Module 5 Presentations

Dose Escalation

• Decisions to escalate not documented, or approval documented after the next dose level was started. • Escalation decisions made by staff not trained and/or delegated to do so. • Data used to make dose escalation decisions not available. • No QC of data used to make dose escalation decisions. • No clear procedure for handling dose escalation trials or no procedure to prevent dose escalation with an inadequate set of data.

31

31

Participant Safety

• Ineligible participants entered into trials, use of waivers. • No confirmation of identity of volunteers (Phase 1). • Failure to test out of hours emergency procedures, participants not supplied with emergency contact details. • Principal Investigator not having access to IRT emergency code break prior to IMP administration and/or unable to unblind without sponsor approval.

32

32

16