Retention period of study documents by ramchandavolu


									                                           00:43:48 / 00:49:10

that records should be retained: Until at least 2 years after
the approval of a marketing application in an ICH region,
Until there are no pending or contemplated marketing
applications in an ICH region, or Until at least 2 years have
elapsed since the formal discontinuation of clinical
development of the investigational product. Some                 [00:41:36] Archiving Data/Record Retention
countries may have slightly different regulations, For
                                                                 [00:41:45] What - Types of Records
example, the FDA regulations state that
                                                                 [00:42:34] By Whom - Custodian
                                                                 [00:43:35] How Long - Retention Period
                                                                 [00:45:17] Record Retention
                                                                 [00:45:46] Security of Archived Data

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