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- Published
- Updated
- Sources checked
Source data verification requires both a justified review scope and workable access. Agree the source location, authorised viewer and privacy arrangements before promising remote review or a fixed percentage of checks.
Define sources and review scope
Distinguish source data review, which examines processes and context, from verification against transcribed values. Identify the authoritative source for critical assessments, including electronic health records and external reports. Do not assume a printed extract contains all relevant history.
Test eligibility evidence access
For an eligibility laboratory result, establish how the reviewer sees collection time, result version and investigator assessment. If access is restricted, record the limitation and agree a suitable alternative. Avoid routine copying of identifiable clinical records into sponsor systems.
Source access checks
- Confirm named access, permitted functions and expiry arrangements.
- Document the chosen critical data checks and rationale.
- Track unavailable records and unresolved discrepancies to disposition.
Record review limitations
Accept the access method after a test user retrieves the required evidence within the approved permissions. Review whether the method remains suitable after hospital system or workflow changes. Record what was actually reviewed so later readers understand the scope and its limits. If remote access fails, record the stopping point and unseen records so a completed visit status does not conceal unfinished source review.
Frequently asked questions
- Can a site password be shared with a monitor?
- Use authorised individual access arrangements rather than credentials borrowed from site staff.
- Is one SDV percentage suitable for every study?
- Determine scope from the protocol, critical data and risk assessment; a universal percentage is uninformative.