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The US Food & Drug Administration (FDA) final Guidance for Industry
"Computerized Systems Used in Clinical Trials" was published in May 2007.
This document provides recommendations regarding the use of computerized
systems in clinical investigations. It applies to records in electronic form
that are used to create, modify, maintain, archive, retrieve, or transmit
clinical data required to be maintained or submitted to the FDA.
This guidance supersedes the guidance with the same name from April 1999
and finalises the draft Guidance for Industry from September 2004. It also
supplements the Guidance for Industry on Part 11, Electronic Records;
Electronic Signatures – Scope and Application, dated August 2003, when
applying these guidances to source data generated at clinical study sites.
FDA's acceptance of data from clinical trials for decision-making
purposes depends on the authority's ability to verify the quality and
integrity of the data during FDA on-site inspections and audits. Topics that
are covered in this Guidance are:
- Study Protocol
- Standard Operating Procedures (Appendix A lists 11 processes that should be included in SOPs)
- Source Documentation and Retention
- Limited Access
- Audit Trails
- Date/Time Stamps
- Direct Entry of Data
- Retrieving Data
- System Documentation
- System Controls
- Change Controls
A special emphasis is on Training of Personnel:
"Those who use computerized systems must determine that individuals who
develop, maintain, or use computerized systems have the education, training
and experience necessary to perform their assigned task."
The complete Guidance for Industry can be found here:
http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0440-gdl0002.pdf
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