The table below provides an overview of all notifications with corresponding 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 15 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 |