1.5.2.5 Research team

A. Background & Definitions

to be added

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.

to be added

back to Toolbox