Types of investigator systems to be evaluated

Any system that is originating patient data that is used in a regulated clinical trial should be evaluated for its suitability.

Please note: Only areas / modules of an electronic system that are being used to enter, store, manage, or otherwise handle records that will be used for clinical research need to be evaluated. For example, the portion of an EHRS that might be used to handle insurance claims would not need to be evaluated.

This is an example list and not an exhaustive list.

  • Electronic Health Record Systems (EHRS)
  • Laboratory Systems Diagnostic
  • Testing Systems
  • Imaging Systems (e.g. xray, catscan)
  • Pharmacy systems (if used to hold records of patient medication dosing)
  • Radiology Systems

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