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• Reference:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 -  + (-)
• Reference:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 -  + (-)
• Reference:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 -  + (-)
• Reference:GBR MHRA GCP Inspection Dossier template V7.0 -  + (-)
• Reference:USA WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 46114 -  + (-)
• Reference: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  + (-)
• Reference:ICH ICH E2F Guideline 2010 1  + (1)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-001  + (1.1)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-002  + (1.1)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Clinical Research  + (1.1 - Clinical Research)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - NIS  + (1.1 - NIS)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Platform, basket and umbrella trials  + (1.1 - Platform, basket and umbrella trials)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.2  + (1.2)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.3  + (1.3)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3  + (1.3)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.4  + (1.4)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 1.4  + (1.4)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4  + (1.4)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.1  + (10.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.2  + (10.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.3  + (10.3)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.3  + (10.3)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.4  + (10.4)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6  + (10.6)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7  + (10.7)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 (e)  + (10.7 (e))

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.8  + (10.8)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11  + (11)
• Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 11 d)  + (11 d))
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11.2  + (11.2)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 13  + (13)
• Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14  + (14)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2  + (2)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2.  + (2.)
• Reference:ICH ICH E21 Concept paper 2023 2.  + (2.)
• Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-001  + (2.)
• Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-001  + (2.)
• Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-002  + (2.)
• Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-002  + (2.)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.1  + (2.1)
• Reference:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 2.1  + (2.1)
• Reference:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 2.1  + (2.1)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1.  + (2.1.1.)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.14.  + (2.1.14.)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2  + (2.1.2)
• Reference:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 2.1.2  + (2.1.2)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21.  + (2.1.21.)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28  + (2.1.28)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.1.3  + (2.1.3)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.32 - 2.1.34  + (2.1.32 - 2.1.34)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.1.8  + (2.1.8)