Analyze Phase Sample Clauses
The Analyze Phase clause defines the initial stage in a project or contractual engagement where the parties assess requirements, objectives, and potential challenges. During this phase, the involved parties typically gather information, review existing processes, and identify key deliverables or issues that need to be addressed before moving forward. This clause ensures that both sides have a clear understanding of the project's scope and expectations, reducing the risk of misunderstandings and setting a solid foundation for subsequent phases.
Analyze Phase. Based on the information collected during the Engage Phase, Mercatus will analyze and document the detailed business requirements of Customer. Once the entire current process has been mapped, Mercatus will identify gaps and overlap within roles or business units and define how Mercatus will fit into and facilitate Customer’s applicable processes using the Platform. This includes definitions and recommendations around: o Data, Document and Entity Management workflows o Commitment Tracking o Reporting and Analytics Dashboards requirements o User roles and access privileges o 3rd party software integration requirements, such as existing monitoring or accounting solutions (if applicable) • This process will be defined within a “Functional Requirements Document” (FRD) delivered by Mercatus, which will be reviewed with the assigned Customer Project Sponsor, then presented to Customer’s Executive Team. This document will be approved in writing prior to the start of the Build Phase to ensure that Customer has complete clarity on what will be implemented, how it will be implemented, and timeline for implementation.
Analyze Phase. [***]
6.2.2.1 Design Hand-off Requirements Document & Checklist reviewed with Customer and minimum dataset identified for Analyze Phase
6.2.2.2 Availability of [***] including all [***].
6.2.2.3 Availability of preliminary [***] covering all modes
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 unde...
Analyze Phase. 16. 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)
17. Medidata will be responsible for completing the Medidata Edge specification templates provided for the study.
18. Customer and Medidata will sign-off on the Medidata Edge specifications prior to starting the study build phase.
Analyze Phase. Requirements gathering session. A requirements-gathering session will be held with Subscriber to ensure that all requirements are understood. Requirements document. A document that describes in detail all of the requirements associated with the workflow. Subscriber representative will be required to sign off on the requirements document before proceeding to the following steps. Application configuration. Ambra Study Uploader. The Ambra Study Uploader will be installed on on-site computers as needed. Please note that the Subscriber will provide the hardware on which the Ambra Study Uploader will be installed. Web Upload Tool. The Ambra Web Uploader will be integrated into the Subscriber’s website for ad hoc uploading as needed. Ambra Gateway installation. The Ambra Gateway will be installed on site as needed. Please note that Subscriber will provide the hardware on which the Gateway will be installed. Alpha review. Initial review with Subscriber in ▇▇▇▇://▇▇▇▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ to familiarize Subscriber’s representatives with the Ambra Applications and workflow in preparation for user acceptance testing. Training material for end users. Ambra will provide training materials in the form of standard Ambra Documentation and up to one hour of edits as requested by Subscriber. User acceptance testing. Subscriber is responsible for all elements of user acceptance testing including test case writing and test case execution. Company will answer any questions as needed.
Analyze Phase. 16. 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)
17. Medidata will be responsible for completing the Medidata Edge specification templates provided for the study.
18. Customer and Medidata will sign-off on the Medidata Edge specifications prior to starting the study build phase. Build ▇▇▇▇▇
▇▇. Medidata will be responsible for configuring the following components of the Rave application: • eCRFs • System edit checks • Standard edit checks • Custom edit checks and custom functions • Standard reports • Standard outputs • Creating user accounts and sites for purposes of development and UAT • Study specific configuration (roles)
20. Medidata will perform quality control activities on all aforementioned components.
21. Medidata will activate the pre-configured standard reports provided with the license of the Rave application.
22. 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. 3.
23. 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
24. Local Labs and associated reference are out of scope under this Statement of Work No. 3.
25. 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 this Statement of Work No. 3. The eCRF will provide file attachment capability to allow lab personnel to attach digitized x-ray image files for ea...
Analyze Phase. Silver Spring Responsibilities. Silver Spring will perform each of the following tasks: