![]() ![]() Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. ICH E6: Good Clinical Practice: Consolidated Guidance (R2- Integrated Addendum) (PDF - 484 KB) ![]() ICH E5 Questions and Answers (PDF - 48KB) This International Conference on Harmonization (ICH) document makes recommendations for strategies to permit clinical data collected in one region to be used to support drug and biologic registrations in another region while allowing for the influence of ethnic factors. ![]() ICH E5: Ethnic Factors in the Acceptability of Foreign Clinical Data (PDF - 89KB) ICH E3 Questions and Answers (PDF - 141KB) The guideline is intended to assist sponsors in the development of a report that is complete, free from ambiguity, well organized and easy to review. This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects. ICH E3: Guideline for Industry Structure and Content of Clinical Study Reports (PDF - 240KB) ![]()
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