Essential Records Retention. The Investigator should maintain the essential clinical study documents (including CRFs, source documents, clinical drug disposition records, signed subject informed consent forms, AE reports and other regulatory documents) as required by the applicable national regulatory requirements. The Investigator is to take adequate measures to prevent accidental or premature destruction of these documents. In the event of accidental destruction, the Investigator should notify the Sponsor (or an authorized representative) immediately. Essential clinical study documents will be retained at least two (2) years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region OR at least two (2) years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents shall be retained for a longer period, however, if required by the applicable regulatory requirements or by an agreement with the Sponsor (or an authorized representative). The Investigator is required to notify the Sponsor (or an authorized representative) prior to changing the location or status of any essential clinical study documents. The Sponsor (or an authorized representative) will be responsible for informing the Investigator as to when these documents no longer need to be retained.
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