Development of a Quality Program for Clinical Research Sites of Brazilian Clinical Research Cancer Network


Wed, Jun 26 11:45AM
W 19


Development of a Quality Program for Clinical Research Sites of Brazilian Clinical Research Cancer Network

Abstract Summary

A systematic review and a documental analysis were performed. The documental analysis was based on the identification and location of the main national and international guidelines regarding clinical research, including Good Clinical Practice of the International Conference on Harmonization (GCP/ICH), European Directive for conducting clinical trial, Document of the Americas and Normative Instruction number 04 from National Sanitary Surveillance Agency (ANVISA) In the systematic review a search was carried out in the databases: Medline (via pubmed), Lilacs, Scopus, Web of Science, CINAHL (via EBSCO) and Science Direct through June 2012. The search strategy was adapted for each database. The set of studies identified was exported from original bases to a reference management program (EndNote X1 version) in order to identify and eliminate duplicate studies. Furthermore, additional materials were recovered by manual search in specific journals (Controlled Clinical Trials, from 2002 to June 2012; Clinical Trials from 2004 to June 2012 and The Monitor from 2007 to June 2012) and reference lists of relevant articles for the systematic review. The selection of studies occurred in two stages: the first stage two reviewers independently assessed the titles and abstracts according to the inclusion and exclusion criteria previously established to identify potentially relevant studies. Disagreements were resolved by consensus. In the second stage, potentially relevant studies were full reading also by two reviewers and their selection for inclusion in the review resulted in the fulfillment of the following eligibility criteria: quality standards for clinical research sites or excellence sites or quality program for clinical research sites. Disagreements were resolved by consensus between reviewers. A standardized form was used for data extraction of the studies included in the review. Two independent reviewers extracted and stored the data in Excel software.The analysis and synthesis of the data were presented in a narrative perspective due to heterogeneity the articles included in the review. Tables and charts were made with categorization of information described in the studies included in the review.

Poster Presenter

Debora Cristina Victorino Azevedo
Quality manager,
Brazilian National Cancer Institute - INCA

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