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Founded in 1998 in Dublin, Ireland, Skillpad's team of industry-experienced Subject Matter Experts and Consultants believes Pharma, Biopharma, and Life Science Industry manufacturing companies can achieve production excellence with improved performance, productivity & compliance, as well as reduced losses & down-time, if they have KNOWLEDGE CONSISTENCY in all critical areas of manufacturing operations.

With 25 years in business, and offices in Europe, the USA and Canada, Skillpad has helped customers all over the world with Life Science Industry Knowledge challenges. We are fully dedicated to the idea that Knowledge Consistency is more achievable than ever using the latest technology and advanced knowledge transfer and management tools.

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    • Roles and Responsibilities under ICH GCP

    An exploration of the principles and guidelines outlined in ICH Good Clinical Practice (GCP), focusing on the ethical and scientific standards necessary for conducting clinical trials. This module covers the roles of key parties involved in clinical trials, including sponsors, investigators, and Institutional Review Boards (IRBs), with an emphasis on the importance of informed consent. The module also details the trial protocol, a crucial document that guides clinical trial design and execution, ensuring both the protection of trial subjects and the integrity of the trial data.

    Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.

      Duration: 30 Mins
    Grade: Core Library

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    SKU: CTM-1101-SPL05-EN Category: Tag:

    Description

    • Gain Insight into GCP Principles: Examine the ethical standards and scientific integrity requirements of clinical trials to ensure the credibility and safety of trial data.
    • Recognize Roles and Responsibilities: Explore the responsibilities of sponsors, investigators, and Institutional Review Boards (IRBs) in conducting ethical and compliant clinical trials.
    • Understand Consent: Gain a clear understanding of the informed consent process, ensuring that trial subjects are well-informed, and their rights and safety are prioritized.
    • Follow Protocol and Maintain Compliance: Understand the role of the clinical trial protocol, including its design, content, and the steps required to meet regulatory standards and GCP guidelines.

    Learning Objectives

    • Understand and explain at an overview level the meaning of the term: Good Clinical Practices (GCP).
    • Describe the role and rights of participants in clinical trials.
    • Describe the roles and responsibilities of sponsors, investigators and IRB/IECs in clinical trials.
    • List the other key contributors in clinical trials.
    • Explain the principle of informed consent.
    • Describe the purpose, contents and development of the ‘Trial Protocol’.

    Keywords

    • Clinical Trials
    • Clinical Trial Data
    • Clinical Trial Protocol
    • Good Clinical Practice (GCP)
    • Human Subjects Protection
    • ICH GCP
    • Independent Ethics Committee (IEC)
    • Informed Consent
    • Institutional Review Board (IRB)
    • Sponsors

    Module Features

        Animations
       Voice Over
        Knowledge Checks
        Assessments
       SCORM/AICC compatible
        Full Screen

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