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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 re… +
7. REPORTING TIMELINES
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7.2 Report by the investigator to the sponsor
The sponsor shall implement and maintain a system to ensure that the report… +
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7.1 Handling of and recording adverse events
[…]
Consideration should be given to establishing a special committee to monitor adverse events (see also… +
7.1 Handling of and recording adverse events
In accordance with Sections 4.1 and 4.3 of these guidelines, the investigator must ensure the safety of t… +
7.1 Handling of and recording adverse events
[…]
The occurrence of adverse events must be monitored carefully and recorded in detail during the course… +
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7.11 Auditing
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An audit can be used
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7.2 Reporting
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The investigator
The investigator has to report serious adverse events to the sponsor immediately and to the drug regulatory authori… +
7.2 Reporting
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The sponsor
During the trial, the sponsor is responsible for reporting and trial-related adverse events or reactions associated with… +
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7.4 Trial processes should be operationally feasible and avoid unnecessary complexity, procedures and data collection. Trial processes should support … +
7.4.3 Device deficiencies
[…]… +
7.4.3 Device deficiencies
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7.5.1 Amendments
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7.5.3 Source documents
[…]… +
7.8.1 Traceability of documents and data
[….]… +
7.9 Investigational device accountability
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7.—(1) Subject to paragraph (3), the Authority may, by a notice in writing, recognise a committee as an ethics committee for the purposes of these Reg… +
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EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001 +
8 Reporting timelines
8.1 Report by sponsor to NCAs.
The sponsor must report to all NCAs where the clinical investigation is authorised to start:
• Fo… +
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002 +
8 Reporting timelines
8.1 Report by sponsor to NCAs.
The sponsor must report to all NCAs where the clinical investigation is authorised to start:
• Fo… +
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001 +
8 Reporting timelines
[...]
8.2 Report by the investigator to the sponsor
The sponsor shall implement and maintain a system to ensure that the reporti… +
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002 +
8 Reporting timelines
[...]
8.2 Report by the investigator to the sponsor
The sponsor shall implement and maintain a system to ensure that the reporti… +
