El monitoreo de estudios: una herramienta útil para la investigación de salud con calidad / Study monitoring: a useful tool for quality health research
Rev. panam. salud pública
; 25(5): 462-468, mayo 2009.
Article
in Es
| LILACS
| ID: lil-519395
Responsible library:
BR1.1
ABSTRACT
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.
Key words
Apoyo a la investigación; Biomedical research; Clinical protocols; Clinical trials; Comités de ética en investigación; Ensayos clínicos; Ethical review; Ethics committees; Experimentación humana; Human experimentation; Investigación biomédica; Protocolos clínicos/normas; Proyectos de investigación; Research design; Research support topic; Research; Revisión ética
Full text:
1
Collection:
01-internacional
Database:
LILACS
Main subject:
Health
/
Biomedical Research
Type of study:
Guideline
Aspects:
Ethics
Limits:
Humans
Language:
Es
Journal:
Rev. panam. salud pública
Journal subject:
SAUDE PUBLICA
Year:
2009
Document type:
Article
Affiliation country:
Colombia
Country of publication:
United States