Difference between revisions of "1.5.2.5 Research team"

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== B. Guidance & Expectations​ ==
 
== B. Guidance & Expectations​ ==
* must be knowledgeable to apply the needed principles of Good Research Practice to the study; responsible for execution of the study plan and appropriate documentation;
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* must be knowledgeable to apply the needed principles of Good Research Practice to the study; responsible for execution of the study protocol and appropriate documentation;
 
* effective communication to study director and quality professionals prior and during the study; especially study protocol deviations; communication of relevant health or medical conditions that may affect the study to appropriate person
 
* effective communication to study director and quality professionals prior and during the study; especially study protocol deviations; communication of relevant health or medical conditions that may affect the study to appropriate person
* responsibility for prompt recording of raw data after their generation in compliance with Good Research Practice and study protocol. Documentation of study plan deviations; seek training, as needed, to perform assigned study responsibilities. ​
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* responsibility for prompt recording of raw data after their generation in compliance with Good Research Practice and study protocol. Documentation of study protocol deviations; seek training, as needed, to perform assigned study responsibilities. ​
  
  

Latest revision as of 19:47, 23 March 2021

​​​​A. Background & Definitions

to be added


B. Guidance & Expectations​

  • must be knowledgeable to apply the needed principles of Good Research Practice to the study; responsible for execution of the study protocol and appropriate documentation;
  • effective communication to study director and quality professionals prior and during the study; especially study protocol deviations; communication of relevant health or medical conditions that may affect the study to appropriate person
  • responsibility for prompt recording of raw data after their generation in compliance with Good Research Practice and study protocol. Documentation of study protocol deviations; seek training, as needed, to perform assigned study responsibilities. ​


​C. Resources

to be added



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