ECSafetyReporting object

Reportable AEs

SAE (Serious Adverse Event)
SADE (Serious Adverse Device Effect)

Investigator shall report SAE to

Sponsor

Reporting timeline

Immediately (followed by a detailed, written report)

Responsible for AE reporting to relevant EC(s)

Sponsor

SAE/SADE must be reported

Within a max of 7 d upon first knowledge (+8d for additional information) for events being life-threatening or leading to death
Within a max of 15d upon first knowledge

Sponsor is obliged to notify all investigators of SAE/ SADE occurrence

Yes

National Standard Reporting form available

Yes

Standard Reporting Form

Standard forms are posted on the Ministry’s website.

Guidance on AE reporting procedure available

Yes

Guidance on AE reporting procedure

Please refer to the Guideline for Good Clinical Practice 2014 for further details of AE reporting.

National legal framework in place

Yes

Applicable national legal framework/ Reference

Regulation On Medical Device Clinical Trials 2014

Additional Information

ad Annual Safety Report: The sponsor shall send a list of all serious adverse device effects observed, containing also information on safety of the subjects, to the ethics committee and the Agency, once every year. When the Agency may so deem necessary or in investigations with short periods, the Agency may also request the report earlier (Regulation On Medical Device Clinical Trials 2014).

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
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