Data management project team

The level of effort estimates given in Exhibit 4-1 are for time used by the project team. Design time is an estimate of the number of person days that will be needed to develop a fully defined system program/element or management process starting with the data collected during the assessment phase. 

Also, I thank my other colleagues at Merck John Simon, Dr. Yao Wang, Dr. Annie Samuel, Dr. Jay Mehta, James Goggin, Andrew Ferguson, and Marianne Malloy. They were all part of the Merck Chemical Registration System Project Team, and many of them shared invaluable knowledge about compound data management with me. 

The authors gratefully acknowledge financial support from the Netherlands Ministry of Agriculture Nature Management and Fisheries (program no. 390 Safety of food and animal feed ). In addition, the authors thank T. A. Brimner, G. R. Stephenson, and the lUPAC project team for their input of scientific data. 

As with any computer system handling critical data, the choice of supplier is crucial to on-time and in-full delivery of a system meeting both client and regulatory expectations. Key considerations should be the robustness of the supplier s Quality Management System, the caliber of the project team put forward by the supplier, and the supplier s previous experience with similar blood establishment clients/projects. 

Once the project team completes a protocol synopsis, in-house resources should be evaluated. Consideration is given to the type of study required along with the study s priority within the project. The advantages of doing the data management in-house include ... 

From the data management perspective, the clinical data coordinator (CDC) is the central team member receiving and distributing data-related information to the project team members. The CDC meets with the project team members to review the project material collected and to elicit the rules and special requirements from the statistician, clinician, safety officer, medical writer and regulatory associates. These project materials, rules and special requirements will be considered in conjunction with data management requirements to develop the data management plan. The CDC should prepare the following documents before the clinical trials are initiated ... 

Clinical development (phases lib and III) Pharmaceutical development Biostatistics and data management Global project teams... 

From the data management perspective, the clinical data coordinator (CDC) is the central team member receiving and to distributing data-related information to the project team members. The CDC meets with the project team members to review the project material collected and to elicit... 

At the end of the site visits, a project team meeting should be held that summarizes the data collected and the assessment of each site. This assessment wiU give the team insight into its operation, and more than likely they will discover information unknown to management that wUl be useful in developing altematives. 

To achieve this goal, two existing deep mining operations were considered for the application of aramid ropes. Management at these operations has provided the project team with the actual cost and production data as well as hoisting system configurations and parameters. Based on a mix of simulations and estimates, three case studies have been completed. The first two cases refer to mine A and the third case to mine B. This paper summarizes the results obtained from these case studies. 

Maturity levels of information system are presented in Fig. 22.4. At the first level a product data management (PDM) system needs to be introduced. A PDM/PLM system is a meeting point for project team members where all project-related documents are available. At the second level an advanced level of visualisations tools is requested. Clear presentation of components and assemblies with 3D models and viewers is necessary for inter-team communication, especially in a spatially distributed environment. At the advanced level of PLM implementation PDP specific workflows are available for change management and for milestones approval. This level also involves external team members. At the top level the PDP is integrated with other business processes. 

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