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Data Management and Research Informatics Good …

Research Informatics1 data Management data Management andandGood clinical Practice good clinical Practice Patrick Murphy, Research Informatics ,Family Health InternationalResearch Informatics2 What is GCP?What is GCP? good clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve participation of human subjectsResearch Informatics3 Who created GCP?Who created GCP?International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human UsePublished May 1996 Based on practices in the European Union, Japan, United States, Australia, Canada, Nordic countries, and World Health OrganizationResearch Informatics4 How does GCP relate to How does GCP relate to data Management ? data Management ? data Management is not mentioned directly very many principles apply to data Audit TrailDocumentation that allows reconstruction of the course of Source DataAll information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.

Research Informatics 1 Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International

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