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International Council for Harmonisation E6(R2) addendum: Challenges of implementation
The International Council for Harmonisation (ICH) E6 – good clinical practice (GCP) (R2) addendum – was released in 2016 to encourage implementation of improved approaches for the management of clinical trials. The changes in different sections include new approaches – quality management system, ris...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Medknow Publications & Media Pvt Ltd
2017
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5654214/ https://www.ncbi.nlm.nih.gov/pubmed/29109932 http://dx.doi.org/10.4103/picr.PICR_124_17 |