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Examples/Work Products Research functions Manage regulatory requirements • Adverse event management • FDA reporting for clinical trials Maintain standardization and quality control across sites • Common variable definitions • Common coding structures • Consistent data editing Monitor practice/provider/patient enrollment • Produce study accrual reports Develop and field data collection instruments • Surveys • Interview guides • Abstraction tools • Implementation/process data forms Develop standards for procedures and data definitions • Study-specific SOPs Create and operate a central data management system • Produce analytic data files Perform quality control monitoring of adherence to protocol across all sites • Produce monitoring reports Provide statistical expertise for design and development of research protocols • Develop statistical analysis plans Provide statistical expertise for analysis and publication of study data • Draft analysis and findings sections for scientific reports Develop training materials and conduct training • In person • Web-based/online Identify and contract with special experts or suppliers • Subcontracts Develop and coordinate special panels or committees • Minutes Administrative functions Coordinate project team communication • Set meeting agenda • Schedule meetings Manage study/project documentation • Track study milestones • Manuals of procedures • Decision documentation Centralize storage and distribution of study materials • Materials inventory • Version control Prepare reports for governing and oversight bodies • Evaluation reports • Quarterly reports Support for dissemination • Prepare presentations/posters • Manuscript preparation Assist with OMB packages • Assist PI with completion of application materials FDA, US Food and Drug Administration; OMB, Office of Management and Budgets; PI, primary investigator; SOP, standard operating procedure.
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