Difference between revisions of "1.5.2.7 Quality professionals"

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== ​​​​A. Background & Definitions ==
 
== ​​​​A. Background & Definitions ==
 
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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 plan
 
* 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 plan adherence; follow up on study plan deviations​​​​
 
 
  
  
 
== ​C. Resources ==
 
== ​C. Resources ==
 
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to be added
 
 
tba
 
 
 
  
  

Revision as of 12:37, 5 September 2020

​​​​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 plan
  • 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​​​​


​C. Resources

to be added



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Next item: 1.5.3 Management of resources​​ ​