DolPHIN 2 Blog

The External Monitor: The eyes and ears of the Sponsor!

From: Angela Colbers - External Trial Monitor

Published on January 25, 2018 14:25

Let me introduce myself first: I am Angela Colbers, working as a research assistant and post-doc at the Department of Pharmacy of the Radboud University Medical Center (in Nijmegen, the Netherlands). One of my various tasks is monitoring of clinical trials. I do this internally for several studies for which we are the sponsor. For DolPHIN 2 I am appointed as external monitor by the University of Liverpool. Here, I would like to explain a little about the purpose and importance of monitoring when conducting a clinical trial, and about my approach to monitoring of the DolPHIN 2 trial in particular. 

What is the purpose of monitoring in a clinical trial? 

Monitoring has been implemented for the protection of human subjects (the participants within a clinical trial) and to ensure that studies are conducted to high standards of quality. This is important for the safety of participants in the study, for the quality of the study itself, but also for ...

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The DolPHIN 2 Site Initiation Visits

From: Catriona Wait - Principal Investigator

Published on November 29, 2017 17:31

On the 11th to 13th October 2017, we undertook the Site Initiation Visit (SIV) for the DolPHIN-2 study in Kampala, Uganda.  Shortly after, the SIV in Cape Town, South Africa also took place. The SIV is a time when all members of the team – including senior investigators, pharmacists, lab runners, laboratory workers, study nurses and physicians, drivers, regulatory officers and collaborating clinical specialists – come together for training on the protocol, study procedures and any other specific process that are necessary for that study.

The SIV is a very important time for the study team. Up to this point, there have been many months of preparation – discussion, protocol writing, ethical submissions, obtaining regulatory approvals and work on specific aspects of the project. However the SIV brings the whole team together for a focussed discussion regarding the specific details of the study. Whenever I attend an SIV, I feel the protocol really c...

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