European Forum for Good Clinical Practice

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Title DOI
https://doi.org/10.3389/fmed.2018.00230 EUPATI and Patients in Medicines Research and Development: Guidance for Patient Involvement in Regulatory Processes
https://doi.org/10.3389/fmed.2018.00270 EUPATI Guidance for Patient Involvement in Medicines Research and Development (R&D); Guidance for Pharmaceutical Industry-Led Medicines R&D
https://doi.org/10.3389/fmed.2018.00231 EUPATI Guidance for Patient Involvement in Medicines Research and Development: Health Technology Assessment
https://doi.org/10.1186/1745-6215-11-104 Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries
https://doi.org/10.3389/fmed.2018.00251 EUPATI and Patients in Medicines Research and Development: Guidance for Patient Involvement in Ethical Review of Clinical Trials
https://doi.org/10.1109/jbhi.2022.3198145 Toward A Regulatory Pathway for the Use of in Silico Trials in the CE Marking of Medical Devices
https://doi.org/10.1007/s12603-013-0340-0 Guidance synthesis. Medical research for and with older people in Europe: Proposed ethical guidance for good clinical practice: Ethical considerations
https://doi.org/10.3389/fphar.2013.00112 A European approach to clinical investigator training
https://doi.org/10.1111/tmi.12734 The Good Clinical Practice guideline and its interpretation – perceptions of clinical trial teams in sub‐Saharan Africa
https://doi.org/10.3389/fmed.2020.585722 Cross-Border Access to Clinical Trials in the EU: Exploratory Study on Needs and Reality
https://doi.org/10.1080/03007995.2024.2308729 Publishing clinical trial results in plain language: a clash of ethical principles?
https://doi.org/10.1016/j.ejogrb.2016.04.004 Position statement from the European Board and College of Obstetrics & Gynaecology (EBCOG)
https://doi.org/10.1258/jrsm.2010.10k010 The Stoke CNEP Saga – did it need to take so long?
https://doi.org/10.1136/jme.2007.021485 How can we provide effective training for research ethics committee members? A European assessment
https://doi.org/10.1016/j.ejogrb.2016.04.016 Position Statement from the European Board and College of Obstetrics & Gynaecology (EBCOG)
https://doi.org/10.1186/1745-6215-13-27 Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries
https://doi.org/10.3389/fmedt.2022.810315 Solving the Evidence Interpretability Crisis in Health Technology Assessment: A Role for Mechanistic Models?
https://doi.org/10.1007/s40290-015-0097-3 Alignment of Competencies to Address Inefficiencies in Medicines Development and Clinical Research: Need for Inter-Professional Education
https://doi.org/10.3389/fmed.2021.795659 The Role of EUPATI CH in Promoting Patient Involvement in Clinical Research: A Multi-Stakeholder Research Project
https://doi.org/10.1186/1745-6215-10-95 Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)
https://doi.org/10.1136/jme.2008.027722 Standards for research ethics committees: purpose, problems and the possibilities of other approaches
https://doi.org/10.1136/medethics-2013-101572 Consensus standards for introductory e-learning courses in human participants research ethics
https://doi.org/10.1177/009286151104500110 Ethical Challenges in Clinical Research at Both Ends of Life
https://doi.org/10.1371/journal.pone.0258093 Using numerical modeling and simulation to assess the ethical burden in clinical trials and how it relates to the proportion of responders in a trial sample
https://doi.org/10.1136/medethics-2011-100064 A syllabus for research ethics committees: training needs and resources in different European countries
https://doi.org/10.1136/bmj.321.7264.777 The ethics of international biomedical research
https://doi.org/10.1136/bmj.323.7307.283 Revised Declaration of Helsinki
https://doi.org/10.1007/s00467-005-2103-6 Developing a European framework for research on children’s medicines: an examination of the proposed EU regulation on medicinal products for paediatric use
https://doi.org/10.1097/00124363-200519010-00007 European Clinical Research Infrastructures Network Meeting Report
https://doi.org/10.2165/00124363-200519010-00007 European Clinical Research Infrastructures Network Meeting Report
https://doi.org/10.2165/00124363-200620030-00004 The EFGCP Annual Conference 2006
https://doi.org/10.1080/13814788.2024.2328707 Series: Public engagement with research. Part 3: Sharing power and building trust through partnering with communities in primary care research
https://doi.org/10.1007/s00103-022-03635-7 Veränderungen durch die neue EU-Verordnung 536/2014 zu klinischen Prüfungen aus Patientensicht
https://doi.org/10.1136/bmj.328.7438.522 New European clinical trials directive
https://doi.org/10.1177/174701610700300309 Communicating with the Elderly: Decision Making and Informed Consent in Subjects with Frailty or Dementia
https://doi.org/10.2165/00124363-200012000-00001 The Declaration of Helsinki: compromise and fallibility
Ethical review committees: local, institutional and international.
https://doi.org/10.1101/2021.01.19.21250091 Using numerical modeling and simulation to assess the ethical burden in clinical trials and how it relates to the proportion of responders in a trial sample
https://doi.org/10.1007/bf03256742 Ethical Issues in the Design of Patient Information Sheets for Research Purposes
https://doi.org/10.2165/00124363-200519010-00006 Developing a European Framework for Research on Children???s Medicines
https://doi.org/10.1097/00124363-200519010-00006 Developing a European Framework for Research on Children???s Medicines
https://doi.org/10.1007/bf03256779 A Reflection on Fraud and Misconduct in Biomedical Research
https://doi.org/10.1002/(sici)1099-1786(1997120)2:4<159::aid-qaj51>3.0.co;2-o Considering quality in ethics: designing QA systems for ethical review and informed consent
https://doi.org/10.1097/00124363-200317010-00005 The Clinical Trial Directive??s Ethical Impact on Research Into Diseases that Cause Incapacity and Diseases of Children
https://doi.org/10.1007/bf03256746 European Forum for Good Clinical Practice Guideline
https://doi.org/10.1177/174701610700300311 Research Ethics Committees in Europe — Living with Diversity
https://doi.org/10.7861/clinmedicine.1-4-325 Ethical approval for health research
https://doi.org/10.21518/1561-5936-2019-5-46-63 Improving and bringing together approaches to education as a factor for the harmonious development of Good Clinical Practice (GCP)
https://doi.org/10.1097/00124363-200012000-00012 Second Meeting of the Global Forum on Bioethics in Research *
https://doi.org/10.1097/00124363-200012000-00001 The Declaration of Helsinki: compromise and fallibility
https://doi.org/10.5281/zenodo.5829365 Report describing toolbox of methodologies and approaches for WPs to engage stakeholders regarding new evidence on the use of medicines in pregnancy and lactation (D6.3)
https://doi.org/10.1200/jco.2024.42.16_suppl.11018 Assessing patient engagement levels in clinical cancer research: Development of a novel evaluation tool and comparison between eastern and western countries.
https://doi.org/10.1016/j.jcpo.2025.100634 Assessing and comparing patient engagement in clinical cancer research: A cross-regional analysis between Europe and Japan using a structured evaluation tool