1.5.2.7 Quality professionals: Difference between revisions

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== ​B. Guidance & Expectations​ ==
== ​B. Guidance & Expectations​ ==
* Verifies in real time that the requirements for quality of the study related activities have been fulfilled according to study plan
* 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
* 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 plan adherence; follow up on study plan deviations​​​​
* Checks data integrity and sample tracebility and reports results to study director; verification of study protocol adherence; follow up on study protocol deviations​​​​





Latest revision as of 19:46, 23 March 2021

​​​​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

to be added



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