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Yaimarelis Saumell N�?¡poles
Posters-Accepted Abstracts: J Clin Trials
Drug safety is investigated during different phases of clinical development, aimed to establish a risk-benefit ratio that allows
registration and marketing. The management of drug safety during the conduct of clinical trials is considered a key to
success and for the overall results of the pharmaceutical company that sponsors the product under study process; which has,
among its strategic goals, registration and subsequent marketing of its products, based on the efficient collection of reliable
data on efficacy and safety. This work constitutes the first stage of a project to implement a safety information management
system of our pharmaceutical company. Starting with criteria of structure, process and outcome; 23 indicators with their
respective standards were identified. From these, 9 instruments were designed and validated, to assess the management of
safety information which is generated at the sites of research, where clinical trials with Molecular Immunology´s Center
products are conducted. The feasibility, internal consistency, and content validity of the instruments were investigated.
Assessment was based on statistical methods. As results, the 9 instruments are feasible to use, that produced low missing data.
Cronbach’salpha coefficient ranged from 0.79 to 0.89 for all of them. The 9 instruments showed good psychometric properties
thus, are reliable tools for examining drug safety management during the conduct of clinical trials.