Lorenzo Monteagudo, GeidySuárez Piedra, Mailyn2017-05-252017-05-252016-07https://dspace.uclv.edu.cu/handle/123456789/7723Primary Health Care is a new scenario for conducting oncology clinical trials Cuba. It is necessary to assess the conditions of the institutions of this system, to carry out research in line with international requirements of these studies. It is therefore important to have indicators and validated instruments for evaluating these conditions. This work aims to: Develop indicators and tools for evaluation of oncology Clinical Trials in Primary Health Care in Cuba. Materials and Methods: The study was divided into three stages. The first, aimed at finding scientific evidence, in which a literature review in Spanish and English in PubMed / Medline, SciELO and Google data was performed using the key words: clinical trials, indicators validation and indicators quality until March 2016. In the second stage the development of indicators and their instruments for the collection of information was performed. The third phase involved the validation process indicators and instruments indicators structure by expert consensus using the Delphi methodology and pilot testing. Results: We identified as relevant areas to assess the conduct of oncology Clinical Trials in Primary Health Care: the Ethics Committee for Research, Researcher, the institution and the promoter. The validation process resulted in a list of indicators 30, indicators represented by structure 12, 11 and 7 of process results, which are representative of these areas. Additionally they were developed and validated instruments for collecting information structure indicators. Conclusions: The methodologies used allowed the development and validation of indicators to assess the conduct of oncology EC on the APS, corresponding to the characteristics of the Cuban Health System.esEste documento es Propiedad Patrimonial de la Universidad Central “Marta Abreu” de Las Villas. Los usuarios podrán hacer uso de esta obra bajo la siguiente licencia: Creative Commons: Atribución-No Comercial-Compartir Igual 4.0 LicenseAtención Primaria de SaludEnsayos Clínicos OncológicosSistema Sanitario CubanoAtención Primaria de SaludPrimary Health CareThesis