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Digital Learning Catalog

DIA Learning: 2018 eLearning Soultions

Good Clinical Practice eLearning Module

Good Clinical Practice eLearning Module

The Good Clinical Practice eLearning module provides the basic knowledge required to conduct clinical trials, including information about subject safety, regulations, and the practicalities of performing clinical research studies. This module includes information about the recently adopted ICH GCP E6(R2) guideline. Learn through an interactive case study, knowledge checks, and flashcards.

Featured Topics
  • GCP Roles, Terms and Origins
  • GCP Requirements, Regulations, Guidances, and History
  • The Role of the Investigator
  • The Role of the Study Staff, Sponsor, and IRB
  • Aspects of GCP: Informed Consent, Adverse Event Handling and Reporting

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  • Related Products

    Clinical Trial Management Comprehensive eLearning Bundle

    This eLearning bundle includes the Clinical Trial Fundamentals eLearning Program and the Informed Consent: Comprehensive Concepts and Components module.

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    Clinical Trial Fundamentals eLearning Program

    This eLearning program is designed to provide a practical context to help clinical research professionals learn about conducting clinical trials. Using an interactive case study with realistic scenarios designed to illustrate the learning points, the program follows the activities of a fictitious clinical investigator and her staff as they conduct a clinical trial. The program includes three modules that focus on study preparation, study initiating, and conducting a study.

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    Informed Consent: Comprehensive Concepts and Components eLearning Module

    This comprehensive module provides the key concepts of informed consent. It explains the components of a complete and appropriate consent form as specified by the International Conference on Harmonisation (ICH) and the US Food and Drug Administration (FDA), as well as guidance for the creation and appropriate wording of these components. It also includes a discussion on the benefits and concerns with electronic informed consent, and presents publications and projects that explore the use of eConsent.

    Featured topics
    • Determining When Informed Consent Is Necessary
    • Comprehension Guidelines
    • Overview of Elements of Consent
    • Writing the Introduction and Purpose Statement
    • Explaining Procedures
    • Explaining Risks and Benefits
    • Explaining Alternatives, Cost, and Compensation
    • Explaining Confidentiality and Subject Rights
    • Storage of Specimens
    • Contact Information, Consent Statements, and Signatures
    • Long Form versus Short Form, and Tips for Administering Consent
    • Changes to Informed Consent Under HIPAA

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