79C3C34C52B45572883A05D425EB0F82
Regulation on Leading Ethics Committees (2004)
https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20003352
http://leaux.net/URLS/ConvertAPI Text Files/E41226AB573037AA16B3FB07C0454899.en.txt
Examining the file media/Synopses/E41226AB573037AA16B3FB07C0454899.html:
This file was generated: 2020-12-25 03:35:26
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Social / Property Ownership
Searching for indicator home:
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p.(None): Home Contact Sitemap Imprint Deutsch
p.(None): [Federal law] State law Municipal law Judiciary Other announcements, decrees Total query
p.(None): Federal law consolidated: Entire legal regulation for the Ethics Committee Regulation, version of 02/18/2020 Print preview
p.(None): Other formats:
p.(None): long Title
p.(None): Ordinance of the Federal Minister for Health and Women regarding the special requirements for ethics committees in the context of multicentre
p.(None): clinical trials (lead ethics commission regulation)
p.(None): StF: BGBl. II No. 214/2004
p.(None): modification
p.(None): BGBl. II No. 23/2020
p.(None): Preamble / Promulgatory
p.(None): According to Section 41b (1) of the Medicinal Products Act, Federal Law Gazette No. 185/1983, last amended by Federal Law Gazette I No. 35/2004, the following is prescribed:
p.(None): text
p.(None): § 1. An ethics committee for the assessment in the context of a multi-center clinical trial has the criteria and in §§ 2 to 7
p.(None): Requirements.
p.(None): § 2. In organizational terms, the ethics committee has to
p.(None): 1. an office that is open to the public and staffed on fixed working days, and
p.(None): 2. sufficient capacities to process applications within the time limits specified in the Medicinal Products Act,
p.(None): feature.
p.(None): § 3. (1) The ethics committee must have sufficient experience in assessing clinical trials in a variety of representative different ways
...
Social / Women
Searching for indicator women:
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p.(None): Home Contact Sitemap Imprint Deutsch
p.(None): [Federal law] State law Municipal law Judiciary Other announcements, decrees Total query
p.(None): Federal law consolidated: Entire legal regulation for the Ethics Committee Regulation, version of 02/18/2020 Print preview
p.(None): Other formats:
p.(None): long Title
p.(None): Ordinance of the Federal Minister for Health and Women regarding the special requirements for ethics committees in the context of multicentre
p.(None): clinical trials (lead ethics commission regulation)
p.(None): StF: BGBl. II No. 214/2004
p.(None): modification
p.(None): BGBl. II No. 23/2020
p.(None): Preamble / Promulgatory
p.(None): According to Section 41b (1) of the Medicinal Products Act, Federal Law Gazette No. 185/1983, last amended by Federal Law Gazette I No. 35/2004, the following is prescribed:
p.(None): text
p.(None): § 1. An ethics committee for the assessment in the context of a multi-center clinical trial has the criteria and in §§ 2 to 7
p.(None): Requirements.
p.(None): § 2. In organizational terms, the ethics committee has to
p.(None): 1. an office that is open to the public and staffed on fixed working days, and
p.(None): 2. sufficient capacities to process applications within the time limits specified in the Medicinal Products Act,
p.(None): feature.
p.(None): § 3. (1) The ethics committee must have sufficient experience in assessing clinical trials in a variety of representative different ways
p.(None): Special subjects. This is the case if the ethics committee - or its legal predecessor - has existed for at least three years and during this time
p.(None): has assessed a large number of clinical trials in different phases.
p.(None): (2) For cases in which the expertise of the members is not sufficient for assessment, the ethics committee, taking into account those in the Medicinal Products Act
p.(None): to have a procedure for involving external experts.
...
Orphaned Trigger Words
p.(None): clinical trials (lead ethics commission regulation)
p.(None): StF: BGBl. II No. 214/2004
p.(None): modification
p.(None): BGBl. II No. 23/2020
p.(None): Preamble / Promulgatory
p.(None): According to Section 41b (1) of the Medicinal Products Act, Federal Law Gazette No. 185/1983, last amended by Federal Law Gazette I No. 35/2004, the following is prescribed:
p.(None): text
p.(None): § 1. An ethics committee for the assessment in the context of a multi-center clinical trial has the criteria and in §§ 2 to 7
p.(None): Requirements.
...
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| home | Property Ownership |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
ethics
Applicable Type / Vulnerability / Indicator Overlay for this Input