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Property:RefModule

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Module number this reference belongs to.

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Showing 20 pages using this property.
E
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 7 – 8 +
2  +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 1.12 +
2  +
D
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-001 +
2  +
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 5 – 6 +
2  +
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 30-002 +
2  +
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-001 +
2  +
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 65 +
2  +
U
USA 21 CFR Part 312 09-Apr-2025 § 312.53 (viii) +
2  +
USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A. +
2  +
I
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.2 +
2  +
W
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.7 +
2  +
I
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.3 +
2  +
E
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 50 +
2  +
D
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.9 +
2  +
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.4 +
2  +
G
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (d) +
2  +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. +
2  +
I
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.5 +
2  +
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Agreement +
2  +
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.6 +
2  +
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