Research Professional since 2010 and has served on the SOCRA Board of Directors since 2016.

  • CCRP RECERTIFICATION: Regulatory Updates for Clinical Research Professionals v.17.1

    Contains 3 Component(s), Includes Credits

    This learning module is intended to encourage the reader to maintain an understanding of current activities involved in the conduct of research involving human subjects. The module offers one SOCRA continuing education credit to those who complete the review and correctly answer 10 of the 11 questions. The module is offered at no cost as a public service. **This module does not work in Internet Explorer at this time**

    This learning module is intended to encourage the reader to maintain an understanding of current activities involved in the conduct of research involving human subjects. The module offers one SOCRA continuing education credit to those who complete the review and correctly answer 10 of the 11 questions.

    The module is offered at no cost as a public service.

    **This module does not work in Internet Explorer at this time**

    Upon completion of this course, the attendee should be able to discuss recent issues, changes, and/or updates in the regulatory environment.

    SOCRA's Education Committee

    on behalf of Society of Clinical Research Associates, Inc

    SOCRA's Education Committee has created this module to help clinical research professionals stay updated on recent changes in the regulatory environment.

  • Want to Write a Research Protocol? What to Consider, Where to Start & How to Create a Protocol Draft

    Contains 5 Component(s), Includes Credits

    JoAnn Mick, PhD, RN, NEA-BC, Nurse Researcher, Memorial Hermann - Texas Medical Center This presentation will provide information on the purpose and components of a research protocol and helpful strategies for writing a protocol draft with an Institutional Review Board reviewer’s perspective in mind. Three steps to writing an abstract, the difference between a study purpose and research question, and how to synthesize a review of literature that includes justification for conducting a study will be described. Other information will include: description of a critical thinking path for selecting appropriate data collection methodologies, describing risks and benefits to human subjects, and inclusion of a dissemination plan in study design.

    Want to Write a Research Protocol? What to Consider, Where to Start & How to Create a Protocol Draft
    JoAnn Mick, PhD, RN, NEA-BC, Nurse Researcher, Memorial Hermann - Texas Medical Center

    This presentation will provide information on the purpose and components of a research protocol and helpful strategies for writing a protocol draft with an Institutional Review Board reviewer’s perspective in mind. Three steps to writing an abstract, the difference between a study purpose and research question, and how to synthesize a review of literature that includes justification for conducting a study will be described. Other information will include: description of a critical thinking path for selecting appropriate data collection methodologies, describing risks and benefits to human subjects, and inclusion of a dissemination plan in study design.

    Continuing Education Credit Hours:
    SOCRA designates this educational activity for a maximum of 1 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)(TM). Physicians should claim credit commensurate with the extent of their participation in the activity.
    Accreditation Statements:
    CME for Physicians:
    The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
    CNE for Nurses:
    Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

  • The Journey from Point A to Point B: How to get from Clinical Inquiry to Conducting Nursing Research

    Contains 5 Component(s), Includes Credits

    JoAnn Mick, PhD, RN, NEA-BC, Nurse Researcher, Memorial Hermann - Texas Medical Center This presentation will define three types of clinical inquiry: evidence based practice (EBP), quality improvement (QI), and research. Steps nurses can take to move from having a practice idea or question to making a decision about conducting nursing research will be described. Information provided will include how to identify a problem/topic, how to view a problem/topic from a variety of practice angles, key sources of evidence to consider when conducting a literature review, making a decision to conduct research, and steps of the research process. The role of nurses in EBP, quality improvement, and research will be described in terms of how nurses can contribute to the body of knowledge that guides nursing practice.

    The Journey from Point A to Point B: How to get from Clinical Inquiry to Conducting Nursing Research
    JoAnn Mick, PhD, RN, NEA-BC,
    Nurse Researcher, Memorial Hermann - Texas Medical Center

    This presentation will define three types of clinical inquiry: evidence based practice (EBP), quality improvement (QI), and research. Steps nurses can take to move from having a practice idea or question to making a decision about conducting nursing research will be described. Information provided will include how to identify a problem/topic, how to view a problem/topic from a variety of practice angles, key sources of evidence to consider when conducting a literature review, making a decision to conduct research, and steps of the research process. The role of nurses in EBP, quality improvement, and research will be described in terms of how nurses can contribute to the body of knowledge that guides nursing practice.

    Continuing Education Credit Hours: SOCRA designates this educational activity for a maximum of 1 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)(TM). Physicians should claim credit commensurate with the extent of their participation in the activity. c

    Accreditation Statements:
    CME for Physicians:
    The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
    CNE for Nurses:
    Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

  • What You Should Know Before the FDA Arrives

    Contains 6 Component(s), Includes Credits Recorded On: 10/15/2012

    This online course is intended to provide access to training and continuing education that will promote quality clinical research, protect the welfare of research participants and improve global health.

