Property:RefPreview
From GxPlex
Auto-derived 200-character preview of this reference's content, used in Document pages' References list.
D
§ 68 Überwachung von klinischen Prüfungen, Leistungsstudien und sonstigen klinischen Prüfungen durch die zuständige Behörde
(1) Die zuständige Behörd… +
§ 7 Prüfung der nach Artikel 7 der Verordnung (EU) Nr. 536/2014 in Teil II des Bewertungsberichts zu behandelnden Aspekte
(1) Die zuständige Ethik-Ko… +
§ 77 Durchführung der Überwachung
(1) Der Überwachung durch die zuständigen Behörden unterliegen
1. Betriebe und Einrichtungen, in denen Produkte und… +
§ 79 Behördliche Befugnisse im Rahmen der Durchführung der Vigilanz und der Überwachung
(1) Die mit der Risikobewertung und der Überwachung beauftrag… +
§ 8 Hinzufügung eines zusätzlichen Mitgliedstaats der Europäischen Union
(1) Wünscht der Sponsor eine genehmigte klinische Prüfung bei Menschen nach … +
U
§ 809.3 Definitions.
(a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or o… +
§ 812.1 Scope.
(a) […] This part provides procedures for the conduct of clinical investigations of devices. An approved investigational device exempti… +
§ 812.100 General responsibilities of investigators.
An investigator is responsible for ensuring that an investigation is conducted according to the s… +
§ 812.110 Specific responsibilities of investigators.
(b) Compliance. An investigator shall conduct an investigation in accordance with the signed agr… +
§ 812.110 Specific responsibilities of investigators.
(c) Supervising device use. An investigator shall permit an investigational device to be used on… +
§ 812.119 Disqualification of a clinical investigator.
[…]… +
§ 812.140 Records.
(a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relati… +
§ 812.140 Records.
[…]
(a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records rel… +
§ 812.140 Records.
[…]
(a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records rel… +
§ 812.140 Records.
[…]
(b) Sponsor records.[...]
(5) Records concerning adverse device effects (whether anticipated or unanticipated) and complaints
[… +
§ 812.140 Records.
[…]
(d) Retention period. An investigator or sponsor shall maintain the records required by this subpart during the investigation a… +
§ 812.140 Records.
[…]
(e) Records custody. An investigator or sponsor may withdraw from the responsibility to maintain records for the period require… +
§ 812.145 Inspections
(a) Entry and inspection. A sponsor or an investigator who has authority to grant access shall permit authorized FDA employees, … +
§ 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:
(2) Withd… +
§ 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:
(1) Unant… +
