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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 1 +
Recording and reporting of adverse events that occur during performance studies
1. The sponsor shall fully record all of the following:
(a) any ad… +
Recording, processing, handling and storage of information
1. All clinical trial information shall be recorded, processed, handled, and stored by t… +
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Regulatory Authorities
Bodies having the power to regulate, including those that review submitted protocols and clinical data and those that conduct … +
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GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 - +
Remote direct access to Electronic Health Records (EHR) by Sponsor Monitors (or Auditors) in clinical trials
[...]
Remote direct access to the health … +
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Reporting of adverse events and serious adverse events by the investigator to the sponsor
1. The investigator shall record and document adverse eve… +
Reporting of adverse events and serious adverse events by the investigator to the sponsor
1. The investigator shall record and document adverse eve… +
Reporting of serious breaches
1. The sponsor shall notify the Member States concerned about a serious breach of this Regulation or of the version o… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 82 Paragraph 3 – 5 +
Reporting of serious incidents and field safety corrective actions
3. Manufacturers shall report any serious incident as referred to in point (a) i… +
Reporting of serious incidents and field safety corrective actions
1. Manufacturers of devices made available on the Union market, other than inves… +
Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency
1. The sponsor of a clinical trial performed in at least o… +
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Request for authorisation to conduct a clinical trial
17.—(1) A request for authorisation to conduct a clinical trial shall be made to the licensing a… +
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Requirements regarding other clinical investigations
1. Clinical investigations, not performed pursuant to any of the purposes listed in Article 62… +
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Research Ethics Committees
23. The protocol must be submitted for consideration, comment, guidance, and approval to the concerned research ethics com… +
Research Ethics Committees
23. […] No amendment to the protocol may be made without consideration and approval by the committee. [...]… +
Research Ethics Committees
23. […] The committee must have the right to monitor, recommend changes to, withdraw approval for, and suspend ongoing res… +
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Resubmission
This Chapter is without prejudice to the possibility for the sponsor to resubmit, following the refusal to grant an authorisation or the… +
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Review and appeal relating to ethics committee opinion
16.—(1) This regulation applies where a chief investigator for a trial has been notified by the… +
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DEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und +
Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen vo… +
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SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials
Publication: Annals of Internal Medicine ; Volume 158, Number 3
https://ww… +
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STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES
1.For custom-made devices or for devices intended for clinical investigations the manufacturer or hi… +
