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B.16 Publication Policy
Publication policy, if not addressed in a separate agreement.… +
B.4 Trial Design
The scientific integrity of the trial and the reliability of the results from the trial substantially depend on the trial design. A d… +
B.4 Trial Design
[…]
B.4.8 A description of the “stopping rules” or “discontinuation criteria” and “dose adjustment” or “dose interruption” for indivi… +
B.4 Trial Design
[…]
B.4.8 A description of the “stopping rules” or “discontinuation criteria” and “dose adjustment” or “dose interruption” for indivi… +
B.5 Selection of Participants
B.5.1 Participant inclusion criteria.
B.5.2 Participant exclusion criteria.
B.5.3 Mechanism for pre-screening, where … +
B.6 Discontinuation of Trial Intervention and Participant Withdrawal from Trial
The investigator may choose to discontinue the participant from the tr… +
B.6 Discontinuation of Trial Intervention and Participant Withdrawal from Trial
The investigator may choose to discontinue the participant from the tr… +
B.9.4 The type and duration of the follow-up of participants after adverse events and other events such as pregnancies.… +
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Best summarized in this FAQ from the European Commission: https://ec.europa.eu/digital-building-blocks/sites/display/digital/eSignature+FAQ
Simple' e… +
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Bestimmung der zuständigen Bundesoberbehörden und sonstige Bestimmungen
§ 77 Zuständige Bundesoberbehörde,Verordnungsermächtigung
(1) Zuständige Bun… +
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Blinding/Masking
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers… +
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CHAPTER 2
International agreements: disclosure of information
8 Disclosure of information in accordance with international agreements
(1)This section … +
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EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107m (1) +
CHAPTER 4
Supervision of post-authorisation safety studies
Article 107m
1. This Chapter applies to non-interventional post-authorisation safety st… +
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CLASSIFICATION OF DEVICES INTENDED FOR HUMAN USE
Device Classes
SEC. 513. [21 U.S.C. 360c] (a)(1) There are established the following classes of dev… +
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CLASSIFICATION RULES… +
CLASSIFICATION RULES… +
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CLINICAL EVALUATION
[…]
2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member St… +
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CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION… +
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CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC
4. REPORTABLE EVENTS UNDER ANNEX 7 AND ANNEX X OF … +
CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC
5. REPORT BY WHOM.
Reportable events have to be re… +
