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Foundations & Operational Judgment

Clinical Research Workflow: Who Owns What, and When?

Coming soon

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

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 study roles at site, sponsor, CRO and vendor connected in a cycle around a central protocol document

What this course covers.

Who it is for
People entering clinical research, and anyone who only sees one part of the study.
What you will be able to do
Build a responsibility and handoff map showing how a fictional study moves between site, sponsor, CRO and vendors.
What you will produce
A responsibility and handoff map for a fictional study.
Systems referenced
No specific system access is required for this course.

Topics

  • Study roles
  • Handoffs
  • Oversight
  • Delegation
  • Escalation paths

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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Also in Foundations & Operational Judgment.

  • 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 an ICH E6(R3) guidance book with a participant protection shield, balanced scales and a magnifier
    Coming soon

    GCP in real work

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

  • 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.