FDA Guidance on Computerized Systems Used in Clinical Investigations

Scope
Computerized systems that contain data that support a marketing application

• Case histories
• Analytical test results (e.g., LIMS)
• Data captured from analytical instruments
• Electronic transcription of hardcopy source data

it Does not apply to Computerized medical devices*
Study Protocols
•Identify computerized system use within the trial process
•Computerized systems must:
–Satisfy process requirements defined in study protocol
–Have built-in error prevention
•Challenges
–More complicated protocols
–Some automated processes may not be defined at protocol authoring stage – unnecessary protocol revisions
•Potential Solutions
–Include only high level detail in study protocol
–Maintain detailed computerized process map outside study protocol
SOPs and System Documentation

•Specific to computerized system
–Setup/Installation instructions
–Operating manual
–Validation
–Data collection and handling
–System maintenance
–Security controls
–Change control
–Backup/Restore
–Disaster recovery/contingency planning
–Data collection contingencies
–Training
–Roles and responsibilities

•Challenges
–Guidance states “Such SOPs should be maintained either on-site or be remotely accessible through electronic files as part of the specific study records, and the SOPs should be made available for use by personnel and for inspection by FDA.”
•Potential Solutions
–Considerations for which SOPs are implemented at the site
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