Collection, storage and use of biological samples and related data in paediatric trials

Published by ECRIN

Clinical Trials Toolkit

PedCRIN tool: A checklist developed to help researchers, sponsors, and other affiliated personnel verify that all key aspects required to properly manage samples and related data in the context of paediatric trials are taken into consideration

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EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

Published by European Commission (EC)ECRIN

Clinical Trials Toolkit

Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level. The Annex also includes guidance on ordering, shipping, and returning clinical supplies, which are at the interface with, and complementary to, guidelines on Good Clinical Practice.

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GCLP (Good clinical laboratory practice) Guidance

Published by ECRINThe Asia Pacific Observatory on Health Systems and Policies (APO)

Clinical Trials Toolkit

This guidance identifies systems required and procedures to be followed within an organization conducting analysis of samples from clinical trials in compliance with the requirements of Good Clinical Practice (GCP). It thus provides sponsors, laboratory management, project managers, clinical research associates (CRAs) and quality assurance personnel with the framework for a quality system in analysis of clinical trial samples, ensuring GCP compliance overall of processes and results.

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