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  • 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 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.


    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.

  • ICH E6 (R2): From the site’s perspective

    Contains 5 Component(s), Includes Credits Recorded On: 11/28/2017

    This presentation will address the ICH GCP E6 (R2) amendments and additions to the investigator responsibilities at a research site as well as best practices to meet those requirements.

    ICH E6 (R2): From the site’s perspective

    The International Council for Harmonisation (ICH) published a revision to GCP E6 based on feedback from the global clinical research community, advancements in technology and risk management developments. ICH states that the goal of the changes is to “encourage implementation of improved and more efficient approaches to clinical trial design, conduct oversight, recording, and reporting while continuing to insure human subject protection and data integrity”. This presentation will address the amendments and additions to the investigator responsibilities at a research site as well as best practices to meet those requirements.

    This is a 30 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:

    • Describe the ICH GCP E6 (R2) changes for Investigator Responsibilities at a research site
    • Understand the rationale for changing the fundamentals of the monitoring process
    • Recognize how the (R2) Risk Base Monitoring will affect the Site

    James Simmer BSN, MBA

    President and Founder

    Jim Simmer is President and Founder of Research Answers. A clinical research consulting company that specializes in innovative solutions that benefit both Sponsor and Investigative Sites. He has over 13 years experience in clinical research and a MBA from Temple University. He built Research Answers on the foundation of personalized, well planned, and dedicated delivery of services.

    Prior to founding Research Answers, Jim held diverse management positions for both pharma companies and research sites that has allowed him to gain a unique perspective in the Industry. A frequent lecturer on advanced site management topics, he has been a presenter at the Association of Clinical Research Professionals Global Conference and a speaker for the Society of Clinical Research Associates (SOCRA).

  • The Impact of Risk Based Monitoring from the Site Perspective

    Contains 5 Component(s), Includes Credits

    Most site personnel have been exposed to the term risk based monitoring (RBM). But what is meant by RBM and where did the term come from. In addition to explaining the definition and rationale for RBM, this presentation will demonstrate how it will be implemented by Sponsors and what the downstream effects will be to sites. Lastly, the presentation will provide insight into what sites need to do to best prepare for this new monitoring paradigm.

    Risk Based Monitoring from the Site Perspective

    Most site personnel have been exposed to the term risk based monitoring (RBM).  But what is meant by RBM and where did the term come from. In addition to explaining the definition and rationale for RBM, this presentation will demonstrate how it will be implemented by Sponsors and what the downstream effects will be to sites.  Lastly, the presentation will provide insight into what sites need to do to best prepare for this new monitoring paradigm.

    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:

    • Understand the rationale for changing the fundamentals of the monitoring process
    • Describe what is Risk Based Monitoring
    • Recognize how Risk Base Monitoring will affect the Site
    • Identify current Site processes that will need to be altered to accommodate Risk Based Monitoring

    James Simmer BSN, MBA

    President and Founder

    Jim Simmer is President and Founder of Research Answers. A clinical research consulting company that specializes in innovative solutions that benefit both Sponsor and Investigative Sites. He has over 13 years experience in clinical research and a MBA from Temple University. He built Research Answers on the foundation of personalized, well planned, and dedicated delivery of services.

    Prior to founding Research Answers, Jim held diverse management positions for both pharma companies and research sites that has allowed him to gain a unique perspective in the Industry. A frequent lecturer on advanced site management topics, he has been a presenter at the Association of Clinical Research Professionals Global Conference and a speaker for the Society of Clinical Research Associates (SOCRA).

  • 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.

  • 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.

  • IND / IDE Assistance

    Contains 5 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. Why provide IND/IDE assistance? This presentation will discuss program start up and program successes.

    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 IND/IDE program start up and program successes.

    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

  • 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