Difference between revisions of "1.5.2.5 Research team"
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== A. Background & Definitions == | == A. Background & Definitions == | ||
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== B. Guidance & Expectations == | == B. Guidance & Expectations == | ||
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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 plan and appropriate documentation; | * 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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* 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 | ||
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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 plan deviations; seek training, as needed, to perform assigned study responsibilities. | * 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 == | == C. Resources == | ||
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Revision as of 12:35, 5 September 2020
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 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.
C. Resources
to be added
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Next item: 1.5.2.6 Supporting team
