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2. Paragraph 1 shall not apply if one of the following applies:
(a) the data subject has given explicit consent to the processing of those personal… +
2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those clinical trials on inca… +
2. The minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity.
3. If during a clinical tr… +
2. Where the conclusion of the reporting Member State is that the substantial modification is acceptable or acceptable subject to compliance with sp… +
2. Without prejudice to Directive 95/46/EC, the sponsor may ask the subject or, where the subject is not able to give informed consent, his or her l… +
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DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2 +
2. Anwendungsbeobachtungen (AWB)
2.2. Nationale Anzeigeplicht nach § 67 Absatz 6 AMG
[...]
Unter die Anzeigeplicht nach § 67 Absatz 6 AMG fällt ebenf… +
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2.1 - Ende +
2. Anwendungsbeobachtungen (AWB)
2.2.1. Anzeigeinhalte gegenüber den Bundesoberbehörden
[...]
Zusätzlich zum Anzeigeformular sind weitere Unterlagen … +
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.3 +
2. Anwendungsbeobachtungen (AWB)
2.3. Ausnahmen von der Anzeigepflicht nach § 67 Absatz 6 AMG
Folgende Studientypen fallen nicht unter den Begriff ei… +
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.5 +
2. Anwendungsbeobachtungen (AWB)
2.7.5. Interessenkonflikte, Ethik
[...]
Es sollte sichergestellt sein, dass vor Durchführung einer Anwendungsbeobach… +
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2. Clinical Investigation Plan
[….]
Description of procedures and details of data to record and report serious adverse events and adverse device rela… +
2. Clinical Investigation Plan
[….]
Description of procedures and details of data to record and report serious adverse events and adverse device rela… +
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FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-001 +
2. DECLARATION DES FAITS NOUVEAUX ET MESURES URGENTES DE SECURITE
Bien que le RDM ne le prévoie pas, il est demandé pour les RIPH1 portant sur un DM s… +
FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-002 +
2. DECLARATION DES FAITS NOUVEAUX ET MESURES URGENTES DE SECURITE
Bien que le RDM ne le prévoie pas, il est demandé pour les RIPH1 portant sur un DM s… +
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2. INVESTIGATOR
[...]
2.13 Reports
Upon completion of the trial, the investigator, where applicable, should inform the institution. The investigator/i… +
2. INVESTIGATOR
[...]
2.2 Informed Consent Considerations
[...]
2.2.1 Informed consent may be obtained remotely, where appropriate. When informed cons… +
2. INVESTIGATOR
[...]
2.6 Premature Termination or Suspension of a Trial
2.6.1 If the trial is prematurely terminated or suspended for any reason, th… +
2. INVESTIGATOR
2.1 Qualifications and Training
2.1.1 The investigator(s) should be qualified by education, training and experience to assume respon… +
2. Other Observations
There are situations in addition to single case reports of "serious" adverse events or reactions that may necessitate rapid com… +
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2. Paragraph 1 shall not apply if one of the following applies:
(a) the data subject has given explicit consent to the processing of those personal d… +
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2. THE PROTOCOL
The clinical trial should be carried out in accordance with a written protocol agreed upon and signed by the investigator and the spon… +
