SSArchivingDataManagement object

Study documents must be kept at least (in years)

15

Applicable national legal framework/ Reference

8(2) Regulation 2009 for clinical trials

Additional Information

Sponsor and investigator shall store documents of major significance to the clinical trial for the given time period.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
Feedback