CASafetyReporting object

Responsible for AE reporting to CA

Sponsor

Sponsor must declare reportable events to

Competent Authority
Relevant EC(s)
All investigators

Reportable AEs

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

SAE /SADE must be reported

Immediately
(Reportable events must be fully recorded)

National standard reporting form available

Yes

Standard Reporting Form

Standard AE reporting form is available (in Serbian and cyrillic script) on the ALIMS website in section Regulativa » Medicinska sredstva» Obrasci (“Obrasci za prijavljivanje neželjenih reakcija na medicinsko sredstvo”)

Provision of Annual safety report mandatory

Yes

Annual safety report shall be provided by sponsor to

National CA

Guidance on AE reporting procedure

An Annual safety report on all adverse reactions must be submitted by the sponsor to the national CA. Attachment 6 of the Rulebook Rulebook AR reporting 2011 prescribes in detail the required contents of the safety report.

Applicable national legal framework/ Reference

Art 92 Law on MP & MD 2010
Rulebook AR reporting 2011

Additional Information

Sponsor is required to report quarterly to the national CA and the EC about the conduct of the clinical trial, pursuant to Art 92 Law on MP & MD 2010. The tri-monthly report encompasses the number of subjects involved per site, the occurrence of adverse reactions as well as other relevant data related to the implementation of the clinical trial.

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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