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Trial Management & Sponsor Operations

Clinical Trial Risk Management: Build a Decision-Ready Risk and Issue Log

Coming soon

Convert a messy study update into risks, issues, owners and the decisions that need making now.

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

Practitioner · Self-paced

Risk and issue log artwork: a risk register on screen with severity ratings, owners and target dates beside a risk assessment matrix, in BORAKA navy and teal.

What this course covers.

Who it is for
Study managers, leads and anyone reporting study status.
What you will be able to do
Turn a fictional study update into prioritized risks, active issues, owners, actions and escalation decisions.
What you will produce
A prioritized risk and issue log with owners and escalation decisions.
Systems referenced
No specific system access is required for this course.

Topics

  • Risk assessment
  • Issue management
  • Ownership
  • Escalation

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.

Register your interest in this course

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.

  • Study start-up artwork: an activation workflow with a flagged bottleneck, readiness checklist, activation timeline and root cause analysis, in BORAKA navy and teal.
    Coming soon

    Study start-up

    See which start-up dependency is really holding activation, and sequence the recovery.

  • Trial budget artwork: planned versus actual cost tables, a variance chart and a change order status list, in BORAKA navy and teal.
    Coming soon

    Budgets and change orders

    Check what a budget assumed, find where reality diverged, and explain the difference in writing.

  • CRO and vendor oversight artwork: an all-green vendor performance dashboard being questioned, with site status maps and an investigation checklist, in BORAKA navy and teal.
    Coming soon

    CRO and vendor oversight

    Ask what a reassuring status report is not showing, and prepare the oversight conversation.