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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.
E
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 32-34 +
TAG-00045-Adv-hte ++ TAG-00046-Ser-sSc ++ TAG-00244-Def-ini ++ TAG-00258-Ser-nfü  +
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1 +
TAG-00045-Adv-hte ++ TAG-00071-Pre-nis ++ TAG-00003-Adv-cht ++ TAG-00066-Cau-enh ++ TAG-00033-Pro-oto  +
U
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1 +
TAG-00045-Adv-hte ++ TAG-00084-Bas-esu ++ TAG-00259-AEs-ten ++ TAG-00340-Req-nfo  +
I
ICH ICH E19 Guideline 2022 6 +
TAG-00045-Adv-hte ++ TAG-00137-Mon-che ++ TAG-00017-Spo-die ++ TAG-00250-Inv-sme  +
W
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Sponsor +
TAG-00045-Adv-hte ++ TAG-00137-Mon-che ++ TAG-00033-Pro-oto ++ TAG-00343-Doc-ten  +
E
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 1-2 +
TAG-00045-Adv-hte ++ TAG-00208-Dev-ers ++ TAG-00203-Cli-lin ++ TAG-00201-Cli-eSt ++ TAG-00017-Spo-die  +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 1 +
TAG-00045-Adv-hte ++ TAG-00232-Per-die ++ TAG-00231-Per-ung ++ TAG-00208-Dev-ers ++ TAG-00017-Spo-die  +
U
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1. +
TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00001-Med-rzn  +
I
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Event (AE) +
TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00066-Cau-enh  +
U
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2 +
TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00252-Exp-hle  +
USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event +
TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00320-Foo-eri ++ TAG-00001-Med-rzn  +
W
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse event +
TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00043-Goo-tek ++ TAG-00066-Cau-enh  +
U
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.1 +
TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00252-Exp-hle ++ TAG-00340-Req-nfo  +
E
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 60 – 62 +
TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00231-Per-ung ++ TAG-00285-Pha-enk  +
I
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.2 +
TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00155-Med-Med ++ TAG-00192-Use-kta  +
E
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 57 – 59 +
TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00201-Cli-eSt ++ TAG-00208-Dev-ers ++ TAG-00220-Inv-agn  +
G
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m) +
TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00066-Cau-enh ++ TAG-00001-Med-rzn  +
W
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Investigator +
TAG-00045-Adv-hte ++ TAG-00246-Inv-hte ++ TAG-00062-Med-tre ++ TAG-00343-Doc-ten  +
E
EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1 +
TAG-00045-Adv-hte ++ TAG-00252-Exp-hle ++ TAG-00066-Cau-enh ++ TAG-00067-Exp-war ++ TAG-00258-Ser-nfü  +
I
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex F +
TAG-00045-Adv-hte ++ TAG-00259-AEs-ten  +
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