The pilot project of The Last Half of FY2014 has ended. Thank you very much for your cooperation.
- Request for Electronic Clinical Study Data for Pilot Project
- Outline of execution plan of the pilot project in The Last Half of FY 2014 (draft)
- Summary Report
*This is a supplementary explanation about the utilization of the electronic clinical study data for the exploratory examination of the conformity inspection process in the pilot project during the last half of FY2014.
In this pilot project, it has been our plan to understand the structures and contents of the submitted data and related information by inspectors.
We do not intend to verify the conformity of the submitted data itself. The conformity inspection will not be carried out by our inspectors.