CASafetyReporting object

Responsible for AE reporting to CA

Sponsor
Principal Investigator (if no sponsor related to study)

Sponsor must declare reportable events to

National CA
EMA Eudravigilance CT Module (EVCTM)
Relevant EC(s)

Reportable AEs

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

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 SUSARs

Within a max of 15d upon first knowledge

National standard reporting form available

No, European standard SUSAR reporting form CIOMS-I recommended

Standard Reporting Form

CIOMS form (if sponsor does not have access to the EudraVigilance)

Reporting format - Options

Online portal
Electronically

Online Safety Reporting Portal

Sponsors shall report SUSARs to EMA´s database, EudraVigilance (IMA has access to information in the database and does not require copies of these reports). If the sponsor does not have access to the EudraVigilance, SUSARs should be reported to IMA electronically on CIOMS forms.

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

Related information is provided on the IMA website in section Home > Licences > Clinical Trials > SUSAR reporting (OR Home > Licences > Clinical Trials > Notification and Reports)

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 29 Regulation no 443/2004
Art 33 Regulation no 433/2004

Investigator shall report SAE to

Sponsor (if AE is fatal, IMA and the EC concerned must also be notified)

Reporting timeline

Immediately (without delay)

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