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 == | ||
| − | + | * 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; | |
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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 | ||
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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 | ||
| − | + | * 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. | |
| − | * responsibility for prompt recording of raw data after their generation in compliance with Good Research Practice and study protocol. Documentation of study | ||
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== C. Resources == | == C. Resources == | ||
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| − | back to [[ | + | back to [[Toolbox]] |
| − | Next item: [[1..2.6 Supporting team]] | + | Next item: [[1.5.2.6 Supporting team]] |
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
back to Toolbox
Next item: 1.5.2.6 Supporting team
