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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.

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    Roles and Responsibilities under ICH GCP

    Describes the roles and responsibilities of the different parties involved in initiating, conducting, and overseeing clinical trials according to ICH Good Clinical Practice. After explaining the need for ICH GCP, the module describes the part played by sponsors, investigators and IRB/IEC. The roles of other key contributors to the clinical trial process are also described.

    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

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

    Description

    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
    • Desccribe 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’
    Module Features:

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

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