21 Summary Tab

The Summary Tab provides an overview of study costs. You can view costs based on individual or all Service Providers, by selecting which ones you want to include above the list of costs.

All fees and costs are displayed in the modeling currency. These values are calculated by converting from each provider's billing rate currency to the modeling currency, using the exchange rates specified on the Plan Overview Tab (or any overrides specified at the Provider level).

Fee Descriptions

Below is a description of the fees included on the Summary Tab.

Fees, Hours, and FTEs

• Startup Fees: This value represents all fees, hours, and FTEs associated with study start-up. It includes all fees associated with the start up of the study from Project Activity Start Date to the First subject enrolled (FSFV).

• Clinical Monitoring Closeout and Site Audit Fees: This value represents all fees associated with the site monitoring, site management, telephone monitoring, query resolution, SAE management, site close outs and clinical compliance audits.

• Data Management: This value represents all fees associated with the database design, data entry data coordination, cleaning the data, database audits and the annual IND update.

• Biostatistics: This value represents all fees associated with Table listings and graphs, randomization procedures, stat and analysis plan, and the interim analysis.

• Project Management / Study Oversight: This value represents all fees associated with the project management of the study from beginning to end.

• Medical Writing / Final Report: This value represents all fees associated with delivering the stat report, draft report, and final report (CSR).

• Other: This value represents all fees associated with other tasks not included any other line item.

• Total Fees: Total of all Fees associated with the study.

• Total Pass-Through Costs: All third-party, pass-through, and miscellaneous costs in the study.

• Total Study Costs: These are a combination of all vendor fees, pass through costs, and Sponsor internal costs.

Dates / Duration

• Project Activity Start Date: This is the date that the study is expected to begin, defined as the date that vendors and/or the sponsor start identifying sites and any vendors start billable activity on the study.

• Study End Date: This is the date by which the study is expected to be complete, defined as the date that all activity stops (usually the date the final report (CSR) is finalized). This does not include any post study follow-up by the sponsor.

• Total Study Duration: This value represents the total expected study duration (in elapsed days), defined as the end date minus the start date.

• Duration of Active Treatment Phase: This value represents the total expected duration of the active treatment phase (in days), defined as the last subject observation (LSLV) minus the First subject Observation (FSFV).

Metrics

• Cost per Completed Subject: This value represents the expected cost per each completed subject. This is calculated as the total study costs divided by the number of subjects expected to complete all scheduled subject visits.

• Number of Subjects/Site/Month: This value represents the average expected number of subjects monitored at each site per month, defined as the total number of subjects divided by the number of months of enrollment divided by the number of investigator sites.