Property:RefPreview
From GxPlex
Auto-derived 200-character preview of this reference's content, used in Document pages' References list.
D
§ 10 Bewertungsverfahren nach Artikel 44 der Verordnung (EU) Nr. 536/2014
Die zuständige Ethik-Kommission übermittelt ihre Bewertung nach § 40c Absat… +
§ 10 Dokumentationspflicht
(3) Ärztliche Aufzeichnungen sind für die Dauer von zehn Jahren nach Abschluss der Behandlung aufzubewahren, soweit nicht … +
§ 11 Korrekturmaßnahmen
Die zuständige Bundesoberbehörde informiert die zuständige Ethik-Kommission über beabsichtigte Korrekturmaßnahmen nach § 42 A… +
U
§ 11.200 Electronic signature components and controls
(a) Electronic signatures that are not based upon biometrics shall:
(1) Employ at least two d… +
§ 11.24 When must clinical trial registration information be submitted?
(a) General. Except as provided in paragraph (b) of this section, the respons… +
§ 11.3 Definitions
[…]
(b) The following definitions of terms also apply to this part:
[…]
(6) Electronic record means any combination of text, graphi… +
§ 11.3 Definitions
[…]
(b) The following definitions of terms also apply to this part:
[…]
(5) Digital signature means an electronic signature based u… +
§ 11.30 Controls for open systems.
Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures an… +
§ 11.300 Controls for identification codes/passwords.
Persons who use electronic signatures based upon use of identification codes in combination with… +
§ 11.4 To whom does this part apply?
[…]
(c) Determination of responsible party. For purposes of this part, each applicable clinical trial or other cl… +
§ 11.40 Who must submit clinical trial results information?
The responsible party for an applicable clinical trial specified in § 11.42 must submit cl… +
§ 11.44 When must clinical trial results information be submitted for applicable clinical trials
subject to § 11.42?
(a) Standard submission deadline.… +
§ 11.50 Signature manifestations
(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the… +
§ 11.54 What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission?
[…]… +
§ 11.6 What are the requirements for the submission of truthful information?
The clinical trial information submitted by a responsible party under thi… +
§ 11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected?
(a) Updates.
[…]
(b) Corrections—
[…]… +
§ 11.70 Signature/record linking.
Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective … +
§ 11.8 In what format must clinical trial information be submitted?
Information submitted under this part must be submitted electronically to Clinical… +
D
§ 15 Forschung
(1) Ärztinnen und Ärzte, die sich an einem Forschungsvorhaben beteiligen, bei dem in die psychische oder körperliche Integrität eines … +
U
§ 164.304 Definitions.
[…]
Access means the ability or the means necessary to read, write, modify, or communicate data/information or otherwise use an… +
