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The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure
Data management comprises all disciplines related to handling data as a valuable resource, it is the practice of managing an organization's data so it can be analyzed for decision making. [ 1 ] Concept
Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials , clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes.
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.
ODM is a vendor-neutral, platform-independent format for interchange and archive of clinical study data. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information. [8] ODM was first introduced in 1999, and the latest version, 1.3.2, was released in 2012. [9]
A data management plan or DMP is a formal document that outlines how data are to be handled both during a research project, and after the project is completed. [1] The goal of a data management plan is to consider the many aspects of data management, metadata generation, data preservation, and analysis before the project begins; [2] this may lead to data being well-managed in the present ...
WSP USA, formerly Parsons Brinckerhoff, is an American multinational engineering and design firm. [1] The firm operates in the fields of strategic consulting, planning, engineering, construction management, energy, infrastructure and community planning.
Data administration or data resource management is an organizational function working in the areas of information systems and computer science that plans, organizes, describes and controls data resources. Data resources are usually stored in databases under a database management system or other software such as electronic spreadsheets.