Pages that link to "Template:ReferenceData"

The following pages link to Template:ReferenceData:

Displaying 50 items.

• Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - SD (transclusion) (← links)
• Reference:AUT BASG - FAQ 11-Feb-2025 Schwarz (transclusion) (← links)
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 2. (transclusion) (← links)
• Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 III (transclusion) (← links)
• Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV (transclusion) (← links)
• Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - CRF (transclusion) (← links)
• Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - Note (transclusion) (← links)
• Reference:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3 6 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.10 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.3 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Computerised Systems Validation (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.8 (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - validation (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Electronic data handling (transclusion) (← links)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2 (transclusion) (← links)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4 (transclusion) (← links)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA (transclusion) (← links)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT (transclusion) (← links)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6 (transclusion) (← links)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13 (transclusion) (← links)
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6) (transclusion) (← links)
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.10 (transclusion) (← links)
• 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)