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- Document:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 + (Official recommendation)
- Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 + (Official recommendation)
- Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 + (Official recommendation)
- Document:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 + (Official recommendation)
- Document:AUT Question - BASG 11-Feb-2025 + (Other)
- Document:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3 + (Other)
- Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 + (Other)
- Document:WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report + (Other)
- Document:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 + (Other)
- Document:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 + (Other)
- Document:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 + (Other)
- Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble + (Preamble of legal act)
- Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble + (Preamble of legal act)
- Document:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble + (Preamble of legal act)
- Document:AUT LekV – Leit-Ethikkommissions-Verordnung 29-Nov-2024 + (Regulatory requirement)
- Document:DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019 + (Regulatory requirement)
- Document:DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 + (Regulatory requirement)
- Document:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 + (Regulatory requirement)
- Document:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 + (Regulatory requirement)
- Document:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 + (Regulatory requirement)
- Document:DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021 + (Regulatory requirement)
- Document:DEU StrlSchV - Strahlenschutzverordnung 08-Oct-2021 + (Regulatory requirement)
- Document:EU 2011/C 172/01 - CT-3 11-Jun-2011 + (Regulatory requirement)
- Document:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 + (Regulatory requirement)
- Document:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 + (Regulatory requirement)
- Document:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 + (Regulatory requirement)
- Document:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 + (Regulatory requirement)
- Document:GBR NHS: Records Management Code of Practice 07-Aug-2023 + (Regulatory requirement)