Pages that link to "Template:DocumentData"

The following pages link to Template:DocumentData:

Displaying 50 items.

• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.30 (transclusion) (← links)
• Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m) (transclusion) (← links)
• Reference:USA 45 CFR Part 160 09-Apr-2025 - (transclusion) (← links)
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II (transclusion) (← links)
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4. (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Signature (transclusion) (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Part 1 Article 2 (transclusion) (← links)
• Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 Article 3 Paragraph 10 (transclusion) (← links)
• Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 - (transclusion) (← links)
• Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14 (transclusion) (← links)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8 (transclusion) (← links)
• Reference:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 - (transclusion) (← links)
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (5) ; (b) (7) ; (b) (8) (transclusion) (← links)
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.50 (transclusion) (← links)
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.70 (transclusion) (← links)
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.100 (transclusion) (← links)
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.200 (transclusion) (← links)
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.300 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Case Report Form (CRF) (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Acquisition Tool (DAT) (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.1 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.3 - 4.2.4 (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - case -report form (CRF) (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.6 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 56 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 57 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-001 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Paragraph 3 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-001 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-001 (transclusion) (← links)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.8 (transclusion) (← links)
• Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.50 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.3 - 3.11.4.6 (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - monitor (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - verification (validation) of data (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-001 (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.4 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 48 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 2 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Section 4 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 2 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 4 (transclusion) (← links)
• Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Monitoring (transclusion) (← links)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.3 (transclusion) (← links)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.5 - 6.7 (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (d) (transclusion) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (j) (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6.2 (transclusion) (← links)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI D. (transclusion) (← links)