Module232025

12/05/2025

Protocol: Eligibility Criteria

The Organisation for Professionals in Regulatory Affairs

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• Use sparse sampling techniques: • Blood taking should be coordinated and limited. Minimise volume drawn and number of samples • Use local advice, local ethics committee to understand what is allowed • Lab capabilities: • can the labs deal with small volumes. Can the sensitivity of assay be improved • do results/normal ranges need adjusting for age • Often, PK analyses can be run from blood samples taken for other reasons • Reduce distress • Topic anesthetic (protocol option) • Paediatrictubes, butterfly needles, cannulas Protocol: Lab tests

The Organisation for Professionals in Regulatory Affairs

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