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For your approved project to clinical trials, complete the following sections: *1. Project Statement of Work (SOW): A narrative description of products, services, or results to be delivered by the project. 1.1 Business need: Describe your business need here. 1.2 Product scope description: Provide your product scope description here. *This definition is taken from the Glossary of the Project Management Institute, A Guide to the Project Management Body of Knowledge (PMBOK® Guide) – Sixth Edition, Project Management Institute, Inc., 2017. PMBOK is a registered mark of the Project Management Institute, Inc. 1.3 Strategic plan: *2. Business case: a documented economic feasibility study used to establish validity of the benefits of a selected component lacking sufficient definition and that is used as a basis for the authorization of further project management activities. The business case provides the justification for starting a project. It describes the benefits, costs and financial impact(s) of the project. This area provides justification as to why a project is worth the investment. In this section, build out the driving factors behind this project (i.e., market demand, legal compliance, competitive advantage, customer request, etc.). You should explain why the outcome of the project is beneficial for the organization. Describe your business case here. Describe your strategic plan here. *This definition is taken from the Glossary of the Project Management Institute, A Guide to the Project Management Body of Knowledge (PMBOK® Guide) – Sixth Edition, Project Management Institute, Inc., 2017. PMBOK is a registered mark of the Project Management Institute, Inc. *3. Enterprise environmental factors: conditions, not under the immediate control of the team, that influence, constrain, or direct the project, program, or portfolio. Enterprise environmental factors refer to both internal and external factors that surround or influence a project’s success. Enterprise environmental factors may enhance or constrain project management options and may have a positive or negative influence on the outcome. Enterprise environmental factors can vary from government rules to industry standards and organizational culture to market conditions. In this section, address how enterprise environmental factors can affect your project. Will government standards require additional steps to be implemented? Are economic conditions an impediment? Is employee performance a factor? List your enterprise environmental factors here. *4. Organizational process assets: plans, processes, policies, procedures, and knowledge bases that are specific to and used by the performing organization. Organizations come with a wealth of information and records from which to draw. In this section, think about what organizational assets you can include as part of your project. List your organizational process assets here
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