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Risk log assessment and follow up plan

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This is critical to understand and maintain/improve performance throughout the project lifecycle.  With the pilot study completed and full study implementation in place it is possible for each center to undertake a risk assessment during full study phase considering risk impact, action and outcome.  This assessment will continue throughout the study and is a primary responsibility of the recruitment center’s Project Manager with guidance from the PI, who will assess the minor, medium and major project risks and initiate action/mitigation as needed.  The template outlines possible risk descriptors for consideration across centers in a report that should be conducted on a monthly basis. This will be adapted through the project life cycle in conjunction with detailed process evaluation but should be completed on, at least, a quarterly basis.

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