Hideivp trial
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Hideivp trial
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Web• General Considerations for Clinical Trials, (ICH E8) CPMP/ICH/291/95. • EUDRALEX- Volume 10 – Clinical trials. In particular: Chapter I: Application and Application Form and Chapter II: Monitoring and Pharmacovigilance. 2. SCOPE This guideline applies to all new chemical and biological investigational medicinal products except Web31 March1 2024. 2 EMA/15975/2016 3 Good Clinical Practice Inspectors Working Group (GCP IWG) 4 Guideline on GCP compliance in relation to trial master file 5 (paper and/or electronic) for content, management, 6 . archiving, audit and inspection of clinical trials 7 . Adopted by GCP Inspectors Working Group (GCP IWG) 30 January 2024
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