Guidelines for Writing the Basic Content of Clinical Research Reports on Vaccines
Request Guidelines for Writing the Basic Content of Clinical Research Reports on Vaccines
  • Local Title:疫苗临床研究报告基本内容书写指南
  • Country/Region:Chinese Mainland
  • Competent Authority: Former China Food and Drug Administration (CFDA)
  • Type:Guideline
  • Status:In force
  • Release Date:2005-10-12
  • Implementation Date:2005-10-12
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ZH Official 疫苗临床研究报告基本内容书写指南 Download
Summary

The Guidelines for Writing the Basic Content of Clinical Research Reports on Vaccines was issued on Oct.12, 2005. It is formulated to strengthen guidance on clinical research on vaccine biological products and further standardize the format of clinical research reports, which includes:

1. Phase I Clinical Trial

2. Report Format for Phase II/III Clinical Trials

3. Accessories