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significant. Finally, always remember that subject safety is
the most important concern. The minimum information
required in each subject's medical file includes the:
Protocol number, Date of the signed informed consent,
Current and past medical history, Dates of all visits,
Dispensing details for the investigational product - what        [00:23:18] Source Data Verification (SDV)
medication was dispensed to the subject, subject
                                                                 [00:24:11] Access to Source Documents
compliance, and what product
                                                                 [00:25:17] Investigator's Responsibilities
                                                                 [00:26:24] Investigator's Responsibilities - Medical Records
                                                                 [00:27:24] Sponsor-provided Progress Notes
                                                                 [00:28:09] Access to Medical Records

				
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posted:4/26/2010
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