Table 2.

Flow of Data Through the System, from Contract Research Organizations (CROs) to Sponsors and the Food and Drug Administration (FDA)

CRO Task	Documents Transferred to Sponsor	Sponsor Tasks	Documents Transferred to FDA	FDA Tasks
Data file preparation	Data files	ESD preparation	ESDs	ESD import to the database
		Data file preparation and incorporation	Data files	ESD and data file import to the reviewer tool
		CDOC preparation	CDOCs	ESD, data file, and CDOC storage on LAN
				Review of application
Note: FDA indicates Food and Drug Administration; ESD, electronic submission document; CDOC, companion document; LAN, local area network.