CASafetyReporting object

Responsible for AE reporting to CA

Sponsor

Sponsor must declare reportable events to

National CA
Relevant EC(s)
All investigators

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

National standard reporting form available

Yes

Standard Reporting Form

Standard forms are posted on the Ministry’s website.

Provision of Annual safety report mandatory

Yes

Annual safety report shall be provided by sponsor to

National CA
Relevant EC(s)

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

The sponsor shall keep detailed records of all adverse events which are reported to him by the principal investigator. These records shall be submitted to the Agency and the ethics committee, if they so request.

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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