Skip to main content
Data, Documentation & Clinical Systems

Data Review and Reconciliation: Prepare for Database Lock

Coming soon

Work unresolved issues down to a defensible recommendation on whether a study is ready to lock.

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

Advanced · Self-paced

Data review and reconciliation artwork: listings and charts on dual monitors moving from flagged discrepancies to a locked database, in BORAKA navy and teal.

What this course covers.

Who it is for
Data management, study management and monitoring staff.
What you will be able to do
Produce a discrepancy tracker and readiness recommendation from fictional datasets and unresolved issues.
What you will produce
A discrepancy tracker and a lock readiness recommendation.
Systems referenced
EDC

Topics

  • Data cleaning
  • Reconciliation
  • Open queries
  • Lock readiness

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.