Nel pieno delle danze: monitoraggio
Enrico Bergonzani, CRA Milano – 14 Giugno 2018
ICH – GCP definition
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1.38 Monitoraggio
La supervisione dell’andamento di uno studio clinico per garantire che questo venga effettuato, registrato e relazionato in
osservanza del protocollo, delle Procedure Operative Standard (SOP), della GCP e delle disposizioni normative applicabili
ICH – GCP definition
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ICH – GCP definition
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– “The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan)”
– “The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials.”
– “The sponsor may choose on-site monitoring, a combination of on-site
and centralized monitoring, or, where justified, centralized monitoring”
Conceptual areas of activities
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Monitoring patient safety – HIGH PRIORITY
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– Consent Documents – Eligibility Criteria
– Adverse Events / Serious adverse events – Laboratory Abnormalities
– Efficacy and safety Parameters / Discontinuation criteria
– Protocol Adherence / Deviations
Practical areas of activities
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Source data verification
Source data review
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Source Data Review vs Source Data Verification
Case study: Checking a ECG value
SDR is reviewing the source to check that the site
– performed the ECG as and when required by the protocol,
– the ECG report was signed and dated by the PI the delegated person, – and if it was abnormal and clinically significant whether an AE was
documented.
SDV is checking if the ECG value was correctly entered in the eCRF.
Investigational Product management and accountability
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The monitor must verify effectiveness/documentation of – IP receipt and supply
– IP storage
– IP handling and preparation – IP dispensation
– Dosing compliance – IP return to the site – IP destruction
Through document review and IP physical checks
In accordance with the protocol, GCP, and applicable laws.
Investigator Site File Vs Trial Master File
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The CRA must verify the investigator site file is complete and up to date.
– Site Visit Log
– Site Responsibility/Delegation Log – Site Training Log
– Subject Identification Log – Informed Consent Log – IP Logs
– Subject Enrollment Log
Informed Consent forms, Regulatory and Ethics submissions and approvals, IB, Curriculum vitae, SUSAR, etc.
CROSS CHECK BETWEEN ISF AND TMF
After the monitoring visit
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CRA's approach: Corrective Action / Preventive Action
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CRA's approach: Corrective Action / Preventive Action
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Evitare l’approccio “reattivo”
Schema fisso:
1. Problema individuato 2. Correzione richiesta
3. Errore e risoluzione documentati
4. Re-training effettuato come azione preventiva
Ciascun evento trattato singolarmente
Proactivity vs Reactivity
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• Effective and continuous communication:
- with the clinical site - with the project team
• See beyond the data / issue
• Think critic:
- What does that means?
- What risks / consequences? Site level or study level?
• Be Big-picture minded
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