Module 5 Presentations

Sponsor Oversight

• Lack of evidence of sponsor oversight in relation to regulatory approvals and green light, Pharmacovigilance and SUSAR reporting, monitoring etc. • Lack of evidence of oversight of vendors from selection, through to conduct.

Medical/PI Oversight

• No evidence of PI/Medic making medical decision (i.e. eligibility, dosing/dose changes, AE/SAE assessments, medical results reviews etc.).

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Delegation of Duties

• Activities delegated to trial team without appropriate prior training. • No delegation log used to document delegated activities or log incorrectly completed (i.e. specific activities not identified, unclear when staff were actually delegated activities).

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