Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.2: Difference between revisions
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| | |has_document=Document:GBR MEDDEV 2.7/3 revision 3 May-2015 | ||
| | |module=5 | ||
| | |unit=5.2.4 | ||
| | |scope=MD | ||
| | |doc_part=7.2 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
Β | |tags=TAG-00253-Rep-att ++ TAG-00250-Inv-sme ++ TAG-00017-Spo-die ++ TAG-00046-Ser-sSc ++ TAG-00201-Cli-eSt | ||
|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]] | |||
Β | |comment=Report timelines from investigator to sponsor | ||
|content=7. REPORTING TIMELINES | |||
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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 personnelβs 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 personnelβs 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. | ||
}} | |||
Latest revision as of 13:50, 16 July 2026
| Document information | |
|---|---|
| Reference | GBR MEDDEV 2.7/3 revision 3 May-2015 |
| Validity area | GBR |
| Scope(s) | MD |
| Document name | MEDDEV 2.7/3 revision 3 |
| Version / Revision | May-2015 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS:
SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC. |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 5 β Unit 5.2.4 |
| Scope | MD |
| Document part | 7.2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Reporting timeline, Investigator safety reporting, Sponsor, Serious adverse event, Clinical investigation |
Content
7. REPORTING TIMELINES [...] 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 personnelβs 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.
