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Property:RefTags

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

previous 202050100250500next 20
Showing 20 pages using this property.
G
GBR MEDDEV 2.7/3 revision 3 May-2015 7.1 +
TAG-00253-Rep-att ++ TAG-00046-Ser-sSc ++ TAG-00069-Imm-rhe ++ TAG-00017-Spo-die ++ TAG-00201-Cli-eSt  +
E
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001 +
TAG-00253-Rep-att ++ TAG-00069-Imm-rhe ++ TAG-00017-Spo-die ++ TAG-00057-Com-deR ++ TAG-00201-Cli-eSt  +
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002 +
TAG-00253-Rep-att ++ TAG-00069-Imm-rhe ++ TAG-00017-Spo-die ++ TAG-00057-Com-deR ++ TAG-00201-Cli-eSt  +
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001 +
TAG-00253-Rep-att ++ TAG-00250-Inv-sme ++ TAG-00017-Spo-die  +
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002 +
TAG-00253-Rep-att ++ TAG-00250-Inv-sme ++ TAG-00017-Spo-die  +
G
GBR MEDDEV 2.7/3 revision 3 May-2015 7.2 +
TAG-00253-Rep-att ++ TAG-00250-Inv-sme ++ TAG-00017-Spo-die ++ TAG-00046-Ser-sSc ++ TAG-00201-Cli-eSt  +
N
N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 - +
TAG-00256-GCP-CPZ ++ TAG-00345-Cou-ngs ++ TAG-00334-Tra-ngP  +
D
DEU Deutsches Ärzteblatt 45849 - +
TAG-00256-GCP-CPZ ++ TAG-00345-Cou-ngs ++ TAG-00075-Pub-ich ++ TAG-00257-Sit-zen  +
N
N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 - +
TAG-00256-GCP-CPZ ++ TAG-00345-Cou-ngs ++ TAG-00334-Tra-ngP ++ TAG-00257-Sit-zen  +
D
DEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und +
TAG-00256-GCP-CPZ ++ TAG-00345-Cou-ngs ++ TAG-00255-Inv-ion ++ TAG-00134-Eth-kom ++ TAG-00019-Pri-Prü  +
I
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.6 +
TAG-00257-Sit-zen ++ TAG-00334-Tra-ngP ++ TAG-00201-Cli-eSt ++ TAG-00060-Del-ben  +
E
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-001 +
TAG-00257-Sit-zen ++ TAG-00342-Sit-der ++ TAG-00334-Tra-ngP ++ TAG-00151-Sta-rat ++ TAG-00201-Cli-eSt  +
U
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.14. +
TAG-00258-Ser-nfü ++ TAG-00244-Def-ini ++ TAG-00252-Exp-hle ++ TAG-00046-Ser-sSc  +
USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) - +
TAG-00260-AEc-ugt ++ TAG-00259-AEs-ten ++ TAG-00045-Adv-hte  +
USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-002 +
TAG-00261-Una-ner ++ TAG-00038-Ear-tig ++ TAG-00137-Mon-che ++ TAG-00155-Med-Med ++ TAG-00320-Foo-eri  +
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV. +
TAG-00261-Una-ner ++ TAG-00134-Eth-kom ++ TAG-00250-Inv-sme ++ TAG-00011-Inv-tud ++ TAG-00320-Foo-eri  +
USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) +
TAG-00261-Una-ner ++ TAG-00137-Mon-che ++ TAG-00245-Spo-ten ++ TAG-00155-Med-Med ++ TAG-00320-Foo-eri  +
USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-001 +
TAG-00261-Una-ner ++ TAG-00137-Mon-che ++ TAG-00245-Spo-ten ++ TAG-00155-Med-Med ++ TAG-00320-Foo-eri  +
I
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.51 +
TAG-00261-Una-ner ++ TAG-00213-Ser-wie ++ TAG-00244-Def-ini ++ TAG-00155-Med-Med  +
U
USA 21 CFR Part 812 09-Apr-2025 § 812.3 (s) +
TAG-00261-Una-ner ++ TAG-00244-Def-ini ++ TAG-00155-Med-Med ++ TAG-00329-Saf-lne  +
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