Estabelecimento das condições de armazenamento de amostras biológicas provenientes de estudos clínicos desenvolvidos pelo Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos/Fiocruz

In the last decades there was a significative growthing of clinical trial research conducted in diferents areas in Brazil. Parallel to this growth, there was an ethical and regulatory increase in clinical trials projects, especially regarding storage of biological samples from clinical studies. The Health Nacional Council throught theResolution no441, May 12, 2011 and Ministry of Health throught ordinance no2.201, September, 14, 2011 determined the biological samples storage is Institution or Principal Investigator responsability and should ensure ethical and structural issues of the area where will be stored, to preserve the study partcipant´s rights and information associated to the biological samples. Therefore, the development of well-defined procedures guarantee the samples quality, the study partcipant´s and laboratory results confidentiality. For these reasons, this study aimed to establish the conditions of clinical trials biological samples storage based on literature review of the ethical and legal requirements, defining technical requirements, management system samples, specific standard operating procedures (SOP) to the storage area and preparation the regulation model. For the implementation of this project we performed a study and reading of the rules, laws and guidelines from different countries and evaluate national institutions experience that have a biological sample storage area according to the Brazilian requirements We decided to organize a place where the different clinical trials Biorepositories would be, which was named as Biorepositories Platform. An area with emergency power was intended to support this structure six freezers were acquired and sample management system was developed. All infrastructure has been adapted or planned following the Good Practices of Repositories. Seven SOPs were developed specifically to atend the area activities. A regulation model that follows the legislation has been used every Ethical Comitee submission of a new clinical trial. For the quality assessment risk, we used the tool What If and was necessary the construction of six flow charts which served to the application of the tool to guide the evaluation of activities in the area. As a result of this work, it was established the area structure and regulation and implementation of the management system Biorepositories Platform intended for storage and control of biological samples from clinical studies sponsored by Bio-Manguinhos, as recommended by the resolution rules in effect.