Overview of notifications

The table below provides an overview of all notifications with corresponding definitions and timelines.

Overview of notifications with definitions and timelines
Notification Definition Timeline
Date start of clinical trial First act of recruitment of a potential subject for a specific clinical trial, unless defined differently in the protocl < 15 days of this date
Date first visit of first subject < 15 days of this date
Date end of recruitment < 15 days of this date
Restart of recruitment < 15 days of this date
Date end of clinical trial in MSc The last visit of the last subject, or at a later point in time as defined in the protocol < 15 days of this date
Date end of clinical trial in all MSc The last visit of the last subject, or at a later point in time as defined in the protocol < 15 days of this date
Date end of clinical trial in all MSc and in all 3rd countries The last visit of the last subject, or at a later point in time as defined in the protocol < 15 days of this date
Temporary halt of clinical trial in all MSc for reasons not affecting benefit-risk balance An interruption not provided in the protocol of the conduct of a clinical tiral by the sponsor with the intention of the sponsor to resume it < 15 days (include the reason)
Resume clinical trial after temporary halt (as referred to in previous row) < 15 days from the restart in all MSc
Early termination of clinical trial for reasons not affecting benefit-risk balance The premature end of a clinical trial due to any reason before the conditions specified in the protocol are complied with < 15 days (include the reason and when appropriate the follow-up measures for the subjects)
Temporary halt or early termination for reasons of safety An interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of the sponsor to resume it < 15 days (include the reason and specify the follow-up measures)
Serious breaches A breach likely to affect to a signifcant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial Without undue delay but not later than 7 days of becoming aware of the breach
Unexpected events, not being SUSARs, which affect the benefit-risk balance Without undue delay but not later than 7 days of become aware of the event
Urgent safety measures Withou undue delay but not later than 7 days from the date the measures have been taken