Abstract

ARIAS VALENCIA, Samuel Andrés  and  HERNANDEZ PINZO, Giovanna. Study monitoring: a useful tool for quality health research. Rev Panam Salud Publica [online]. 2009, vol.25, n.5, pp. 462-468. ISSN 1020-4989.  http://dx.doi.org/10.1590/S1020-49892009000500013.

As well as protecting the rights of participants, a study's ethics must encompass the quality of its execution. As such, international standards have been established for studies involving human subjects. The objective of this review is to evaluate the usefulness of the Guide to Good Clinical Practice and "study monitoring" as tools useful to producing quality research. The Guide provides scientific ethics and quality standards for designing, conducting, registering, and notifying studies involving human subjects. By implementing specific processes and procedures, study monitoring seeks to ensure that research is followed and evaluated from inception, through execution and closure, thus producing studies with high quality standards.

Keywords : biomedical research; research design; clinical trials; clinical protocols; ethics committees; research; ethical review; human experimentation; research support topic.