CASafetyReporting object
Sponsor
National CA
CA(s) of EU&EFTA Member States concerned
EMA Eudravigilance CT Module (EVCTM)
Relevant EC(s)
All participating sites
SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)
Within a max of 7d upon first knowledge (+ 8d for additional information)
Within a max of 15d upon first knowledge
Yes
National CA
CA(s) of EU&EFTA Member States concerned
Relevant EC(s)
7z, 37aa Pharmaceutical Law 2001 (en)/ Dz.U. 2008 nr 45 poz. 271 (pl)
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.