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Leitlinie 9 (Vertragliche Rahmenbedingungen)
Die Durchführung einer epidemiologischen Studie setzt definierte rechtliche und finanzielle Rahmenbeding… +
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Les matières autres que celles qui sont du domaine de la loi ont un caractère réglementaire.
Les textes de forme législative intervenus en ces matièr… +
Les traités ou accords régulièrement ratifiés ou approuvés ont, dès leur publication, une autorité supérieure à celle des lois, sous réserve, pour cha… +
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Life-threatening adverse event or life-threatening suspected adverse reaction. An adverse event or suspected adverse reaction is considered “life-thre… +
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MODEL LIST OF ITEMS TO BE CONTAINED IN A CLINICAL TRIAL PROTOCOL… +
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Member State inspections
1. Member States shall appoint inspectors to perform inspections in order to supervise compliance with this Regulation. Th… +
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Metadata
The contextual information required to understand a given data element. Metadata is structured information that describes, explains or otherw… +
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Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training, by Transcelerate Inc.… +
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Miscellaneous Issues
1. Reactions Associated with Active Comparator or Placebo Treatment
It is the sponsor's responsibility to decide whether active c… +
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Modifying or adapting rejected proposals for amendment
25.—(1) Subject to the following provisions of this regulation, if—
(a)the ethics committee … +
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Monitoring
In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and t… +
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Nationale Regelung zum Quelldatenvergleich aus der Ferne (remote SDV)
Auch nach der Aktualisierung der Empfehlungen auf europäischer Ebene gehört Öst… +
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Notification of adverse events
1. The investigator shall report all serious adverse events immediately to the sponsor except for those that the protoc… +
Notification of adverse events
32.—(1) An investigator shall report any serious adverse event which occurs in a subject at a trial site at which he is… +
Notification of serious adverse reactions
1.(a)The sponsor shall ensure that all relevant information about suspected serious unexpected adverse reac… +
Notification of suspected unexpected serious adverse reactions
33.—(1) A sponsor shall ensure that all relevant information about a suspected unexpect… +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 2 +
OTHER OBLIGATIONS OF THE SPONSOR
2. The sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as refe… +
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Paragraph 3 +
OTHER OBLIGATIONS OF THE SPONSOR
3. The documentation mentioned in this Annex shall be kept for a period of at least 10 years after the clinical in… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-001 +
OTHER OBLIGATIONS OF THE SPONSOR
3. The documentation mentioned in this Annex shall be kept for a period of time of at least 10 years after the clini… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-002 +
OTHER OBLIGATIONS OF THE SPONSOR
3. The documentation mentioned in this Annex shall be kept for a period of time of at least 10 years after the clini… +
