The overall objective of the Data and Statistics Core is to provide program project researchers with coordinated and sophisticated data acquisition methodologies and data quality management services, expert statistical and methodological support, and archiving of research data to facilitate the conduct of project clinical trials. The specific objectives of the Data and Statistics Core are: Objective 1: To provide sophisticated data acquisition systems and data quality management services to ensure the timeliness, completeness, accuracy, uniformity, and security of collected clinical and research data. Objective 2: To provide expert statistical and methodological support forthe design, monitoring, and evaluation of the program project clinical trials. Objective 3: To ensure the integrity, safety and accessibility of electronic data through systematic on-site and off-site data archiving and implementation of a data sharing plan. This core is critical to the successful implementation of the individual trials and will leverage shared resources, methodologies, and personnel to reduce costs and increase efficiency across the program project. Data and statistical services will be provided by highly functioning data management and statistical support centers located in Tororo and Kampala, Uganda, and San Francisco, US. The core will be led by Dr. Edwin Charlebois, co-director of the UCSF CenterforAIDS Prevention Studies, UCSF CAPS Methods Core for Data Quality and Management and director ofthe Makerere University-University of California, San Francisco (MU-UCSF) Kampala Data Management Center, a NIH-approved clinical trials data management center in Kampala.

Public Health Relevance

; The Data and Statistics Core will provide access to multiple proven models of researh and clinical trial data management and best-practices via its well established data management and statistics centers in the US and Uganda, allowing for reduced costs and increased efficiency through shared resources, methods and staff cross-trained on all program project trials.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Program Projects (P01)
Project #
5P01HD059454-07
Application #
8706923
Study Section
Special Emphasis Panel (ZRG1)
Project Start
Project End
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
7
Fiscal Year
2014
Total Cost
Indirect Cost
Name
University of California San Francisco
Department
Type
DUNS #
City
San Francisco
State
CA
Country
United States
Zip Code
94143
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