View source for Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.1

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{{:Document:GBR MEDDEV 2.7/3 revision 3 May-2015}}

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Scope
| MD
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! Document part
| 7.1
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Contributors
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! Tags (EN)
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! Tags (original language)
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! Tags (FR)
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! Comment
| Reporting timelines for SAEs to NCAs
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== Content ==
7. REPORTING TIMELINES
7.1 Report by sponsor to NCAs.
The sponsor must report to the NCAs where the clinical investigation has commenced:
- for all reportable events as described in section 4 which indicate an imminent risk of death, serious injury, or serious illness and that requires prompt remedial action for other patients/subjects, users or other persons or a new finding to it: immediately, but not later than 2 calendar days after awareness by sponsor of a new reportable event or of new information in relation with an already reported event.
- any other reportable events as described in section 4 or a new finding/update to it: immediately, but not later than 7 calendar days following the date of awareness by the sponsor of the new reportable event or of new information in relation with an already reported event.
[...]