Pages that link to "Template:DocumentData"

The following pages link to Template:DocumentData:

Displaying 50 items.

• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI D. (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.1 - 3.11.4.2 (transclusion) (← links)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4 (transclusion) (← links)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q1.2 (transclusion) (← links)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III - IV. (transclusion) (← links)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III B. 3. (transclusion) (← links)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. (transclusion) (← links)
• Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 11 d) (transclusion) (← links)
• Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 Annex 1 (transclusion) (← links)
• Reference:DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021 - (transclusion) (← links)
• Reference:AUT FAQ - COVID-19 Studien 15-Mar-2021 - (transclusion) (← links)
• Reference:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024 - (transclusion) (← links)
• Reference:GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021 - (transclusion) (← links)
• Reference:GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021 - (transclusion) (← links)
• Reference:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 - (transclusion) (← links)
• Reference:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 System Security (transclusion) (← links)
• Reference:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 Q15 (transclusion) (← links)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Amendment approval (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Protocol Amendment (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Responsibility (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Amendment (transclusion) (← links)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Platform, basket and umbrella trials (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.1 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 13 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 15 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 16 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 17 Paragraph 1-3 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 17 Paragraph 4-5 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 18 Paragraph 1-3 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 19 Paragraph 1 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 19 Paragraph 2-4 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 1-3 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 4-7 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 21 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 22 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 23 Paragraph 1-2 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 23 Paragraph 3-6 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 24 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 75 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 71 (transclusion) (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40c-002 (transclusion) (← links)
• Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 8 (transclusion) (← links)
• Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 9 (transclusion) (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 40 (transclusion) (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 41 (transclusion) (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 42 (transclusion) (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 54 (transclusion) (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 55 (transclusion) (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 59 (transclusion) (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (3) (transclusion) (← links)