The iron door IIS information technology to improve the safety in clinical trials.

Spain, February 2013.- professionals of the Institute research health (IIS) Puerta de Hierro have developed a system of alerts for clinical trials that arises as a result of the collaboration between the scientific direction, Department of clinical trials and the technologies of information and communication (ICT).

The origin of this tool is to improve the quality of care and safety of patients enrolled in a clinical trial.

To achieve this goal, it is essential that the principal investigator of the trial know any non-planned and threatening incident for the life of the patient before 24 hours of the serious adverse event that has been detected. This system consists of sending an SMS to the principal investigator, or partners, provided that one of their patients go to the emergency room of the Hospital Puerta de Hierro.

In addition, all participants in clinical trials are identified with another color in computer system employing medical personnel who are in the hospital, in this way, contact with these patients will have additional information that brings them to know that they are integrated in a process of this nature.

This programme, implemented in October, has marked a before and an then in rehearsals promoted from the Institute of research Puerta de Hierro, as both in this hospital and others, based the serious adverse event reports when they were aware of it and could take a long time before becoming effective. Says Dr. Mariano Provencio, Scientific Director of the Institute and developer of this project, this is a quality criterion essential committees of safety of clinical trials, health agencies and in general, all that is involved in these investigations. In addition, should take into account that this information about a serious unexpected effect spreads throughout the world, alerting other physicians and enabling effective preventive or therapeutic measures.

On the other hand, this application enables access to the promoters of trials only and exclusively to the medical records of their patients, fact that power comply with the data protection act.

Iron door Institute incorporates an average of 140 clinical trials a year, causing them to live 300 and is expected to extend this application to all trials in a short space of time.