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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 Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation +
TAG-00045-Adv-hte ++ TAG-00261-Una-ner ++ TAG-00011-Inv-tud ++ TAG-00134-Eth-kom ++ TAG-00320-Foo-eri  +
I
ICH ICH E2A Guideline 1994 II B. Serious Adverse Event or Adverse Drug Reaction +
TAG-00046-Ser-sSc ++ TAG-00003-Adv-cht ++ TAG-00001-Med-rzn ++ TAG-00201-Cli-eSt  +
U
USA 21 CFR Part 312 09-Apr-2025 § 312.32 - SAE +
TAG-00046-Ser-sSc ++ TAG-00004-Ser-ege ++ TAG-00244-Def-ini ++ TAG-00258-Ser-nfü ++ TAG-00320-Foo-eri  +
G
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (o) +
TAG-00046-Ser-sSc ++ TAG-00004-Ser-ege ++ TAG-00244-Def-ini ++ TAG-00258-Ser-nfü  +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 serious adverse event +
TAG-00046-Ser-sSc ++ TAG-00004-Ser-ege ++ TAG-00047-Une-ete ++ TAG-00244-Def-ini ++ TAG-00258-Ser-nfü  +
GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6 +
TAG-00046-Ser-sSc ++ TAG-00017-Spo-die ++ TAG-00181-Man-npr ++ TAG-00201-Cli-eSt ++ TAG-00341-Res-ben  +
E
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 4 +
TAG-00046-Ser-sSc ++ TAG-00201-Cli-eSt ++ TAG-00017-Spo-die ++ TAG-00142-Mul-ent  +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 4 +
TAG-00046-Ser-sSc ++ TAG-00231-Per-ung ++ TAG-00017-Spo-die ++ TAG-00142-Mul-ent  +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 2 – 3 +
TAG-00046-Ser-sSc ++ TAG-00231-Per-ung ++ TAG-00208-Dev-ers ++ TAG-00017-Spo-die  +
I
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Serious Adverse Event (SAE) +
TAG-00046-Ser-sSc ++ TAG-00244-Def-ini ++ TAG-00258-Ser-nfü  +
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.45 +
TAG-00046-Ser-sSc ++ TAG-00244-Def-ini ++ TAG-00155-Med-Med ++ TAG-00258-Ser-nfü  +
G
GBR MEDDEV 2.7/3 revision 3 May-2015 4 +
TAG-00046-Ser-sSc ++ TAG-00244-Def-ini ++ TAG-00340-Req-nfo ++ TAG-00201-Cli-eSt ++ TAG-00155-Med-Med  +
W
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - serious adverse event +
TAG-00046-Ser-sSc ++ TAG-00244-Def-ini ++ TAG-00043-Goo-tek ++ TAG-00258-Ser-nfü  +
U
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28 +
TAG-00046-Ser-sSc ++ TAG-00244-Def-ini ++ TAG-00258-Ser-nfü ++ TAG-00320-Foo-eri  +
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21. +
TAG-00046-Ser-sSc ++ TAG-00244-Def-ini ++ TAG-00069-Imm-rhe ++ TAG-00258-Ser-nfü  +
W
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Investigator +
TAG-00046-Ser-sSc ++ TAG-00250-Inv-sme ++ TAG-00017-Spo-die ++ TAG-00134-Eth-kom ++ TAG-00057-Com-deR  +
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.10 +
TAG-00046-Ser-sSc ++ TAG-00250-Inv-sme ++ TAG-00246-Inv-hte ++ TAG-00329-Saf-lne ++ TAG-00017-Spo-die  +
G
GBR Directive 93/42/EEC 11-Oct-2007 Annex X +
TAG-00046-Ser-sSc ++ TAG-00251-Spo-ezu ++ TAG-00200-Cli-gKl ++ TAG-00201-Cli-eSt ++ TAG-00057-Com-deR  +
E
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 3 +
TAG-00046-Ser-sSc ++ TAG-00251-Spo-ezu ++ TAG-00201-Cli-eSt ++ TAG-00017-Spo-die  +
G
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 34 +
TAG-00048-Sus-ngV ++ TAG-00017-Spo-die ++ TAG-00329-Saf-lne ++ TAG-00008-Cli-ngK  +
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