Pages that link to "Glossary:TAG-00064-Ele-eUn"
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The following pages link to Glossary:TAG-00064-Ele-eUn:
Displaying 14 items.
- Glossary (â links)
- Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 2. (â links)
- Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 III (â links)
- Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV (â links)
- Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - Note (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Electronic data handling (â links)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6) (â links)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.10 (â links)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.30 (â links)
- Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m) (â links)
- Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4. (â links)
- Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14 (â links)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.50 (â links)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.70 (â links)