Revision of the Initial Review Application for New Cases

Attachment SOP005-03 New Case Initial Review Application Form Item 7 Trial Item Introduction Revision

• Before Revision
  • Drugs (format as Appendix 1)
  • Vaccines (format as Appendix 2)
  • Genetic Research (format as Appendix 3)
  • Medical Devices (format as Appendix 4)
  • Medical Technology (format as Appendix 5)
  • Other

• After Revision
  • Drugs (format as Appendix 1)
  • Vaccines (format as Appendix 2)
  • Genetic Research (format as Appendix 3)
  • Medical Devices (format as Appendix 4)
  • Medical Technology (format as Appendix 5)
  • Other_________________________

Allows the research team to fill in themselves, e.g., “instrument experiments of conventional treatment”, etc.

This form was officially used on November 1, 110.