Research samples

[Essaywriters]

"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.

[CQAO_GEN]

"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.

EMA Guidance : Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples

All staff involved in the analysis or evaluation of clinical trial samples should receive GCP training commensurate with their roles and responsibilities.
It is appropriate for laboratory staff to receive periodic GCP refresher training. Such training is especially important following changes to regulations and associated guidance documents.