CASafetyReporting object
Sponsor
National CA
Relevant EC(s)
All investigators
SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction) in combination studies only
Immediately
Within a max of 7d upon first knowledge (+ 8d for additional information)
Immediately
Within a max of 15d upon first knowledge
No, European standard SUSAR reporting form CIOMS-I recommended
The standardized international form CIOMS-I, used for SUSAR reporting to the Agency, is presented in Attachment 7 of the Rulebook on AR reporting 2011
Yes
National CA
The reporting procedures are specified in Art 43-52 of the Rulebook on AR reporting 2011
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.
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.
AE reporting timelines are in accordance with Directive 2011/20/EC.
