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List of results

• Document:FRA Infographie - La hiérarchie des normes 22-Mar-2024  + (Infographie - La hiérarchie des normes)
• Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023  + (Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors)
• Document:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022  + (KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung)
• Document:AUT LekV – Leit-Ethikkommissions-Verordnung 29-Nov-2024  + (LekV – Leit-Ethikkommissions-Verordnung)
• Document:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021  + (MBO - Berufsordnung der Ärzt:innen)
• Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020  + (MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices)
• Document:EU MDCG Guidelines -  + (MDCG Guidelines)
• Document:GBR MEDDEV 2.7/3 revision 3 May-2015  + (MEDDEV 2.7/3 revision 3)
• Document:GBR MHRA GCP Inspection Dossier template V7.0  + (MHRA GCP Inspection Dossier template)
• Document:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021  + (MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung)
• Document:DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021  + (MPBetreibV - Medizinprodukte-Betreiberverordnung)
• Document:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022  + (MPDG - Medizinprodukterecht-Durchführungsgesetz)
• Document:AUT MPG – Medizinproduktegesetz 26-May-2022  + (MPG – Medizinproduktegesetz)
• Document:GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021  + (Making changes to a research study to manage the impact of COVID-19)
• Document:GBR Medicines and Medical Devices Act 2021 21-Feb-2021  + (Medicines and Medical Devices Act 2021)
• Document:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0  + (Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training)
• Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024  + (NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs)
• Document:GBR NHS: Records Management Code of Practice 07-Aug-2023  + (NHS: Records Management Code of Practice)
• Document:USA NIH - SCORE Manual N.A.  + (NIH - SCORE Manual)
• Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025  + (NIH - SCORE Manual: Appendix Source Documents Requirements)
• Document:USA NIH - Glossary 27-May-2025  + (NIH - Glossary)
• Document:GBR NIHR - National Institute for Health and Care Research 28-Jan-2025  + (NIHR - National Institute for Health and Care Research)
• Document:GBR National Health Service Act 2006 02-Dec-2019  + (National Health Service Act 2006)
• Document:INT Nuremberg Code 1947  + (Nuremberg Code)
• Document:AUT Question - BASG 11-Feb-2025  + (Question - BASG)

• Document:USA Recognized Consensus Standards N.A.  + (Recognized Consensus Standards)

• Document:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020  + (Recognized Consensus Standards - ISO 14155)
• Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017  + (Recommendations of the expert group - Risk proportionate approaches in clinical trials)
• Document:EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023  + (Regulation (EC) No 1223/2009 - Cosmetic Products)
• Document:EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022  + (Regulation (EC) No 178/2002 - Food Safety)
• Document:EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22  + (Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use)
• Document:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016  + (Regulation (EU) 2016/679 (GDPR))
• Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble  + (Regulation (EU) 2017/745 - Medical Device Regulation)
• Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023  + (Regulation (EU) 2017/745 - Medical Device Regulation)
• Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble  + (Regulation (EU) 2017/746 - in vitro diagnostic medical devices)
• Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023  + (Regulation (EU) 2017/746 - in vitro diagnostic medical devices)
• Document:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022  + (Regulation (EU) 536/2014 - clinical trials)
• Document:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble  + (Regulation (EU) 536/2014 - clinical trials)
• Document:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014  + (Regulation (EU) 910/2014 - electronic identification)
• Document:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12  + (Regulation (EU) No 520/2012 - performance of pharmacovigilance activities)
• Document:DEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und  + (Richtlinie zur Bewertung der Qualifikation … Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und Bundesärztekammerik Deutschland e. V. und Bundesärztekammer)
• Document:DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988  + (SGB V - Sozialgesetzbuch Fünftes Buch)
• Document:FRA SI RIPH 2G - Website 16-May-2025  + (SI RIPH 2G - Website)
• Document:SMW Test  + (SMW Test Document)
• Document:N.A. SPIRIT 2013 - Chan et al. 2013  + (SPIRIT 2013 - Chan et al.)
• Document:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025  + (SURV_VIG_DOC118 V01 REC-Avis aux promoteurs -Partie V)
• Document:DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022  + (StrlSchG - Strahlenschutzgesetz)
• Document:DEU StrlSchV - Strahlenschutzverordnung 08-Oct-2021  + (StrlSchV - Strahlenschutzverordnung)
• Document:DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024  + (TAMG - Tierarzneimittelgesetz)
• Document:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019  + (The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019)
• Document:GBR The Human Medicines Regulations 2012 01-Jan-2025  + (The Human Medicines Regulations 2012)