Research Design, Compliance, and Data Management Core (RDCD)

University Of Puerto Rico Med Sciences, San Juan PR

Investigators

Abstract

The Research Design, Compliance, and Data Management (RDCD) Core of the Alliance supports sound and reproducible clinical and translational (C&T) research through 1. expert guidance and counsel on study design, data analyses, and reporting; 2. data management, including the collection and curation of clinical and other real-world data for investigators; and 3. research compliance support to assure that all research is conducted ethically and safely. Specific Aims: 1. Provide and expand epidemiological, biomedical informatics, and biostatistics expertise, including support for the design, implementation, clinical and health informatics, data management, and analysis of clinical and translational research projects. Specific Aims: 2. Support the development of community health-centered research and clinical trials using “real world data” focused on diseases and conditions prevalent among the communities we serve. Specific Aims: 3. Establish compliance processes that a) ensure the ethical and responsible conduct of research in all scientific activities and studies supported by the Alliance and b) safeguard data infrastructures and patient/research subject data. The Core has a Data Management Unit, a Research Design and Analysis Unit, and a Compliance Unit. Core activities will create an integrated, streamlined, and more effective process for supporting C&T. Methodology includes A. Review and support all Alliance-supported studies by providing input on study design, methodology, and data analysis; developing standardized forms that support consistency in data entry; and training for clinical researchers, epidemiologists, biostatisticians, data science, clinical informatics, and biomedical informaticians (Aim 1). B. Support the use of existing large databases; promote the use of the Alliance Volunteer Registry database in recruiting eligible participants in clinical trials; promote the use of the growing Alliance clinical research data warehouse (PRC2RDW) in the development of clinical trials (Aim 2). C. Establish and track compliance and monitoring for all Alliance-supported research, including clinical trials, by review and support from a Compliance Unit and Compliance Board; audit of 100% Human Research core supported projects and 10% of all other Alliance-supported studies annually; and establish comprehensive policies and procedures to safeguard all data infrastructure and harmonize with HIPAA requirements and all institutional and NIH policies and procedures.