Resumen

AMADOR GONZALEZ, Rosa Ma et al. Good clinical practices and its use in primary data in adverse events. Rev Ciencias Médicas [online]. 2008, vol.12, n.2, pp.131-138. ISSN 1561-3194.

The good clinical practices are national or international standards for the clinical assays; these practices give credibility and confidence to data given by the stage of the clinical development of the product to be investigated. The adverse event has to be compiled in the primary document with all the characteristics and transcribed to the notebook of data in every subject in the investigation. During the I Clinical Assay, the subject may have symptoms or unfavourable signs with causal relationship with the product or not. Nine clinical records as well as its respective notebooks for data in carriers of the hormone-refractory prosthatic cancer included in the Fase II Clinical assay "Clinical evaluation of the use of the vaccine _chemotherapy _vaccine using the epidermic growing factor in the treatment of these patients were treated in "III Congreso"Pinar del Rio hospital. Statistical analysis methods were used. The most frequent adverse events were: changes in the clinical laboratory tests (100 %), followed by 94% of correspondence in the transcription data of the adverse event into the notebook of data; 94..1% of the events were properly classified and a 92.2% were transcribed properly in the CDR (Revolution Defence Committee).100 per cent of the adverse events had a perception criterion. It is recommended periodical internal monitoring in every CA of the site.

Palabras clave : Clinical Practices; Clinical Assays as an Event; Biomedical Investigation; Investigation Project.

        · resumen en Español     · texto en Español     · Español ( pdf )