Research Roadmap

A Statistical Analysis Plan (SAP) is a document that describes the statistical procedures and methods to be used to analyze the study data. It provides more detailed information than is usually included in a research protocol. Together with the research protocol, the SAP forms an important foundation for the research methods of a study. Together with the data management plan, the SAP also forms an important element in ensuring data integrity.

It is advised to write an SAP as early as possible in the preperation of a study, in any case well before data collection is completed and the database is locked. In a blinded randomized study, the SAP must be finalized before the database is locked and before the researchers are unblided to treatment allocation. This confirms that the SAP was established without prior knowledge of the data.

Biostatisticians and methodologists from the department of Epidemiology and Data Science (EDS) have developed a template for an SAP. If you would like support in writing an SAP, please submit a request on the EDS-Consult Service Portal .

A module about the SAP is also included in the e-learning course Research Data Management, which can be accessed via the Learning Portal (Studytube) (Course Offerings > search: RDM).