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5.8.3 Special circumstances for informed consent
5.8.3.1 General
The provisions given in 5.8.3.2 to 5.8.3.4 are subject to national regulations.
5.8… +
5.8.4 Information to be provided to the subject
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5.8.5 Informed consent signature
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5.8.6 New information
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6 Clinical investigation planning
6.1 General
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6. During the period when the application is being assessed, the Member State may request additional information from the sponsor. The expiry of the… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 66 Paragraph 6 – 7 +
6. During the period when the application is being assessed the Member State may request additional information from the sponsor. The expiry of the … +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 6 – 7 +
6. The Commission shall issue guidelines regarding the content and structure of the summary of the performance study report.
In addition, the Commi… +
6. The Commission shall issue guidelines regarding the content and structure of the summary of the clinical investigation report.
In addition, the … +
6. The subject shall be informed that a clinical investigation report and a summary presented in terms understandable to the intended user will be m… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 6 – 7 +
6. The subject shall be informed that a report of the performance study and a summary presented in terms understandable to the intended user will be… +
6. The subject shall be informed that the summary of the results of the clinical trial and a summary presented in terms understandable to a layperso… +
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6. RESPONSIBILITIES OF THE MONITOR
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6.2 Assessment of the trial site
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6.3 Staff education and compliance
The monitor should ensure that all staf… +
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6. The Sponsor shall provide evidence that the investigation is being conducted in line with good clinical practice, for instance through internal or … +
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6.1.4 Access to Interim Data
Inappropriate access to data during the conduct of the study may compromise study integrity (Sections 5.5 and 5.6 and ICH… +
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6.2 Assessment of the trial site
The monitor should assess the trial site prior to the clinical trial to ensure that the facilities (including laborat… +
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6.2.2 Withdrawal Criteria
Clear criteria for stopping treatment or study procedures for a study participant while remaining in the study are necessary… +
6.3 Justification for the design of the clinical investigation
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The clinical investigation shall be designed to evaluate […]… +
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EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 6.4 +
6.4. Principal Investigator
The principal investigator should have a process in place to ensure that:
• the site staff or service providers delegated… +
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6.9 Agreement(s)
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7 .6 Additional members of the investigation site team
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 7 – 8 +
7. The investigator shall be a person exercising a profession which is recognised in the Member State concerned, as qualifying for the role of inves… +
