Código Tipo de Farmaindustria de Protección de Datos personales en el ámbito de la Investigación Clínica y de la Farmacovigilancia / No disponible

El Código Tipo establece criterios uniformes en la aplicación sectorial de la Ley Orgánica de Protección de Datos (LOPD) y en su Reglamento de desarrollo, aumenta las garantías de su cumplimiento y disminuye el nivel de incertidumbre en su implementación. Contempla dos actividades fundamentales en la industria farmacéutica, como son la investigación clínica y la farmacovigilancia, desarrolla todos los escenarios que se llevan a cabo en la práctica diaria de estas actividades y establece tanto procedimentos de utilización de datos personales como de disociación irreversible, eximiendo éstos últimos de la aplicación de la normativa en materia de protección de datos. Desarrolla un protocolo que incluye las directrices a seguir para la atención del ejercicio de los derechos de acceso, rectificación, cancelación y oposición ejercitados por los afectados y prevé las funciones de supervisión de dicho Código por parte del Comité de Seguimiento

The Type Code established uniform criteria in the sectoral application of the Organic La won Data Protection (LOPD) and its implementing Regulation increases the guarantee of its compliance and reduces the level of uncertainty as to its implementation. Two key activities in the pharmaceutical industry are considered, namely clinical research and pharmacovigilance, all scenarios that take place n the daily practice of these activities are developed and procedures for the use of personal data and irreversible dissociation are established, with these last being exempt from the application of data protection legislation. It develops a protocol that includes the guidelines to follow with regard to the exercise of rights of access, rectification, cancellation and opposition exercised by those affected an stipulates the supervisory functions of the Code by the Monitoring Committee

[Type Code of the pharmaceutical industry for the protection of personal data in the field of clinical research and pharmaceutical surveillance]. / Código Tipo de Farmaindustria de Protección de Datos personales en el ámbito de la Investigación Clínica y de la Farmacovigilancia.

The Type Code establishes uniform criteria in the sectoral application of the Organic Law on Data Protection (LOPD) and its implementing Regulation increases the guarantee of its compliance and reduces the level of uncertainty as to its implementation. Two key activities in the pharmaceutical industry are considered, namely clinical research and pharmacovigilance, all scenarios that take place in the daily practice of these activities are developed and procedures for the use of personal data and irreversible dissociation are established, with these last being exempt from the application of data protection legislation. It develops a protocol that includes the guidelines to follow with regard to the exercise of rights of access, rectification, cancellation and opposition exercised by those affected and stipulates the supervisory functions of the Code by the Monitoring Committee.

Quantitative ultrasound of the calcaneus in long-term liver or cardiac transplantation patients.

Bone loss is one of the most common complications after solid-organ transplantation, but it is frequently under-diagnosed. Our purpose was to evaluate quantitative ultrasound of calcaneus (QUS) in comparison with dual-energy X-ray absorptiometry (DXA) to identify transplant recipients with osteoporosis. We have cross-sectionally evaluated 140 transplant recipients (85 liver and 55 cardiac transplantations; mean age: 53.6 years, time since transplantation: 67.9 months). Devices used were Hologic 4500 QDR for DXA measurements and Sahara Clinical Sonometer (Hologic Inc, Bedford, MA) for calcaneal QUS. Quantitative ultrasound index (QUI) was calculated from speed of sound (m/s) and broadband ultrasonic attenuation (dB/MHz). QUI T-score and bone mineral density (BMD) T-score (spine and hip) were obtained from Spanish normative data. According to World Health Organization criteria, defined either at lumbar spine or femoral neck, 61% of the females had osteopenia and 32% had osteoporosis, whereas 52% of the males had osteopenia and 11% had osteoporosis. Calcaneal QUS parameters (speed of sound, broadband ultrasonic attenuation, and QUI) were positively correlated with lumbar and femoral BMD (p<0.001). In receiver operator characteristic analysis, a T-score QUI