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GCP Recording Standards CRF Completion Data Handling Security Maintenance Audit Requirements by Sponsor/FDA/DOH/IRBs Investigational Product Accountability Management of Study Files/Essential Documents GCP Reporting Standards To Sponsor/IRB/Regulatory Authorities Adverse Events/Serious Adverse Events Interim Reviews Progress Reports Final Reports Monitoring /Audit Reports References /e/ /cache/compo/276-254-1.html .tw .tw * Pattern expired Local vs. global * The European Agency for the Evaluation of Medicinal Products (EMEA) * 證實 * 非類固醇發炎抑制劑比較容易導致胃部與腎臟的副作用，像阿斯匹靈就屬此類，所以藥界發展出副作用比