Roles of conventional steering committee, ARO (including ARO-based steering committee), CRO, and industry sponsor in the design, execution, and reporting of clinical trials
| . | Conventional steering committee . | ARO . | CRO . | Industry sponsor . |
|---|---|---|---|---|
| Design | Protocol development, database review, development of statistical analysis plan for publications | Protocol development, development/review of site training materials,* database review, development of statistical analysis plan for publications and regulatory submission* | Protocol development, development of site training materials, database development, statistical analysis plan development for regulatory submission | Protocol development, statistical analysis plan development and review, interaction with regulatory agencies (in conjunction with the ARO) |
| Execution | Site recommendation, trial progress review, protocol modification, protocol deviation review | Site selection, endpoint quality assurance/review,* safety monitoring,* trial progress review, recruitment/retention strategies, protocol modification, protocol deviation review, endpoint adjudication, statistical analysis plan validation | Site selection, endpoint quality assurance, site training, data management, site monitoring, endpoint adjudication, protocol modification, statistical analysis plan validation | Trial funding, site selection, protocol modifications |
| Reporting | Publications, scientific presentations | Verification of statistical analysis findings and conclusions,* manuscript development, scientific presentation development | Statistical analysis | Statistical analysis |
| . | Conventional steering committee . | ARO . | CRO . | Industry sponsor . |
|---|---|---|---|---|
| Design | Protocol development, database review, development of statistical analysis plan for publications | Protocol development, development/review of site training materials,* database review, development of statistical analysis plan for publications and regulatory submission* | Protocol development, development of site training materials, database development, statistical analysis plan development for regulatory submission | Protocol development, statistical analysis plan development and review, interaction with regulatory agencies (in conjunction with the ARO) |
| Execution | Site recommendation, trial progress review, protocol modification, protocol deviation review | Site selection, endpoint quality assurance/review,* safety monitoring,* trial progress review, recruitment/retention strategies, protocol modification, protocol deviation review, endpoint adjudication, statistical analysis plan validation | Site selection, endpoint quality assurance, site training, data management, site monitoring, endpoint adjudication, protocol modification, statistical analysis plan validation | Trial funding, site selection, protocol modifications |
| Reporting | Publications, scientific presentations | Verification of statistical analysis findings and conclusions,* manuscript development, scientific presentation development | Statistical analysis | Statistical analysis |
Roles unique to the ARO and its associated committees.