Property:DocType

Document type (Legal act, Regulation, Guideline, …).

Usage171

Filter<p>The <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Property_page/Filter">search filter</a> allows the inclusion of <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Query_expressions">query expressions</a> such as <code>~</code> or <code>!</code>. The selected <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Query_engine">query engine</a> might also support case insensitive matching or other short expressions like:</p><ul><li><code>in:</code> result should include the term, e.g. '<code>in:Foo</code>'</li></ul><ul><li><code>not:</code> result should to not include the term, e.g. '<code>not:Bar</code>'</li></ul>

Showing 20 pages using this property.

N

N.A. Article from Mora et al. 2023 +

Litterature article +

N.A. SPIRIT 2013 - Chan et al. 2013 +

Litterature article +

E

EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 +

Official guideline +

EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 +

Official guideline +

EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 +

Official guideline +

EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 +

Official guideline +

EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 +

Official guideline +

EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 +

Official guideline +

EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 +

Official guideline +

EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 +

Official guideline +

EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) +

Official guideline +

EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024) +

Official guideline +

G

GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 +

Official guideline +

GBR MEDDEV 2.7/3 revision 3 May-2015 +

Official guideline +

D

DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021 +

Official recommendation +

DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 +

Official recommendation +

DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 +

Official recommendation +

E

EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) +

Official recommendation +

EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 +

Official recommendation +

EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 +

Official recommendation +

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	This page was last edited on 7 October 2026, at 03:52. Content is available under Creative Commons Attribution unless otherwise noted. Datenschutzrichtlinie Impressum
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