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Data, Documentation & Clinical Systems

Clinical Systems Literacy: Follow the Information Across EDC, CTMS, and eTMF

Coming soon

Learn where each piece of study information belongs, and what happens when it is only in one place.

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

Clinical systems literacy artwork: EDC, CTMS and eTMF screens connected by document and data flows, in BORAKA navy and teal.

What this course covers.

Who it is for
Anyone working across more than one clinical system.
What you will be able to do
Map information flow and explain where updates, records and reconciliation activities belong.
What you will produce
An information flow map across study systems.
Systems referenced
EDC, CTMS, eTMF

Topics

  • System purpose
  • Information flow
  • Reconciliation
  • Record ownership

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.

  • Source-to-EDC data quality artwork: source documents and lab results reconciled against an EDC screen with queries and discrepancy flags, in BORAKA navy and teal.
    Coming soon

    Source-to-EDC quality

    Compare source records with entered data, work out what really happened, and answer queries with evidence.

  • TMF quality control artwork: trial master file binders beside a laptop eTMF index with version status checks and a remediation tracker, in BORAKA navy and teal.
    Coming soon

    TMF quality control

    Review a mock trial master file and tell a real gap apart from something that simply does not apply.

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

    Site activation pack

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