According to the announcement about Accepting the Medical Device Oversea Clinical Trial Data Technical Guideline, subjects and technical review differences might affect the acceptance of the oversea clinical trial data. And how will the clinical trial condition differences affect the Oversea Clinical Trial Data Acceptance.
What are the clinical trial condition differences?
It includes medical environment, medical facilities, researcher ability( learning curve), treatment concept, criteria differences and etc.
How will the clinical trial condition differences affect the Oversea Clinical Trial Data Acceptance?
Some clinical trial condition differences listed above will have a significant impact on the clinical trial result. For example, if the treatment concept and criteria is different, clinical practice may not accord with CFDA relevant clinical operation guideline. In addition, differences in the level of medical facilities and researchers will have impact on clinical trial data. If the medical devices require high maneuverability, the ability of the researcher to use the devices might directly influence the the clinical trial result.
- Accept the Medical Device Oversea Clinical Trial Data Technical Guideline
- The Oversea Clinical Trial Data Submission Condition and Acceptance Requirements
- Technical Review Differences for The Oversea Clinical Trial Data Acceptance
- How Will the Subjects Difference Affect the Oversea Clinical Trial Data Acceptance