Property:RefPreview
From GxPlex
Auto-derived 200-character preview of this reference's content, used in Document pages' References list.
D
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.6 +
2.7.6. Berichte und Archivierung
Ergebnisse von Anwendungsbeobachtungen sollten nach wissenschaftlichen Kriterien publiziert werden. Es wird empfohle… +
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.7 +
2.7.7. Vergütung und Honorierung
Die Beteiligung an einer Anwendungsbeobachtung ist in der Regel eine ärztliche Tätigkeit. Bei Arzneimitteln, die nic… +
I
2.8 Informed Consent of Trial Participants… +
2.8.12 Where a minor is to be included as a participant, age-appropriate assent information should be provided and discussed with the minor as part of… +
2.8.13 When a clinical trial includes participants who may only be enrolled in the trial with the consent of the participant’s legally acceptable repr… +
2.8.8 In emergency situations, when prior consent of the participant is not possible, the consent of the participant’s legally acceptable representati… +
2.8.9 If a participant or the legally acceptable representative is unable to read, an impartial witness should be present (remotely or in-person) duri… +
2.9 End of Participation in a Clinical Trial
[...]
2.9.3 Where relevant, the investigator should inform the participant about the trial results and tr… +
2.9 End of Participation in a Clinical Trial
2.9.1 When a participant decides to stop treatment with the investigational product or withdraw from a tr… +
E
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.9 +
2.9. Recruitment and consent
Points to consider:
• Recruitment strategies.
• Volunteer database.
• Collection and verification of the trial participan… +
W
23. [...] After the end of the research, the researchers must submit a final report to the committee containing a summary of the findings and conclusi… +
29. When a potential research participant who is incapable of giving free and informed consent is able to give assent to decisions about participation… +
G
29A. (1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of -
(a) the conditions and principles … +
E
3. Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participati… +
3. Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participati… +
3. Manufacturers shall report any serious incident as referred to in point (a) of paragraph 1 immediately after they have established the causal rel… +
3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give… +
3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 3 – 5 +
3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give… +
3. The sponsor shall also report to the Member States in which the clinical investigation is being conducted any event referred to in paragraph 2 of… +
