Common use of Biometrics Clause in Contracts

Biometrics. Statistical Analysis Plan Omnicare CR will develop a statistical analysis plan, including operational definition of endpoints to be analysed, definition of patient subsets (evaluable and intent-to-treat), visit windows, rules for data handling, and a detailed description of statistical methodology. If Sponsor has a standard statistical analysis plan template then this can be used instead. Omnicare CR has budgeted for one Sponsor review and one revision. Design of Table Shells (Mocks) The statistical plan will include a set of formatted shells for all data displays (data listings, summary tables and graphics) planned for each study. If formatted data displays are not required, a detailed table of contents of SAS generated data displays will be included.

Biometrics. Statistical Analysis Plan Omnicare CR will develop a statistical analysis plan, including operational definition of endpoints to be analysed, definition of patient subsets (evaluable and intent-to-treat), visit windows, rules for data handling, handling and a detailed description of statistical methodology. If Sponsor has a standard statistical analysis plan template then this can be used instead. Omnicare CR has budgeted for one Sponsor review and one revision. Design of Table Shells (Mocks) The statistical plan will include a set of formatted shells for all data displays (data listings, summary tables and graphics) planned for each study. If formatted data displays are not required, a detailed table of contents of SAS generated data displays will be included.