Admin-Core-001

University Of South Florida, Tampa FL

Investigators

Linked publications & trials

Abstract

SPECIFIC AIMS The objective of this Data Management and Biostatistics Core is to provide data management and statistical support for all projects under this ICEMR. As this ICEMR will capture a large amount of data/information from different study sites, it requires standard operational procedures (SOPs) to ensure quality and uniformity of the data. In addition, the dataset will need to be stored and maintained safely to provide secure and timely data-sharing among multiple investigators of this Center. The ICEMR also requires extensive biostatistical support to ensure proper study design and accurate statistical analysis. Therefore, this Core aims to set up a Data Management System (DMS) to collect, store, and annotate data generated from different study sites and to allow timely sharing of the data among the collaborating teams. A team of statisticians will collaborate to provide biostatistical support to the four projects. In addition, short courses and workshops are planned to continuously build capacity in data management and biostatistics at all the endemic sites. Aim 1. Develop, implement, and maintain a data management system to manage data captured from the study sites. This Core will provide data management support to the four projects within the ICEMR. The DMS will be developed specifically to collect and manage data at the study sites, and ensure uniformity of the procedures and data quality. Multiple features such as data security, tracking, recording, auditing, and reporting will be incorporated into the DMS. The data management team will supervise and collaborate with the project investigators on the study design, development, and testing of the databases and data management software, and provide training for data management and database maintenance. Aim 2. Provide biostatistical support to the four projects and biostatistical training to investigators at the endemic sites. This Core will provide biostatistical guidance and support for all projects within this ICEMR. Statistical support will be available for the study design, sample size determination and power calculation, and statistical data analysis. In addition, this Core will support bioinformatics and spatial analysis, which are integral to the goals of this ICEMR. The Core Leaders, biostatisticians, and bioinformaticians will serve as key points of contact for the entire spectrum of analytical needs of the ICEMR, ranging from classical epidemiologic analyses to bioinformatics and molecular epidemiology. Dr. Jaranit Kaewkungwal, director of BIOPHICS at Mahidol University (MU) will serve as the Core Leader. He will direct and supervise the development of the DMS and the execution of the data management plan. Dr. Runze Li from Penn State University (PSU) will serve as the Core Co-Leader. He will direct this Core to provide statistical support. Dr. Kaewkungwal and Dr. Li will be assisted by Chief of Logistics and Operation Amnat Khamsiriwatchara at MU. Two on-site biostatisticians, Montida Auayporn at BIOPHICS, MU and Xiaomei Li at Kunming Medical University, will provide statistical support to the projects. Bioinformatic analysis and training will be organized by Dr. Liwang Cui, who has extensive experience in this area. During his visit to Mahidol University as a Senior Fulbright Scholar (2007-2008), he developed the bioinformatics curriculum at the Faculty of Science, MU. As required by the RFA, full-time data managers will be hired at each of the sites and will be supervised by the core leads based at MU and PSU.