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​​​​A. Background & Definitions

to be added

​B. Guidance & Expectations​

  • Verifies in real time that the requirements for quality of the study related activities have been fulfilled according to study protocol
  • Ensures research team's compliance with the study protocol and the complete and acccurate documentation of the study
  • Checks data integrity and sample tracebility and reports results to study director; verification of study protocol adherence; follow up on study protocol deviations​​​​

​C. Resources

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Next item: 1.5.3 Management of resources​​ ​