Human subject protection (Researchers)

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Human Cell Therapy and Gene Therapy Human Trial Protocol Application Data Check List

Human Trial Protocol with the content meeting the following requirements:

The content shall be written in Chinese with the abstract in both Chinese and English included.
The citation and reference shall be noted.
The content shall be in detail and ...

Human Cell Therapy and Gene Therapy Human Trial Protocol Application Data Check List

New Medical Technology (New Medical Technology Combined with New Medical Device) Human Trial Protocol Application Data Check List

Human Trial Protocol with the content meeting the following requirements:

The content shall be written in Chinese with the abstract in both Chinese and English included.
The citation and reference shall be noted.
The content shall be in detail and substantial.
Trial subject
Trial objective
Trial method...

New Medical Technology (New Medical Technology Combined with New Medical Device) Human Trial Protocol Application Data Check List

New Medical Technology (including New Medical Technology Combined with New Medical Device) Human Study Adverse Reaction Report Form

1.Event Date: year month day
2.Report Date: year month day
3.Report to Bureau of Medical Affairs: year month day (filled out by Bureau of Medical Affairs)
4.Reporter
Name: Tel:
Employer:
Occupation: □ medical staff, title...

New Medical Technology (including New Medical Technology Combined with New Medical Device) Human Study Adverse Reaction Report Form

Human subject protection Handbook