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Property:RefTags

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Raw TAG-ID list for this reference (used for glossary queries).

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Showing 20 pages using this property.
F
FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-001 +
TAG-00069-Imm-rhe ++ TAG-00046-Ser-sSc ++ TAG-00279-Hea-rFr ++ TAG-00321-Age-pro ++ TAG-00155-Med-Med  +
E
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 6 +
TAG-00069-Imm-rhe ++ TAG-00211-Rec-ukt ++ TAG-00017-Spo-die ++ TAG-00202-Inv-Pro ++ TAG-00201-Cli-eSt  +
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 53 +
TAG-00069-Imm-rhe ++ TAG-00329-Saf-lne ++ TAG-00177-Ben-koB ++ TAG-00262-CTI-Kli ++ TAG-00251-Spo-ezu  +
EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 2.1 +
TAG-00071-Pre-nis ++ TAG-00001-Med-rzn ++ TAG-00176-Ris-erh ++ TAG-00025-Sub-mer  +
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 33 +
TAG-00071-Pre-nis ++ TAG-00029-Inf-rte ++ TAG-00008-Cli-ngK  +
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 66 +
TAG-00071-Pre-nis ++ TAG-00029-Inf-rte ++ TAG-00201-Cli-eSt ++ TAG-00155-Med-Med  +
U
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1 +
TAG-00071-Pre-nis ++ TAG-00045-Adv-hte ++ TAG-00297-Ind-erh ++ TAG-00025-Sub-mer  +
USA 45 CFR Part 46 09-Apr-2025 Subpart B +
TAG-00071-Pre-nis ++ TAG-00134-Eth-kom ++ TAG-00340-Req-nfo ++ TAG-00029-Inf-rte  +
C
CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 19 +
TAG-00071-Pre-nis ++ TAG-00154-Vul-eil ++ TAG-00025-Sub-mer  +
I
ICH ICH E21 Concept paper 2023 2. +
TAG-00071-Pre-nis ++ TAG-00154-Vul-eil ++ TAG-00029-Inf-rte ++ TAG-00001-Med-rzn  +
ICH ICH E8 Guideline R1 (2021) 4.3.3.1 +
TAG-00071-Pre-nis ++ TAG-00201-Cli-eSt ++ TAG-00025-Sub-mer ++ TAG-00001-Med-rzn  +
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.2 +
TAG-00072-Ins-her ++ TAG-00017-Spo-die ++ TAG-00201-Cli-eSt ++ TAG-00131-Ess-sun  +
G
GBR Directive 2001/20/EC 04-Apr-2001 Article 3 +
TAG-00072-Ins-her ++ TAG-00025-Sub-mer ++ TAG-00017-Spo-die ++ TAG-00018-Inv-die  +
D
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 26 +
TAG-00072-Ins-her ++ TAG-00025-Sub-mer ++ TAG-00017-Spo-die ++ TAG-00201-Cli-eSt ++ TAG-00231-Per-ung  +
W
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c) +
TAG-00072-Ins-her ++ TAG-00029-Inf-rte ++ TAG-00025-Sub-mer ++ TAG-00031-Pat-onA  +
G
GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2. ; 2.2 +
TAG-00072-Ins-her ++ TAG-00157-Cus-ung ++ TAG-00201-Cli-eSt ++ TAG-00181-Man-npr ++ TAG-00155-Med-Med  +
D
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40a Absatz 3 +
TAG-00072-Ins-her ++ TAG-00245-Spo-ten ++ TAG-00017-Spo-die ++ TAG-00008-Cli-ngK  +
I
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.14-001 +
TAG-00072-Ins-her ++ TAG-00280-Fin-anT ++ TAG-00017-Spo-die ++ TAG-00111-Agr-chr ++ TAG-00018-Inv-die  +
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.14-002 +
TAG-00072-Ins-her ++ TAG-00280-Fin-anT ++ TAG-00017-Spo-die ++ TAG-00111-Agr-chr ++ TAG-00018-Inv-die  +
E
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 69 +
TAG-00072-Ins-her ++ TAG-00340-Req-nfo ++ TAG-00201-Cli-eSt ++ TAG-00155-Med-Med  +
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