Hello,
ISO 14155 has a list of essential documents in Annex E. This would be the medical device equivalent of a drug trial master file. Two questions: how is a medical device trial master file different from an ICH-GCP trial master file? Is a sponsor also responsible for preparing the investigator binder in addition to a sponsor binder and all documentation used during the trial? Note: there is no delegation to a CRO .
Thanks.
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Karen Zhou
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