临床研究报告.docVIP

2016全新精品资料-全新公文范文-全程指导写作 –独家原创 PAGE1 / NUMPAGES1 临床研究报告 　　篇一：临床研究总结报告结构与内容 　　SOPMW006 Relevant File NO.1 Structure and Content of Clinical Study Summary Report 　　Structure and Content of Clinical Study Summary Report: 　　? Page 1（the contents of each title in page 1 should be listed in separate page） 　　1. Title Page 　　Title page should includes：Generic name of investigation product, drug registration applicant(with seal), research type, research number, study initiation date, study termination date, principal investigator(with signature), study site(with seal), signature of responsible leader of statistics and seal of statistical company, contact information of application, report date, source information retaining site. 　　2. Table of Contents 　　Present the table of contents and corresponding page number of clinical trial summary report. 　　3. Synopsis of Study Report 　　Briefly introduce the accomplished study, and describe the results with meaningful data rather than written description and Pvalue. 　　4. Ethicsrelated Information 　　Declare that this completed clinical trial is conducted in compliance with the ethical principles of medical research of human that have their origin in the Declaration of Helsinki, and that has received independent ethics committee/institutional review board approval, as well as the revision application. The approval document of ethics committee, the clinical trial information which is provided to subjects and the sample of subjects’ informed consent form should be provided. 　　5. Clinical Investigators 　　The clinical trial principal investigator’s name, site, duty in this study and CV (is given in appendix) should be provided, as well as the principal investigators, participants, director of statistical analysis and the writer of clinical study final report. 　　6. Abbreviations 　　The full names of abbreviations in study final report. 　　? Main text 　　1. Introduction 　　Int