Clinical Quality (GCP)
Sponsor oversight, subject protection, and the credibility of trial data.
Sponsor oversight and subject protection are the core of Good Clinical Practice. Inadequate oversight of CROs and delegated activities, and failures in informed-consent control, are recurring inspection findings that can invalidate trial data outright — the highest-stakes outcome in the clinical space.
The observable evidence a practitioner — or an inspector — would expect at each maturity level. Drawn from the assessment questions themselves.
How is sponsor oversight of clinical trials and vendors managed?
No formal sponsor oversight of CROs or delegated activities
Oversight SOPs exist; monitoring is largely on-site source data verification
Risk-based monitoring around critical-to-quality factors per ICH E6(R3)
Integrated oversight with key risk indicators, centralised monitoring, and documented vendor governance
Predictive quality oversight: centralised analytics and KRIs drive real-time intervention; vendor governance benchmarked across the portfolio
How is informed consent controlled across trial sites?
Consent versions managed locally; reconciliation is ad hoc
Central consent templates, but site version control is inconsistent
Version-controlled consent reconciled against IRB/IEC-approved versions at monitoring
eConsent with audit trails and real-time version enforcement
eConsent with real-time version enforcement, automated reconciliation, and analytics on consent integrity across the portfolio
- ›Inadequate sponsor oversight of CROs or delegated activities — no documented vendor governance.
- ›Informed-consent version-control failures; consent not reconciled to the IRB/IEC-approved version.
- ›Protocol deviations not captured, assessed for impact, or reported.
- ›Monitoring not risk-based around the critical-to-quality factors of ICH E6(R3).