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Foundations & Operational Judgment

GCP in Real Work: ICH E6(R3) Decision-Making

Coming soon

Work through the everyday decisions where good clinical practice is either applied or quietly skipped.

This course is still being built. Lessons are not available yet, and there is no enrollment, payment or certificate for it at this stage.

Foundation · Self-paced

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Illustration of an ICH E6(R3) guidance book with a participant protection shield, balanced scales and a magnifier

What this course covers.

Who it is for
Site, CRO and sponsor staff who want GCP as judgement, not recall.
What you will be able to do
Explain and document decisions involving participant protection, oversight, data reliability and proportionate quality controls.
What you will produce
A set of documented GCP decisions with the reasoning behind each one.
Systems referenced
No specific system access is required for this course.

Topics

  • Participant protection
  • Oversight
  • Data reliability
  • Proportionate quality
  • Documentation

All scenarios used in Academy courses are fictional practice material. Course work is practice, not employment experience, and it is not a verified competency result.

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Register your interest in this course.

Tell us a little about where you are now. Registering interest is not an enrollment and does not reserve a place.

Also in Foundations & Operational Judgment.

  • Illustration of study roles at site, sponsor, CRO and vendor connected in a cycle around a central protocol document
    Coming soon

    Clinical research workflow

    Follow a fictional study across site, sponsor, CRO and vendors, and see where responsibility actually sits at each step.

  • Illustration of a protocol binder beside a visit schedule grid, a checklist and a route map of study milestones
    Coming soon

    Protocol to practice

    Turn a fictional protocol into the practical plan a study team can actually run from.

  • Illustration of a study inbox and urgency grid on two screens beside a clock and a plan, prioritize, execute checklist
    Coming soon

    Prioritization under pressure

    Decide what comes first when participant, safety, documentation and timeline demands all arrive at once.