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

{{ReferenceData
|has_document=Document:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013
|module=4
|unit=4.2.3
|scope=G
|doc_part=II
|language=EN
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00150-Sou-eUr ++ TAG-00129-Dat-ali ++ TAG-00320-Foo-eri ++ TAG-00340-Req-nfo
|tags_display=[[Glossary:TAG-00150-Sou-eUr|Source documents]], [[Glossary:TAG-00129-Dat-ali|Data integrity]], [[Glossary:TAG-00320-Foo-eri|FDA]], [[Glossary:TAG-00340-Req-nfo|Requirements]]
|comment=ALCOA principles for source data (FDA)
|content=[…]
Source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA) and must meet the regulatory requirements for recordkeeping.
[…]
}}