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- Document:FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025 + (Official recommendation)
- Document:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024 + (Official recommendation)
- Document:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025 + (Official recommendation)
- Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 + (Official recommendation)
- Document:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 + (Official recommendation)
- Document:GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021 + (Official recommendation)
- Document:GBR HRA - Ending your project 28-Jan-2025 + (Official recommendation)
- Document:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 + (Official recommendation)
- Document:GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021 + (Official recommendation)
- Document:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 + (Official recommendation)
- Document:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) + (Official recommendation)
- Document:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 + (Official recommendation)
- Document:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 + (Official recommendation)
- Document:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 + (Official recommendation)
- Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 + (Official recommendation)
- Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 + (Official recommendation)
- Document:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 + (Official recommendation)
- Document:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 + (Official recommendation)
- Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 + (Official recommendation)
- Document:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 + (Official recommendation)
- 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 PrĂĽfung-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)