ArticleRomanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie2020
Ethical review of patient safety and public health in EU clinical trials legislation: impact of COVID-19 pandemic.
Article in Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed.
- Ethical and Regulatory Awareness of Clinical Trials: A Nationwide Cross-Sectional Study from Poland.Therapeutic innovation & regulatory science · 2026Article
- Ethical issues and the role of the ethics committees during COVID-19 research in pandemic era: a focus on an Italian ethics committee.Frontiers in public health · 2025Article
- Digital Biomarkers in Psychiatric Research: Data Protection Qualifications in a Complex Ecosystem.Frontiers in psychiatry · 2022Review
- The Impact of COVID-19 on National Clinical Trials Network Breast Cancer Trials.Current breast cancer reports · 2021Review
- Health data protection and confidentiality in EU BTC legislation: ethical and safety standards.Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologieArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe study considers the ethical review of the European Union (EU) clinical trials (CTs) legislation, namely the Clinical Trials Regulation (CTR) (EU) 2014∕536, the Directive 2001∕20∕EC and the "Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic" (GMCT) (version 3) issued on 28 April 2020 by the European authorities in the field.
backgroundThe Directive 2001∕20∕EC focuses the legal provisions for the conduct of CTs by acknowledging the screening role of the Ethics Committees (ECs) and of the national competent authorities (NCA) in the Member States (MS) to protect the CT subject and the personal data. CONTENT: The present article displays the ethical requirements for conducting, monitoring and reporting of the CTs by raising awareness on the: (i) new conceptual framework of the "clinical trial", "low-intervention clinical trial", "non-interventional study" and "ethics committee"; (ii) ethical considerations addressed in Part I and Part II of the assessment report; (iii) evaluation of the coronavirus disease 2019 (COVID-19) pandemic on the current regulatory framework.
conclusionsThe CTR stimulates the EU clinical research and enables an independent control with regard to the respect of the interests of the CT subject.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.