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Labs, Technology & Complex Trial Operations

Protocol Amendments: Control Change Across Sites, Systems, and Vendors

Coming soon

Work out everything an amendment touches, then track it to done across every affected party.

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

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Illustration of an original and amended protocol document with arrows to affected downstream areas

What this course covers.

Who it is for
Study managers, start-up staff and site teams implementing amendments.
What you will be able to do
Create an impact assessment and implementation tracker covering documents, training, systems and operational changes.
What you will produce
An amendment impact assessment and implementation tracker.
Systems referenced
EDC, eTMF

Topics

  • Impact assessment
  • Version control
  • Retraining
  • Implementation tracking

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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