Pharmacovigilance
A key provision of the services of I.D.E.A. Ltd. is compliance on behalf of the sponsor with article 16 of the EU Directive, EudraVigilance notification and reporting, compliance with article 2 of the EU Directive, reporting of seriousness and causality of adverse events (AEs) and in reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs).
The Investigator is obliged to report all Serious Adverse Events (SAEs) immediately to the sponsor/legal representative, who must maintain records of all reported AEs, expedited reports of serious unexpected AEs and annual safety reports to CAs and ECs.
CIOMS form
To download an electronic copy of a CIOMS form please click here [ PDF File ]
Further details
All serious and unexpected AEs having a suspected causal relationship to the IMP test or reference, are referred to as SUSARs. They are subject to expedited reporting within a defined timeframe. A standard tool for expedited AE reporting is the CIOMS form. As soon as the EudraVigilance database is available, electronic reporting will be the expected method for expedited reporting of SUSARs.
Furthermore, the sponsor/legal representative should communicate any findings that could adversely affect the safety of study subjects to all Investigators concerned.