SAE reporting to sponsor

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investigator reports an SAE to the sponsor, it must also be
reported to the IRB/IEC. If the sponsor notifies the
investigator of SAEs at other clinical sites, in the form of a
Safety Report (for example an IND safety report), these
must be reported to the IRB/IEC as well. When the
IRB/IEC receives safety notifications, they may require a          [00:24:21] AE Recording - Investigator Responsibilities
change to the informed consent form based on this new
                                                                   [00:25:00] Adverse Event CRF Page Example
information. The investigator must keep all
                                                                   [00:25:28] SAE Reporting - Investigator Responsibilities (1)
                                                                   [00:26:47] SAE Reporting - Investigator Responsibilities (2)
                                                                   [00:28:20] SAE Reporting - Investigator Responsibilities (3)
                                                                   [00:29:04] Financial Disclosure

				
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posted:4/26/2010
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