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April 15, 2003 

Pros: Compliant with requirement that investigator maintain control of data
Cons: Extremely burdensome to manage and maintain
Pros: Far fewer standard operating procedures required at the site level
Cons: May be considered non-compliant with regulatory requirement that investigator maintain control of data (i.e., data wouldn't be ALCOA*)

Trusted Third Party (TTP)
Pros: Relieves site of data-administration burden, while providing investigator with access
Cons: FDA's current thinking on this approach still unknown; sponsor would pay for TTP, raising conflict-of-interest concerns * attributable, legible, contemporaneous, original, accurate

Back to E-Sourcing: Covering the Regulatory Bases 

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