Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II

Document Information

Document information
Reference	USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013
Validity area	USA
Scope(s)	G
Document name	FDA Guidance for Industry - Electronic Source Data in Clinical Investigations
Version / Revision	Sep-2013
Status	Current
Document type	Official recommendation
Language(s)	EN
Description	Guidance for Industry Electronic Source Data in Clinical Investigations
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details

Scope	G
Document part	II
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	ALCOA principles for source data (FDA)

Text

[…] Source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA) and must meet the regulatory requirements for recordkeeping. […]