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List of works by Rosemarie D C Bernabe

Availability of post-trial access in clinical trials: a review of clinical trial protocols submitted to the research ethics board of the University of the Philippines Manila

scientific article published on 27 August 2019

Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study

scientific article published in 2022

Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?

scientific article published on 27 October 2020

Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports

scientific article published on 29 October 2018

Informed consent and phase IV non-interventional drug research.

scientific article published on 6 January 2011

Is informed consent necessary for randomized Phase IV 'observational' drug studies?

scientific article published on 29 June 2011

Patient representatives' contributions to the benefit-risk assessment tasks of the European Medicines Agency scientific committees

scientific article

Phase IV non-inferiority trials and additional claims of benefit

scientific article

The fiduciary obligation of the physician-researcher in phase IV trials

scientific article published on 07 February 2014

The risk-benefit task of research ethics committees: an evaluation of current approaches and the need to incorporate decision studies methods

scientific article

The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents

scientific article published on 18 March 2021

What do international ethics guidelines say in terms of the scope of medical research ethics?

scientific article

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