Administrative management of clinical studies in hospitals

Défense de mémoire de Pol Benats

Abstract
In the healthcare domain, new processing techniques and new drugs are being developed continuously in order to make health care evolve for the comfort of patients. These developments also permit to discover better ways to treat
common diseases, but above all, to compete with the more difficult illnesses to eliminate. Clinical studies, as well internal in hospitals as sponsored by pharmaceutical companies or authorities, provide a way to develop such treatments.
Unfortunately, this activity does not benefit yet enough today of the benefits of IT to automate the process of research, and even less used to collect, share and store medical knowledge in the world.
In this report, a software for the monitoring of clinical studies will be presented to computerize the data related to such an activity. It will manage the creation, reading, modification and logical deletion of clinical studies information,
patients being enrolled and examinations to be performed on them.
In addition, the results of researches on the automatic submission of medical data to sponsors of clinical studies will be presented. These studies were based on works provided by the organization CDISC which offers standards, established
to support the acquisition, exchange, submission and archive of clinical research data and metadata.
Keywords : study / clinical trial, CDISC, OP’Study, MIMS, data submission2

Contact : Isabelle Daelman - 4966 - isabelle.daelman@unamur.be
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