Key guidance, flowcharts, and resources to support researchers through the clinical research pathway. GL004 Guidance notes for risk assessment completion v3.0 This guidance applies to clinical studies involving advanced therapy investigational medicinal products (ATIMPs), gene therapies, or genetically modified organisms (GMOs) that require approval from the Advanced Therapy and Genetic Modification Safety Committee for Research. Document GL004 Guidance Notes v3.0 (824.05 KB / 0) GL007 Electronic Filing - Naming Convention and Quality Control v2.0 Document GL007 Guidance v2.0 (1.01 MB / 0) GL008 Guidance on clinical evaluation of medical devices and clinical performance of in vitro diagnostic medical devices v1.0 Document GL008 Guidance v1.0 (1.09 MB / 0) This article was published on 2024-11-07