    This online course is intended to provide access to training and continuing education that will promote quality clinical research, protect the welfare of research participants and improve global health. This Course will discuss the steps involved in an FDA inspection and will address best practices in responding to FDA questions. The faculty will discuss what the FDA is instructed to look for when conducting an inspection and review recommendations regarding what to do after the inspection. The FDA's Compliance Program Guidance Manuals will be explained.

    This is a 60 minute internet media player video of a voice over slide show.

    A quiz concluding the presentation will summarize the topic and evaluate your understanding of the material.

    LEARNING OBJECTIVES
    At the completion of the webinar, participants should be able to:
    1. Discuss the steps of an FDA audit.
    2. Discuss how to respond to FDA questions
    3. Have an understanding of the FDA's Compliance Program Manuals
    4. Understand what the FDA auditor is looking for.
    5. Discuss how to review recommendations from the FDA after an Audit.

    Harvey M. Arbit, PharmD, MBA, RAC, CCRP

    Director of the IND/IDE Assistance Program

    Harvey is at the University of Minnesota Academic Health Center where he is the director of the IND/IDE Assistance Program in the Office of Clinical Research and is adjunct associate professor in the College of Pharmacy. Prior to entering academia Harvey has over 30 years experience in the pharmaceutical and medical device industries where he held director and vice president level positions in the areas of regulatory affairs, clinical research, quality assurance, and product development. He has held positions at Baxter Travenol, 3M, Upsher-Smith, SmithKline Beecham, and Coloplast.


    He received his Bachelor of Science degree in pharmacy from Albany College of Pharmacy, PharmD degree from Duquesne University and MBA from Northern Illinois University. He completed a residency in clinical pharmacy at Mercy Hospital in Pittsburgh. He is Regulatory Affairs Certified and is a Certified Clinical Research Professional. Harvey also serves on the steering committee of the Clinical Trials Transformation Initiative.


    He is a frequent presenter on the topic of investigator-initiated drug and device clinical research at SOCRA meetings and other venues.

    SOCRA designates this educational activity for a maximum of 1 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)(TM). Physicians should claim credit commensurate with the extent of their participation in the activity.

    Accreditation Statements:
    CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

    CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation

    Termination Date 10/15/19

  • cGMP for Investigational New Drugs (IND) in Phase I Clinical Trials

    Contains 6 Component(s), Includes Credits Recorded On: 10/15/2012

    This online course is intended to provide access to training and continuing education that will promote quality clinical research, protect the welfare of research participants and improve global health.

    This online course is intended to provide access to training and continuing education that will promote quality clinical research, protect the welfare of research participants and improve global health. All drugs manufactured for use in clinical trials must comply with Good Manufacturing Practices. Drugs for Phase I clinical studies must comply with statutory CGMP. Drugs for human use must not be adulterated. The manufacturer must assure the drug is safe and has the identity, strength, quality, and purity which it is represented to possess. The FDA's guidance document covering this topic will be discussed.

    This is a 60 minute internet media player video of a voice over slide show.

    A quiz concluding the presentation will summarize the topic and evaluate your understanding of the material.


    LEARNING OBJECTIVES
    At the completion of the webinar, participants should be able to:
    1. Discuss the FDA's guidance document covering CGMP for clinical trials .

    Harvey M. Arbit, PharmD, MBA, RAC, CCRP

    Director of the IND/IDE Assistance Program

    Harvey is at the University of Minnesota Academic Health Center where he is the director of the IND/IDE Assistance Program in the Office of Clinical Research and is adjunct associate professor in the College of Pharmacy. Prior to entering academia Harvey has over 30 years experience in the pharmaceutical and medical device industries where he held director and vice president level positions in the areas of regulatory affairs, clinical research, quality assurance, and product development. He has held positions at Baxter Travenol, 3M, Upsher-Smith, SmithKline Beecham, and Coloplast.


    He received his Bachelor of Science degree in pharmacy from Albany College of Pharmacy, PharmD degree from Duquesne University and MBA from Northern Illinois University. He completed a residency in clinical pharmacy at Mercy Hospital in Pittsburgh. He is Regulatory Affairs Certified and is a Certified Clinical Research Professional. Harvey also serves on the steering committee of the Clinical Trials Transformation Initiative.


    He is a frequent presenter on the topic of investigator-initiated drug and device clinical research at SOCRA meetings and other venues.

    SOCRA designates this educational activity for a maximum of 1 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)(TM). Physicians should claim credit commensurate with the extent of their participation in the activity.


    Accreditation Statements:
    CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.


    CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.


    Termination Date 10/15/19