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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.
U
USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 2. +
TAG-00064-Ele-eUn ++ TAG-00150-Sou-eUr ++ TAG-00124-Cas-Prü ++ TAG-00125-Ele-ekt ++ TAG-00320-Foo-eri  +
USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6) +
TAG-00064-Ele-eUn ++ TAG-00286-Ele-sch ++ TAG-00244-Def-ini ++ TAG-00320-Foo-eri  +
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III B. 3. +
TAG-00065-Sou-nüb ++ TAG-00295-Rem-erp ++ TAG-00137-Mon-che ++ TAG-00124-Cas-Prü ++ TAG-00150-Sou-eUr  +
I
ICH ICH E2A Guideline 1994 III A. 1. +
TAG-00066-Cau-enh ++ TAG-00003-Adv-cht ++ TAG-00297-Ind-erh ++ TAG-00201-Cli-eSt ++ TAG-00017-Spo-die  +
E
EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.2 +
TAG-00066-Cau-enh ++ TAG-00003-Adv-cht ++ TAG-00067-Exp-war ++ TAG-00008-Cli-ngK  +
G
GBR MEDDEV 2.7/3 revision 3 May-2015 8 +
TAG-00066-Cau-enh ++ TAG-00155-Med-Med ++ TAG-00045-Adv-hte ++ TAG-00261-Una-ner  +
U
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2 +
TAG-00066-Cau-enh ++ TAG-00244-Def-ini ++ TAG-00045-Adv-hte ++ TAG-00018-Inv-die  +
USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) - (b) +
TAG-00068-Dev-gsb ++ TAG-00011-Inv-tud ++ TAG-00320-Foo-eri ++ TAG-00017-Spo-die  +
F
FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 3. +
TAG-00068-Dev-gsb ++ TAG-00155-Med-Med ++ TAG-00321-Age-pro ++ TAG-00329-Saf-lne  +
U
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4 +
TAG-00068-Dev-gsb ++ TAG-00245-Spo-ten ++ TAG-00011-Inv-tud ++ TAG-00155-Med-Med ++ TAG-00320-Foo-eri  +
G
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 35 +
TAG-00068-Dev-gsb ++ TAG-00251-Spo-ezu ++ TAG-00057-Com-deR ++ TAG-00017-Spo-die  +
E
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 43 +
TAG-00068-Dev-gsb ++ TAG-00251-Spo-ezu ++ TAG-00011-Inv-tud ++ TAG-00058-Eur-zne ++ TAG-00277-Pla-par  +
I
ICH ICH E2F Guideline 2010 1 +
TAG-00068-Dev-gsb ++ TAG-00317-Obj-set ++ TAG-00329-Saf-lne ++ TAG-00001-Med-rzn  +
D
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 5 +
TAG-00069-Imm-rhe ++ TAG-00008-Cli-ngK ++ TAG-00029-Inf-rte  +
G
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-001 +
TAG-00069-Imm-rhe ++ TAG-00017-Spo-die ++ TAG-00246-Inv-hte ++ TAG-00057-Com-deR ++ TAG-00134-Eth-kom  +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-002 +
TAG-00069-Imm-rhe ++ TAG-00017-Spo-die ++ TAG-00246-Inv-hte ++ TAG-00134-Eth-kom ++ TAG-00057-Com-deR  +
E
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 54 +
TAG-00069-Imm-rhe ++ TAG-00017-Spo-die ++ TAG-00246-Inv-hte ++ TAG-00177-Ben-koB ++ TAG-00262-CTI-Kli  +
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 2-3 +
TAG-00069-Imm-rhe ++ TAG-00029-Inf-rte ++ TAG-00027-Inc-son  +
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 1 +
TAG-00069-Imm-rhe ++ TAG-00029-Inf-rte ++ TAG-00028-Leg-ich ++ TAG-00008-Cli-ngK  +
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 68 +
TAG-00069-Imm-rhe ++ TAG-00029-Inf-rte ++ TAG-00201-Cli-eSt ++ TAG-00155-Med-Med  +
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