Pages that link to "Template:DocumentData"
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The following pages link to Template:DocumentData:
Displaying 50 items.
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 55 (transclusion) (← links)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 59 (transclusion) (← links)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (3) (transclusion) (← links)
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.4 (transclusion) (← links)
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.3 (transclusion) (← links)
- Reference:AUT BASG - FAQ 11-Feb-2025 Änderung am Personal (transclusion) (← links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 (transclusion) (← links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 22-23 (transclusion) (← links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 24 (transclusion) (← links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 25 (transclusion) (← links)
- Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.110 (b) (2) (transclusion) (← links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 (transclusion) (← links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.31 (transclusion) (← links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.35 (transclusion) (← links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Audit (transclusion) (← links)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.2 (transclusion) (← links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - audit of a trial (transclusion) (← links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-002 (transclusion) (← links)
- Reference:IMDRF IMDRF – Guidelines - - (transclusion) (← links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex J (transclusion) (← links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.11 (transclusion) (← links)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 17 (transclusion) (← links)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 (transclusion) (← links)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-001 (transclusion) (← links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Inspection (transclusion) (← links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - inspection (transclusion) (← links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-003 (transclusion) (← links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11.2 (transclusion) (← links)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 78 (transclusion) (← links)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 5 (transclusion) (← links)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-002 (transclusion) (← links)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 5 (transclusion) (← links)
- Reference:EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 5 (transclusion) (← links)
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 a) (transclusion) (← links)
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 4.3 (transclusion) (← links)
- Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-002 (transclusion) (← links)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42c (transclusion) (← links)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 68 (transclusion) (← links)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 77 (transclusion) (← links)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 79 (transclusion) (← links)
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (l) (transclusion) (← links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.58 (transclusion) (← links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.68 (transclusion) (← links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.145 (transclusion) (← links)
- Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.1-002 (transclusion) (← links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Event (AE) (transclusion) (← links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Serious Adverse Event (SAE) (transclusion) (← links)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.1 (transclusion) (← links)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) (transclusion) (← links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse event (transclusion) (← links)