Good clinical practices and its use in primary data in adverse events

Authors

  • Rosa M. Amador González Especialista de I Grado en Oncología. Instructora en Radiofísica Médica. Diplomada Radioterapia. Facultad de ciencias médicas "Dr. Ernesto Che Guevara de la Serna". Pinar del Río.
  • Teresa Llera Clausell Especialista I Grado Urología. Asistente.
  • Karina Miranda Hernández Lic. en Biología. Coordinadora Provincial de Ensayos Clínicos. Asistente en la Disciplina de Anatomía.
  • Yoryana Ramírez Sánchez Lic. en Enfermería. Coordinadora Provincial de Ensayos Clínicos. Instructora en MGI.
  • Bárbara Iglesias Castillo MsC. Longevidad satisfactoria. Especialista I Grado Oncología.

Abstract

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.

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References

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How to Cite

1.
Amador González RM, Llera Clausell T, Miranda Hernández K, Ramírez Sánchez Y, Iglesias Castillo B. Good clinical practices and its use in primary data in adverse events. Rev Ciencias Médicas [Internet]. 2012 Oct. 25 [cited 2025 Dec. 25];12(2):170-81. Available from: https://revcmpinar.sld.cu/index.php/publicaciones/article/view/445

Issue

Vol. 12 No. 2 (2008)

Section

ORIGINAL ARTICLES

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