Data is the foundation of scientific discovery and future research. Consequently, it is important that each Shared Resource generates a good working plan for how to manage data workflow and how to communicate that plan with partners, to ensure that the data remain intact and accessible. The scope of the Shared Resource Data Management Standard Operating Procedure (DMSOP) defines both data governance and data management practices to create a cohesive and specific plan for each shared resource that facilitates data collection, analysis, processing, and sharing. Standard Operating Procedure (SOP) describes the processes to ensure the appropriate collection of clinical research data, transcription of the data to Case Report Forms (CRFs), and the management of the data. This will include in particular ethical and regulatory aspects.
PURPOSE
Efficient and effective research data management is necessary to minimise risk of error. Data management is an integral part of the research process and should be considered in conjunction with development of the full study protocol. Data management involves not only data collection and entry, but also the ongoing management of data, data preparation, analysis and publication, data archiving and destruction. Ideally, a data manager should be consulted in this process, although this may not always be feasible. A minimal requirement for all studies is a Data Management Plan (DMP) to ensure the quality of research data and outputs, integrity and repeatability, appropriate access to data, and appropriate reuse of data for subsequent research and to record the person(s) responsible for various aspects of data management.
RESPONSIBILITY
The personnel responsible for using and implementing this SOP are listed below.
- Chief Investigator (CI)
- Principal Investigator (PI)
- Data Manager (DM)
- Project Manager (PM)
- Project Statistician (PS)
- Bio-informatician (BI)
- Database Specialist (DS)
- System Administrator (SA)
- Quality Assurance (QA) Officer