essential documents

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documents serve to demonstrate the compliance of the
investigator, sponsor and monitor with the standards of
Good Clinical Practice and with all applicable regulatory
requirements. Most of the essential documents are
generated before the beginning of the clinical phase of a
trial. They are trial specific meaning that they are            [00:39:42] IRB/IEC Documents (2)
directly related to the trial. Most of these documents will
                                                                [00:41:39] Expedited Reviews
be used by all the
                                                                [00:43:31] Exemption from Requirements
                                                                [00:44:26] Essential Documents for the Conduct of a Trial
                                                                [00:45:11] Essential Documents - Time and Location
                                                                [00:45:49] Documents Required: Before Trial Begins- Filed at Site