The data supporting clinical trial phase planning is usually present but rarely assembled into a decision. Cost pressure and quality expectations on phase planning are rising at the same time. Participants come from operational and oversight roles, and both perspectives on this part of health and pharmaceutical services are used deliberately. Most organisations already have a policy on clinical trial phase planning; far fewer can show it working. Cases are chosen to expose the trade-offs in the health and pharmaceutical services discipline rather than to illustrate ideal conditions. The most reliable predictor of sound phase planning is whether anyone reviews it when nothing has gone wrong. The course leaves participants able to diagnose weaknesses in clinical trial phase planning before they become incidents. Participants leave with a method for phase planning, not a set of opinions about it. The course ends by identifying what the participant will stop doing to make this strand of health and pharmaceutical services sustainable.
Expected Learning Outcomes
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Plan continuity of clinical trial phase planning during surge, outbreak and emergency.
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Translate policy on phase planning into procedures that hold up under day-to-day pressure.
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Apply regulatory and licensing requirements governing clinical trial phase planning.
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Prepare the documented evidence accreditation assessors expect on phase planning.
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Assess and control infection risk associated with clinical trial phase planning.
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Agree the first three actions on phase planning that will be taken on returning to work.
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Prepare a short, evidence-based briefing on clinical trial phase planning for senior management.
Who Should Attend
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Risk managers assessing the exposure created by clinical trial phase planning.
