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3.45 serious adverse event SAE
[…]… +
3.5 Financing
The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator/institution.… +
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EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.2 +
3.5.2. Superseded documents
During a document’s development (e.g. clinical trial protocol development and release), the sponsor’s/CRO’s procedures may… +
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.3 +
3.5.3. Correspondence
Relevant correspondence that is necessary for reconstruction of key trial conduct activities and decisions should be retained. T… +
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3.6 Agreements
3.6.1 Agreements made by the sponsor with the investigator/institution, service providers and any other parties (e.g., independent data… +
3.9 Sponsor Oversight
[...]
3.9.7 The sponsor may consider establishing an IDMC to assess the progress of a clinical trial, including the safety data … +
3.9.3 The sponsor should determine necessary trial-specific criteria for classifying protocol deviations as important. Important protocol deviations a… +
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31. The physician or other researcher must fully inform potential participants which aspects of their care are related to the research. The refusal of… +
36. Researchers, authors, sponsors, editors, and publishers all have ethical obligations with regard to the publication and dissemination of the resul… +
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4. A clinical investigation as referred to in paragraph 1 may be conducted only where all of the following conditions are met:
(a) the clinical inv… +
4. For the purpose of this Article, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of th… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 4 – 5 +
4. If a study is conducted in more than one Member State, the sponsor shall notify all Member States in which that performance study was conducted o… +
4. If an investigation is conducted in more than one Member State, the sponsor shall notify all Member States in which that clinical investigation w… +
4. In the case of a clinical investigation for which the sponsor has used the single application referred to in Article 78, the sponsor shall report… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 4 +
4. In the case of a performance study for which the sponsor has used the single application referred to in Article 74, the sponsor shall report any … +
4. Where the reporting Member State, taking into account considerations expressed by the other Member States concerned, finds that the application d… +
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 4 +
4. Clarification on reporting requirements
• Serious breaches which occurred outside the EU/EEA while the application for a clinical trial authorisati… +
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4. DATA GOVERNANCE – INVESTIGATOR AND SPONSOR… +
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EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4. +
4. Informed consent of trial subjects
[…]
Documentation in the source data of the process of obtaining the initial informed consent and subsequent con… +
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4. „sonstige klinische Prüfung“ eines Produktes eine klinische Prüfung, die
a) nicht Teil eines systematischen und geplanten Prozesses zur Produktent… +
