Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.2 - Revision history

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	~~{{:Document:GBR MEDDEV 2.7/3 revision 3 May-2015}}~~		\|tags_display=[[Glossary:TAG-00253-Rep-att\|Reporting timeline]], [[Glossary:TAG-00250-Inv-sme\|Investigator safety reporting]], [[Glossary:TAG-00017-Spo-die\|Sponsor]], [[Glossary:TAG-00046-Ser-sSc\|Serious adverse event]], [[Glossary:TAG-00201-Cli-eSt\|Clinical investigation]]
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	\| [[Glossary:TAG-00253-Rep-att\|Reporting timeline]], [[Glossary:TAG-00250-Inv-sme\|Investigator safety reporting]], [[Glossary:TAG-00017-Spo-die\|Sponsor]], [[Glossary:TAG-00046-Ser-sSc\|Serious adverse event]], [[Glossary:TAG-00201-Cli-eSt\|Clinical investigation]]
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	\| Report timelines from investigator to sponsor
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	~~== Content =~~=
	7. REPORTING TIMELINES
	[...]		[...]
	7.2 Report by the investigator to the sponsor		7.2 Report by the investigator to the sponsor
	The sponsor shall implement and maintain a system to ensure that the reporting of the reportable events as defined under chapter 4 will be provided by the investigator to the sponsor immediately, but not later than 3 calendar days after investigational site study personnel’s awareness of the event.		The sponsor shall implement and maintain a system to ensure that the reporting of the reportable events as defined under chapter 4 will be provided by the investigator to the sponsor immediately, but not later than 3 calendar days after investigational site study personnel’s awareness of the event.
	In some cases, a different periodicity or different modalities 12 may be agreed by the participating NCAs according to the investigational design and to the pathology under clinical investigation. This would allow adequate provision for clinical investigations (e.g. palliative oncology), in which SAE frequency is expected to be high due to progression of the disease. This needs to be agreed between the sponsor and relevant NCAs.		In some cases, a different periodicity or different modalities 12 may be agreed by the participating NCAs according to the investigational design and to the pathology under clinical investigation. This would allow adequate provision for clinical investigations (e.g. palliative oncology), in which SAE frequency is expected to be high due to progression of the disease. This needs to be agreed between the sponsor and relevant NCAs.
			}}

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

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	}}		}}

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

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	== ~~Text~~ ==		== Content ==
	7. REPORTING TIMELINES		7. REPORTING TIMELINES
	[...]		[...]