The activities of the CTRC are closely coordinated with other resources for researchers through the Research Portal at Tufts Clinical and Translational Science Institute (CTSI). Staff is available to assist investigators in the development of grants and protocols, creation of robust and secure data management systems, and in data analyses.
Biostatisticians and epidemiologists at the Portal are available to assist investigators with effective design and analysis of clinical and translational research protocols. The services provided include, but are not limited to, the following:
- Assistance with study design, including recruitment and randomization methods, and impact of patient eligibility criteria
- Assistance with data analytic plans, including sample size and power, issues with missing data, and multivariate analyses
Support for the development of protocols and grants, subject to staff availability, is provided at no charge to investigators affiliated with Tufts.
The analytic staff at the Portal is also available to assist with data analyses, including analysis of survival and longitudinal data, analysis of data from complex designs, investigations of genetic associations, assessment of reliability, and meta-analysis.
The biostatistics/bioinformatics staff members are available to assist investigators with effective start-up and conduct of clinical and translational research protocols, using computer-based protocol tracking and data management. The services provided by the biostatistics/bioinformatics staff include, but are not limited to, the following:
- Assistance with development of effective data collection forms, to improve the accuracy of study data
- Assistance with preparation of detailed operations manuals and quality assurance plans
- Development of computer applications for frequent tracking of patient enrollment and strategies to optimize patient accrual
- Preparation of a data management system that provides protocol monitoring (including visit schedules), participant status information, double data entry, detection of out-of-range data values, logical inconsistencies, data correction with audit trails, data confidentiality, and security and back-up–systems that can be developed as Web-based trials or as client server applications
John L Griffith, Director Design and Data Resource Center
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