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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.
E
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3 +
TAG-00152-Tri-gat ++ TAG-00017-Spo-die ++ TAG-00135-Inv-ntr ++ TAG-00343-Doc-ten  +
I
ICH ICH E6 Guideline R3 (2025) Appendix C C.2.3 +
TAG-00152-Tri-gat ++ TAG-00131-Ess-sun ++ TAG-00017-Spo-die ++ TAG-00135-Inv-ntr  +
E
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 57 +
TAG-00152-Tri-gat ++ TAG-00131-Ess-sun ++ TAG-00245-Spo-ten ++ TAG-00246-Inv-hte ++ TAG-00008-Cli-ngK  +
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.2 +
TAG-00152-Tri-gat ++ TAG-00343-Doc-ten ++ TAG-00033-Pro-oto ++ TAG-00148-Con-rsc  +
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.3 +
TAG-00152-Tri-gat ++ TAG-00343-Doc-ten ++ TAG-00134-Eth-kom ++ TAG-00057-Com-deR  +
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5 +
TAG-00152-Tri-gat ++ TAG-00343-Doc-ten ++ TAG-00149-Sig-nds ++ TAG-00060-Del-ben ++ TAG-00327-Exa-spi  +
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 10 +
TAG-00154-Vul-eil ++ TAG-00026-Min-isc ++ TAG-00027-Inc-son ++ TAG-00059-Reg-lat  +
W
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 e) - g) +
TAG-00154-Vul-eil ++ TAG-00029-Inf-rte ++ TAG-00281-Und-sse ++ TAG-00025-Sub-mer  +
WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 22 +
TAG-00154-Vul-eil ++ TAG-00029-Inf-rte ++ TAG-00279-Hea-rFr ++ TAG-00026-Min-isc  +
C
CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18 +
TAG-00154-Vul-eil ++ TAG-00071-Pre-nis ++ TAG-00025-Sub-mer  +
W
WHO WHO - Guidance for best practices for clinical trials 2024 2.1.3 +
TAG-00154-Vul-eil ++ TAG-00071-Pre-nis ++ TAG-00026-Min-isc ++ TAG-00327-Exa-spi ++ TAG-00078-Exc-ssk  +
I
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.7 +
TAG-00154-Vul-eil ++ TAG-00201-Cli-eSt ++ TAG-00134-Eth-kom  +
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Vulnerable Participants +
TAG-00154-Vul-eil ++ TAG-00244-Def-ini ++ TAG-00281-Und-sse  +
U
USA 45 CFR Part 46 09-Apr-2025 Subpart C +
TAG-00154-Vul-eil ++ TAG-00244-Def-ini ++ TAG-00134-Eth-kom ++ TAG-00025-Sub-mer  +
I
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.55 +
TAG-00154-Vul-eil ++ TAG-00244-Def-ini ++ TAG-00155-Med-Med ++ TAG-00281-Und-sse  +
ICH ICH E7 Guideline 1993 - +
TAG-00154-Vul-eil ++ TAG-00339-Spe-nBe ++ TAG-00008-Cli-ngK  +
U
USA 21 CFR Part 812 09-Apr-2025 § 812.27 +
TAG-00155-Med-Med ++ TAG-00204-Cli-tbe ++ TAG-00343-Doc-ten ++ TAG-00320-Foo-eri  +
I
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-001 +
TAG-00155-Med-Med ++ TAG-00244-Def-ini  +
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-002 +
TAG-00155-Med-Med ++ TAG-00244-Def-ini  +
E
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 1 - 3 +
TAG-00155-Med-Med ++ TAG-00244-Def-ini ++ TAG-00316-Del-sbe  +
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