1.5.2.5 Research team: Difference between revisions
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== A. Background & Definitions == | == A. Background & Definitions == | ||
to be added | |||
== 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; | |||
* must be knowledgeable to apply the needed principles of Good Research Practice to the study; responsible for execution of the study | |||
* 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 == | ||
to be added | |||
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back to [[Toolbox]] | 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