Rating: 4.5 / 5 (6479 votes)
Downloads: 66770
>>>CLICK HERE TO DOWNLOAD<<<
Read together with questions and answers. All guidelines; quality guidelines; safety guidelines; efficacy guidelines; multidisciplinary guidelines; index of guidelines; ich standards. Reflection papers. E3 current step 4version dated 30 november 1995 this guideline has been developed by the appropriate ich expert working group and has been subject to consultation by the regulatory parties, in accordance with the ich process. The regulatory authority specific additions will consist of modules to be considered as appendices, available upon request according to regional regulatory requirements. Ich e3: guideline for industry structure and content of clinical study reports ( pdf - 240kb) Process of harmonisation; public consultations; guideline implementation; ich guidelines. Meddra; ctd; electronic standards ( estri) other work products. Acceptable to all regulatory authorities of the ich regions.
Guidance for industry1 e3 structure and content of clinical study reports — questions and answers ( r1) this guidance represents the food and drug administration’ s ( fda’ s) current thinking on this. The clinical study report described in this guideline is an " integrated" full report of an. Ich harmonisation activities. Ich e3 structure and content of clinical study reports - scientific guideline share table of contents current effective version this document aims to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the ich regions.
留言列表
