[Study monitoring: a useful tool for quality health research].
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.
Arias Valencia
Samuel Andrés
SA
Instituto Nacional de Cancerología-Grupo Area de Investigaciones, Bogotá, Colombia. sarias@cancer.gov.co
Hernández Pinzón
Giovanna
G
D035843:Biomedical Research / Q000592:standards*; D006262:Health; D006801:Humans; D011786:Quality Control