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Multiple Choice

Which activities are included in the term 'trial conduct' under ICH GCP?

Trial conduct covers everything done to run a study according to the protocol and GCP, from planning to final reporting. It includes planning the trial, initiating sites, performing the activities described in the protocol, recording data accurately, providing ongoing oversight and monitoring, evaluating the data as it accumulates, analyzing the results, and reporting the findings. This broad scope means that activities like recruiting patients are part of trial conduct because they occur during the initiating and performing phases, while marketing the product is outside the trial’s conduct, and budgeting, though related to trial management, isn’t itself a core trial-conduct activity. So the option listing planning, initiating, performing, recording, oversight, evaluation, analysis, and reporting best reflects what is included in trial conduct.

Trial conduct covers everything done to run a study according to the protocol and GCP, from planning to final reporting. It includes planning the trial, initiating sites, performing the activities described in the protocol, recording data accurately, providing ongoing oversight and monitoring, evaluating the data as it accumulates, analyzing the results, and reporting the findings. This broad scope means that activities like recruiting patients are part of trial conduct because they occur during the initiating and performing phases, while marketing the product is outside the trial’s conduct, and budgeting, though related to trial management, isn’t itself a core trial-conduct activity. So the option listing planning, initiating, performing, recording, oversight, evaluation, analysis, and reporting best reflects what is included in trial conduct.