Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 III

Document information
Reference	USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015
Validity area	USA
Scope(s)	G
Document name	FDA Guidance for Industry - Computerized Systems Used in Clinical Trials
Version / Revision	13-Apr-2015
Status	Current
Document type	Official recommendation
Language(s)	EN
Description	Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS
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	III
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Source documents, Electronic records, Archiving, Documentation

Content

III. GENERAL PRINCIPLES [...] C. Source documents should be retained to enable a reconstruction and evaluation of the trial. D. When original observations are entered directly into a computerized system, the electronic record is the source document. E. The design of a computerized system should ensure that all applicable regulatory requirements for recordkeeping and record retention in clinical trials are met with the same degree of confidence as is provided with paper systems. F. Clinical investigators should retain either the original or a certified copy of all source documents sent to a sponsor or contract research organization, including query resolution correspondence. G. Any change to a record required to be maintained should not obscure the original information. The record should clearly indicate that a change was made and clearly provide a means to locate and read the prior information. H. Changes to data that are stored on electronic media will always require an audit trail, in accordance with 21 CFR 11.10(e). Documentation should include who made the changes, when, and why they were made. [...]