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Data, Documentation & Clinical Systems

Regulatory Document Readiness: Build a Site Activation Pack

Coming soon

Assemble a fictional site document package and quality-check it before anyone else has to.

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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Regulatory document readiness artwork: a site activation pack binder with IRB approval, protocol, investigator brochure and readiness checklist, in BORAKA navy and teal.

What this course covers.

Who it is for
Start-up, regulatory and site staff preparing activation documents.
What you will be able to do
Assemble and quality-check a fictional site document package, including version, approval and completeness checks.
What you will produce
A site activation document pack with a completeness check.
Systems referenced
No specific system access is required for this course.

Topics

  • Essential documents
  • Version control
  • Approvals
  • Completeness checks

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.

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