ECSafetyReporting object

Reportable AEs

SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)

Investigator shall report SAE to

Sponsor

Reporting timeline

Immediately (without delay)

Responsible for AE reporting to relevant EC(s)

Sponsor

SUSAR being life-thereatening or leading to death must be reported

Within a max of 7d upon first knowledge (+ 8d for additional information)

All other SUSAR must be reported

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.

Provision of Annual safety report mandatory

Yes

Guidance on AE reporting procedure available

Yes

Guidance on AE reporting procedure

A comprehensive guideline is available (Guideline Regarding Collection, Verification, and Submission of the Reports of Adverse Events/Reactions Occurring in Clinical Trials of Medicinal and Biological Products 2014).

National legal framework in place

Yes

Applicable national legal framework/ Reference

Regulation on Clinical Trials of Medicinal and Biological Products 2014

Additional Information

Once a year, the sponsor will provide the ethics committee and the Agency with a listing of all suspected serious adverse reactions occurring during the trial, including information relevant to subjects’ safety, using the interim report form provided in the relevant guidelines to be issued by the Agency. In short-term studies or where necessary, the Agency may request a report earlier (Regulation on Clinical Trials of Medicinal and Biological Products 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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