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U
§ 812.43 Selecting investigators and monitors.
(a) Selecting investigators.
[…]
(b) Control of device
[…]
(c) Obtaining agreements [...] curriculum vi… +
§ 812.43 Selecting investigators and monitors.
(c) Obtaining agreements. A sponsor shall obtain from each participating investigator a signed agreemen… +
§ 812.45 Informing investigators.
A sponsor shall supply all investigators participating in the investigation with copies of the investigational plan … +
§ 812.46 Monitoring investigations
(a) Securing compliance. A sponsor who discovers that an investigator is not complying with the signed agreement, t… +
§ 812.46 Monitoring investigations
[…]
(b) Unanticipated adverse device effects.
(1) A sponsor shall immediately conduct an evaluation of any unantici… +
§ 812.46 Monitoring investigations
[…]
(b) Unanticipated adverse device effects.
[…]
(c) Resumption of terminated studies. If the device is a signific… +
§ 812.46 Monitoring investigations.
[…]
(b) Unanticipated adverse device effects.
(1) A sponsor shall immediately conduct an evaluation of any unantic… +
§ 812.7 Prohibition of promotion and other practices.
A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shal… +
D
§ 85 Zuständigkeiten und Aufgaben der Behörden
(1) Zuständige Behörden im Sinne der Verordnung (EU) 2017/745, der Verordnung (EU) 2017/746 und dieses … +
§ 9 Wesentliche Änderung einer klinischen Prüfung bei Menschen
(1) Die zuständige Ethik-Kommission gibt bei einem Antrag auf Genehmigung einer wesent… +
§ 96 Strafvorschriften
Mit Freiheitsstrafe bis zu einem Jahr oder mit Geldstrafe wird bestraft, wer
[…]
10. entgegen § 40 Absatz 1 die klinische Prüf… +
E
‘electronic signature’ means data in electronic form which is attached to or logically associated with other data in electronic form and which is used… +
G
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 adverse event adverse reaction +
“adverse event†means any untoward medical occurrence in a subject to whom a medicinal product has been administered, including occurrences which are … +
“electronic signature†means data in electronic form which are attached to or logically associated with other electronic data and which serve as a met… +
“in vitro diagnostic medical device†means a medical device which—
(a) is a reagent, reagent product, calibrator, control material, kit, instrument, a… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigational medicinal product +
“investigational medicinal product†means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be use… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigator +
“investigator†means, in relation to a clinical trial, the authorised health professional responsible for the conduct of that trial at a trial site, a… +
“medical device†means any instrument, apparatus, appliance, software, material or otherarticle, whether used alone or in combination, together with a… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 serious adverse event +
“serious adverse eventâ€, “serious adverse reaction†or “unexpected serious adverse reaction†means any adverse event, adverse reaction or unexpected a… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 unexpected adverse reaction +
“unexpected adverse reaction†means an adverse reaction the nature and severity of which is not consistent with the information about the medicinal pr… +
