This paper, recently published on the Italian Journal of Tropical Medicine(Vol 15, N 1-4, 2010), reports on a debate that took place during the 6thEuropean Conference of Tropical Medicine in 2009, on some topics of greatinterest for GlobalHealthTrials.org: is there a global standard for clinicalresearch? Should standards be adapted in developing countries? How toencourage research while preventing the exploitation of vulnerableindividuals or groups? Five "debate questions" where addressed by ProfessorNick White and by Dr. Lumuli Mbonile, and discussed with the moderator(Raffaella Ravinetto) and the audience.

24th January 2011 • 1 comment

An article about a workshop that assessed ethical review and informed consent in vulnerable populations. This article aims to prompt a debate leading to better guiding principles on health research in constrained settings

24th January 2011 • 0 comments

The WHO invite comments on these new guidelines: Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

5th January 2011 • 0 comments

A set of 4 consent templates for clinical trials, interview studies, observation studies and sampling only studies.

29th November 2010 • 32 comments

This article explains how an East Africa Research Group have developed and applied a highly pragmatic an effective monitoring system. This group train research staff to monitor or perform QC on studies and then implement a system of reciprocal monitoring between studies. It is cost effective and works well.

5th November 2010 • 1 comment

An overview on trial registration. Here you can find out why trials need to be registered and what the difference is between all the registries - and how to register your study.

1st November 2010 • 2 comments

This article was written by a researcher from Sri Lanka and presents a very helpful overview on Biomedical Ethics. This article will be helpful to all levels of research staff and others who might want an accessible overview

26th October 2010 • 4 comments

An example of a academic research centre resolving the issue of clinical trial data management Peer reviewed by members of the data management expert committee for this programme.

6th October 2010 • 4 comments

This tool has been designed to help researchers run randomised controlled trials. This is available in both English and Spanish

24th August 2010 • 5 comments

The Trial Protocol Tool: a tool to help researchers to write a high quality protocol for a randomised controlled trial AVAILABLE IN SPANISH AND ENGLISH

10th August 2010 • 6 comments

Global Health Trials is a free open-access collaborative programme. We encourage clinical trials in difficult settings such as those with limited resources. We want to make it easier to conduct better trials and use the expertise and experience that already exisits by sharing best practice.

30th April 2010 • 23 comments

What is the definition of clinical trial monitoring? Who can be a monitor? What are the monitor's roles and responsibilities? Read on for some answers.

2nd February 2010 • 6 comments

An overview of different types of clinical trial oversight committees, including steering committees and data safety monitoring committees.

21st November 2009 • 0 comments

Laboratory data is crucial in ensuring subject safety and determining the effectiveness of an investigational medicinal product. Here are some issues to consider for clinical trial laboratories in resource-poor settings.

21st November 2009 • 3 comments

Coming soon! A paper series on clinical trial design for tropical diseases. Read more here and get involved!

21st November 2009 • 0 comments

Project management ensures that the project does not veer off its intended pathway. This begins in planning, all the way through initiation to completion. Read the full article to learn more.

21st November 2009 • 0 comments

Clinical trial governance encompasses sponsorship, contracts, finance, confidentiality, trial insurance and professional indemnity and scientific and ethical review. You can find guidance and template documents relating to all of these topics throughout GlobalHealthTrials.org or you can contribute your own material to help others.

21st November 2009 • 0 comments

Who should write up the results of the clinical trial? Are there guidelines on what should be included in the paper? This article answers these questions.

21st November 2009 • 0 comments

Ticking the last box: once the trial has ended it is important to ensure correct site closure and archiving of study files.

21st November 2009 • 1 comment

Considerations for pharmacovigilance and safety reporting.

21st November 2009 • 0 comments