1.5.2.5 Research team

​​​​A. Background & Definitions

tba

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;

• 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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​C. Resources

tba

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