Pages that link to "Glossary:TAG-00149-Sig-nds"
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The following pages link to Glossary:TAG-00149-Sig-nds:
Displaying 17 items.
- Glossary (â links)
- Reference: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 5.1 - 5.2-001 (â links)
- Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5 (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - witness (â links)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 1 (â links)
- Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Introduction (â links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.4 - 5.8.6 (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Certified Copy (â links)
- Reference: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 5.1 - 5.2-002 (â links)
- Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 GLOSSARY OF TERMS (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Signature (â links)
- Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 - (â links)
- Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8 (â links)
- Reference:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 - (â links)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (5) ; (b) (7) ; (b) (8) (â links)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.70 (â links)
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.3.7 (â links)