Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4.

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
Module	Module 4 — Unit 4.2.3
Scope	G
Document part	III 4.
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Electronic records, Audit trail, Case report form, Source documents, FDA

Content

III. Electronic Source Data […] 4. Modifications and Corrections Only a clinical investigator(s) or delegated clinical study staff should perform modifications or corrections to eCRF data. Modified and/or corrected data elements must have data element identifiers that reflect the date, time, originator and reason for the change, and must not obscure previous entries.11 A field should be provided allowing originators to describe the reason for the change (e.g., transcription error). Automatic transmissions should have traceability and controls via the audit trail to reflect the reason for the change. [...]