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Data, Documentation & Clinical Systems

TMF Quality Control: Reconstruct a Complete, Traceable Trial Record

Coming soon

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

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

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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.

What this course covers.

Who it is for
TMF, quality, site and study management staff.
What you will be able to do
Review a mock trial master file, distinguish meaningful gaps from non-applicable items and build a remediation tracker.
What you will produce
A TMF gap review and remediation tracker.
Systems referenced
Electronic trial master file (eTMF)

Topics

  • Completeness
  • Timeliness
  • Traceability
  • Remediation

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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