1.5.2.5 Research team

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​​​​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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