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15th Sep 2017, 03:18 PM
#4
"Do the lab staff also need to have GCP training? Is it possible that these labs get inspected?" - What training is needed and how it is documented depends to some degree on the nature of the study. Some protocols need extensive training and others may need minimal, also dependent upon the background and experience of study staff. The regulations require that sponsors choose investigators qualified by training and experience. The regulations also require that investigators commit themselves to personally conduct or supervise the investigation.
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