Research Operations Area (1)

1- Data flow

Competency Definition: The individual has a full awareness of the database requirements for a trial, including verification and query systems and audit trails, and how this can be achieved practically. This involves applying both practical IT knowledge to create the physical database and theoretical knowledge of the CRF and data analysis plan in order to integrate appropriate requirements and specifications. The individual can programme, test and implement an appropriate data management system, including using various devices for electronic data capture (e.g. PDAs, smartphones). They manage and trouble-shoot the physical infrastructure of the database, as well as the software interface and the data itself. They must also pay attention to aspects of security of data, in particular during data transfer or archiving. 

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Competency Definition: The individual understands the data collection, data entry and verification process. They recognise the importance of accurate and comprehensive source documentation, and of verifying this information before it is entered into the database. They are able to spot issues such as out-of-range values. They coordinate or otherwise participate in the data entry process, ensuring that reported trial data are accurate, complete, and verifiable from source documents. They can coordinate and produce data queries, keeping appropriate records of their findings and resolutions, and raising concerns when necessary. They recognise the need for confidentiality, and understand the relevant guidelines pertaining to this. 

Data may be collected from a range of sources including CRFs or health questionnaires that data collectors should be familiar with and able to appropriately fill in or retrieve information from, e.g. if the data has been directly generated by an electronic source. Collectors may work in the laboratory, or directly at the bedside.

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Competency Definition: The individual manages the data process in the trial; they oversee the flow of data and the specifications for its regular backup and safe storage, in line with ethical requirements and respecting participants’ confidentiality. They operate the data management system (DMS), and execute quality management strategies for the data. They check the timely resolution of database queries, and review reports generated from the databases as required. Data management requires excellent knowledge of the data flow plan, processes and guidelines, and good project management skills.

Expert: Experts may work with other sites to implement data management solutions during multicentre trials, and support the improvement of the data management process when necessary.

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