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A favourable vendor assessment does not provide identical assurance for every later version of a service. Explain which changes could invalidate the assumptions used during review. Reassessment can then respond to relevant events rather than waiting only for the next scheduled audit.
Scope of the decision
Relevant changes may affect location, a key process, a subcontractor, data flow or responsibility arrangements. Not every change requires a full new audit. First assess its effect on the service actually used and the study risk, then request targeted evidence or a suitable additional review where needed.
Worked review
For example, a central laboratory transfers previously reviewed activities to another facility. The sponsor examines the new facility’s role and sample handover rather than automatically accepting the old report. It explains implications for reliable results and connects the continuation decision to evidence and explicit outstanding conditions.
Practical checks
- Define change types that could affect the assumptions behind qualification.
- Match each notification to the service scope and relevant study risks.
- Record the basis for continuation, targeted review or a justified restriction.
Acceptance and limits
Acceptance means understanding which parts of the earlier assessment remain valid and how new gaps are managed. Receiving a notification does not demonstrate that impact was reviewed. Communication arrangements should help important changes reach the study team promptly.
Frequently asked questions
- Does every staff change require another audit?
- No. Assess the role’s criticality and its effect on service proportionately.
- Does a new contract replace the previous audit?
- Not by itself. Contracts define responsibilities; the suitability of supporting process evidence still needs consideration.