A data management plan is a living document that can be used to plan a research project. In addition to the research project, it also describes the type of data that will be generated during the project and the scope and quality of this data. A DMP also states how and where the data will be stored, whether and how it can be reused and where it will be published after the project is completed. Another reason a DMP can also be used to plan a scientific project is because legal aspects and the anonymisation or pseudonymisation of the data are addressed. As a result, problems that would otherwise only arise during the course of the project can be identified when the DMP is created and solutions can be developed in advance.
A study protocol, on the other hand, deals not only with the data generated in the course of a scientific study, but also with the research project as a whole. The study protocol also sets out the state of research on which the study is based. The design of the study as well as the objectives and hypotheses to be tested are also part of a study protocol. Further information that should be recorded in a study protocol include the inclusion and exclusion criteria of a study, the drop-out criteria for test subjects, the statistical evaluation methods or the participating test centres and investigators.
The study protocol contains information that can be helpful in the creation of a DMP, but a study protocol cannot replace a DMP and vice versa.