Common use of Analyze Phase Clause in Contracts

Analyze Phase. 17. Medidata will provide the following Edge methodology design specification templates in the Medidata formats to Customer: • eCRF specification template • Data validation specification template • Standard output data transfer plan –or- • Custom output data transfer plan specification template (if in scope) • Custom report requirements specification template (if in scope) • Integration specification template including Rave import requirements (if in scope) 18. Medidata will be responsible for completing the Medidata Edge specification templates provided for the study. 19. Customer and Medidata will sign-off on the Medidata Edge specifications prior to starting the study Build phase. Build ▇▇▇▇▇ ▇▇. Training sessions are out of scope under this Statement of Work No. 2, as all sites are identical to the Neodisc US study and will have already have been trained as part of the Neodisc US study implementation. 21. Medidata will be responsible for configuring the following components of the Rave application: • eCRFs (copied from Neodisc US) • System edit checks (copied from Neodisc US) • Standard edit checks (copied from Neodisc US) • Custom edit checks and custom functions (copied from Neodisc US) • Standard reports • Standard outputs (copied from Neodisc US) • Creating user accounts and sites for purposes of development and UAT • Study specific configuration (roles) (copied from Neodisc US) 22. Medidata will perform quality control activities on all aforementioned components. 23. Medidata will activate the pre-configured standard reports provided with the license of the Rave application. 24. Medidata will provide standard outputs for up to one SAS dataset for each unique eCRF. It is assumed that 80 – 90% of the data will be a one-to-one mapping from the eCRF to the SAS data format. Final datasets will be delivered in SAS format. Additional custom output files and transformations can be requested. Additional custom outputs are out-of-scope under this Statement of Work No. 2. 25. Medidata will provide data transfers via a secure FTP site or other secure transfer mechanism at the following frequencies: • 1 test transfer • Twice-weekly transfers, beginning 1 month following Study Start in SAS format • 1 final transfer in SAS format • Additional files and on-demand transfers are out-of-scope • SAS datasets will be provided on a twice-weekly basis, with additional datasets requested and provided on demand 26. Local Labs and associated reference are out of scope under this Statement of Work No. 2. 27. This study will use a Radiographic lab facility. The data will be entered into the eCRF via data entry screens by lab personnel. Automated system integration is outside the scope of these Professional Services assumptions. The eCRF will provide file attachment capability to allow lab personnel to attach digitized x-ray image files for each subject (estimated thirty (30) images per subject with a 3 MB per image file size). The image files will be visible to certain assigned users or user groups and the download of the actual image file will be optional and prefaced by dialog box indicating that the download will not be instantaneous. 28. This study will use the Medidata RAVETM Dictionary Coding module. Customer will provide licenses for any and all dictionaries to be used for auto-coding. 29. Medidata will provide IVRS integration as a copy of IVRS integration from Neodisc US study. 30. Medidata can provide additional system interfaces such as Central Lab, Drug Safety, CTMS, etc if required. These integrations are out-of-scope under this Statement of Work No. 2. 31. The eCRFs and all edit checks will be pushed to UAT and then to production by Medidata all at one time. If edit checks are pushed to UAT and then production on a rolling basis due to out of scope Customer requested changes, additional Project Management costs will be incurred by Customer. Test Phase 32. Medidata will be responsible for testing and quality control of the configured Rave application to the approved specifications as per Medidata Edge methodology for in scope activities for those configuration activities completed solely by Medidata. 33. Customer will be responsible for final UAT of the application including writing and execution of UAT test scripts. 34. Medidata will prioritize with Customer and fix priority issues beyond initial specifications encountered by the UAT testing process.

Analyze Phase. 17. Medidata will provide the following Edge methodology design specification templates in the Medidata formats to Customer: • eCRF specification template • Data validation specification template • Standard output data transfer plan –or- • Custom output data transfer plan specification template (if in scope) • Custom report requirements specification template (if in scope) • Integration specification template including Rave import requirements (if in scope) 18. Medidata will be responsible for completing the Medidata Edge specification templates provided for the study. 19. Customer and Medidata will sign-off on the Medidata Edge specifications prior to starting the study Build phase. Build ▇▇▇▇▇. ▇▇. Training sessions are out of scope under this Statement of Work No. 2, as all sites are identical to the Neodisc US study and will have already have been trained as part of the Neodisc US study implementation. 21. Medidata will be responsible for configuring the following components of the Rave application: • eCRFs (copied from Neodisc US) • System edit checks (copied from Neodisc US) • Standard edit checks (copied from Neodisc US) • Custom edit checks and custom functions (copied from Neodisc US) • Standard reports • Standard outputs (copied from Neodisc US) • Creating user accounts and sites for purposes of development and UAT • Study specific configuration (roles) (copied from Neodisc US) 22. Medidata will perform quality control activities on all aforementioned components. 23. Medidata will activate the pre-configured standard reports provided with the license of the Rave application. 24. Medidata will provide standard outputs for up to one SAS dataset for each unique eCRF. It is assumed that 80 – 90% of the data will be a one-to-one mapping from the eCRF to the SAS data format. Final datasets will be delivered in SAS format. Additional custom output files and transformations can be requested. Additional custom outputs are out-of-scope under this Statement of Work No. 2. 25. Medidata will provide data transfers via a secure FTP site or other secure transfer mechanism at the following frequencies: • 1 test transfer • Twice-weekly transfers, beginning 1 month following Study Start in SAS format • 1 final transfer in SAS format • Additional files and on-demand transfers are out-of-scope • SAS datasets will be provided on a twice-weekly basis, with additional datasets requested and provided on demand 26. Local Labs and associated reference are out of scope under this Statement of Work No. 2. 27. This study will use a Radiographic lab facility. The data will be entered into the eCRF via data entry screens by lab personnel. Automated system integration is outside the scope of these Professional Services assumptions. The eCRF will provide file attachment capability to allow lab personnel to attach digitized x-ray image files for each subject (estimated thirty (30) images per subject with a 3 MB per image file size). The image files will be visible to certain assigned users or user groups and the download of the actual image file will be optional and prefaced by dialog box indicating that the download will not be instantaneous. 28. This study will use the Medidata RAVETM Dictionary Coding module. Customer will provide licenses for any and all dictionaries to be used for auto-coding. 29. Medidata will provide IVRS integration as a copy of IVRS integration from Neodisc US study. 30. Medidata can provide additional system interfaces such as Central Lab, Drug Safety, CTMS, etc if required. These integrations are out-of-scope under this Statement of Work No. 2. 31. The eCRFs and all edit checks will be pushed to UAT and then to production by Medidata all at one time. If edit checks are pushed to UAT and then production on a rolling basis due to out of scope Customer requested changes, additional Project Management costs will be incurred by Customer. Test Phase. 32. Medidata will be responsible for testing and quality control of the configured Rave application to the approved specifications as per Medidata Edge methodology for in scope activities for those configuration activities completed solely by Medidata. 33. Customer will be responsible for final UAT of the application including writing and execution of UAT test scripts. 34. Medidata will prioritize with Customer and fix priority issues beyond initial specifications encountered by the UAT testing process.