Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV

Document information
Reference	USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007
Validity area	USA
Scope(s)	G
Document name	FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations
Version / Revision	May-2007
Status	Current
Document type	Official recommendation
Language(s)	EN
Description	Guidance for Industry Computerized Systems Used in Clinical Investigations
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 4 — Unit 4.2.2
Scope	G
Document part	IV
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Source documents, Electronic records, Investigator record retention, Trial site, FDA

Content

IV. RECOMMENDATIONS [...] C. Source Documentation and Retention When original observations are entered directly into a computerized system, the electronic record is the source document. Under 21 CFR 312.62, 511.1(b)(7)(ii) and 812.140, the clinical investigator must retain records required to be maintained under part 312, § 511.1(b), and part 812, for a period of time specified in these regulations. This requirement applies to the retention of the original source document, or a copy of the source document.

When source data are transmitted from one system to another (e.g., from a personal data assistant to a sponsor’s server), or entered directly into a remote computerized system (e.g., data are entered into a remote server via a computer terminal that is located at the clinical site), or an electrocardiogram at the clinical site is transmitted to the sponsor’s computerized system, a copy of the data should be maintained at another location, typically at the clinical site but possibly at some other designated site. Copies should be made contemporaneously with data entry and should be preserved in an appropriate format, such as XML, PDF or paper formats.