Pages that link to "Glossary:TAG-00246-Inv-hte"

The following pages link to Glossary:TAG-00246-Inv-hte:

Displaying 50 items.

• Glossary (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-001 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - 1.5 Regulatory requirements (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Consultation (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.8 - 4.9 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.60-001 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (4) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart E (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.1 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-002 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-001 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-001 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 65 (← links)
• Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A. (← links)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 9 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-001 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.1 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.60-002 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.100 (← links)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.2 (← links)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 IV. (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.4.2 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.3 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-001 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.11 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.3 (← links)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 31 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section 2.5 No. 17-22 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.10 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.3 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.61 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (a) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.69 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (c) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (2) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5 (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Introduction (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6 (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-003 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (b) (← links)
• Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 6.4 (← links)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.1 - 2.12.3 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.5 – 2.12.9 (← links)