CASafetyReporting object

Responsible for AE reporting to CA


Sponsor must declare reportable events to

National CA
CA(s) of EU&EFTA Member States concerned
EMA Eudravigilance CT Module (EVCTM)
Relevant EC(s)
All participating sites

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

Provision of Annual safety report mandatory


Annual safety report shall be provided by sponsor to

National CA
CA(s) of EU&EFTA Member States concerned
Relevant EC(s)

Applicable national legal framework/ Reference

7z, 37aa Pharmaceutical Law 2001 (en)/ Dz.U. 2008 nr 45 poz. 271 (pl)

Additional Information

The sponsor and investigation are liable for any damage caused in connection with the clinical trial conduct, pursuant to Art 37j Pharmaceutical Law 2001.

The sponsor is storing the documentation of the trial SAE and SUSARs according to Good Clinical Practice and is providing the documentation to the EU and EFTA countries if required.

The President of the Office (URPL) is also collecting the information related to reported AE of medicinal products and is analysing and processing the reports, including further reporting to EudraVigilance and WHO.