| 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.