Is ICH-GCP (Good Clinical Practice) followed in New Zealand?
Good Clinical Research Practice guidelines based on ICH-GCP have been followed in New Zealand since 1996. New Zealand-specific GCRP Guidelines have been available since 1998. More information can be obtained from Medsafe. New Zealand trial sites and personnel are familiar with the compliance requirements of ICH-GCP and the Declaration of Helsinki. Top 3. Is approval needed from Ethics Committees (EC’s)/IRB’s for a study in New Zealand, and if so, how long does it take, how often do EC’s meet, and is there a combined process in the case of multi-centre studies? Ethics Committee approval is required for all research involving humans. Only one ethics committee review is required per study in New Zealand. If all sites for a study are within one region, that region’s committee deals with it. If sites extend across more than one region, it is dealt with by the national committee only. It takes 1-2 months from submission to full approval. It’s not a difficult process, but it’s important to kn
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