- provide personnel for recruitment and retention of diverse research participants, and comprehensive data management systems, to support OAIC External Projects. Related Sub-Aims include:
- Provide consulting support for operational aspects of proposal preparation;
- Provide training of investigators and study staff regarding operational tasks;
- Develop, test, and implement new OC methods.
- Collaborate with the REC, PESC, and Biostatistics Cores to facilitate coordinated strategies to develop, implement, and monitor the conduct of Yale OAIC-related studies.
Data Management and Informatics
The Data Management and Informatics Component (DMIC) of the Operations Core provides data services in support of research field operations and data analysis. The DMIC formally organized in 1992 for the first cycle of the Yale Pepper Center, but many of us have been colleagues since the early 1980’s.
The DMIC includes a staff of 13 highly trained and experienced data managers, assistant data managers, information technology specialists and a data entry coordinator. DMIC staff have expertise in SAS, MATLAB, MPlus, STATA, R, Linux-based web technologies, Visual Basic, Oncore, and REDCap. Staff members are familiar with the demands of screening and recruitment for large studies, the need for rapid reproduction of monitoring reports and on-going quality assurance measures.Yale's implementation of REDCap is hosted by DMIC. REDCap-based DMIC systems drive many large, national studies including STRIDE, the largest study ever funded by PCORI. DMIC file storage and database systems are monitored by the Yale Information Security Office (ISO) for compliance with Yale's HIPPA policies. DMIC has formal associations with major research centers at Yale School of Medicine, including the Yale Center for Medical Informatics (YCMI), the Yale Center for Analytic Sciences (YCAS), the Yale Center for Clinical Investigation (YCCI), and the West Haven Veteran's Administration.
The specific goals of the Field Component of the Operations Core are to:
- provide centralized recruitment enrollment, assessment and surveillance services to Yale OAIC studies, including a system to carefully monitor recruitment and retention of minority elders in OAIC projects;
- provide assistance to junior faculty, with special attention to translational researchers, in the development of research protocols involving older adult human subjects and their implementation in the field;
- collaborate with the Data Management and Informatics Component of the Operations Core to ensure uniformity of methods and measurement when appropriate among OAIC studies and to protect the confidentiality of data;
- collaborate with the Biostatistics Core by identifying and addressing real world challenges that affect study design and sample estimation;
- train Field staff in uniform and reliable methods;
- create and advance, through development projects, innovative strategies to overcoming obstacles encountered in studies of multi-factorial geriatric conditions;
- provide assistance to externally funded investigators who wish to increase the participation of older adult participants in their research studies;
- monitor adherence to guidelines and regulations governing involvement of human subjects in OAIC projects
The allocation of resources to this Component produces economies of scale and reduces duplication of effort among Yale Pepper Center studies. Access to a pool of well trained Clinical Nurse Researchers and Research Associates and Assistants facilitates efficient startup of studies, quality data collection, and protection of human subjects and their privacy.