Research Roadmap

A Statistical Analysis Plan (SAP) is a document that describes the statistical procedures and methods to be used to analyse the data resulting from a study in more detail than is usual in a research protocol. Together with the research protocol, establishing the statistical methods in a SAP forms an important foundation for the research methods of a clinical study. Together with the data management plan, the SAP also forms an important assurance element of data integrity.

You are advised to write an SAP as early as possible in the preperation of a study and in any case well before data collection is completed and the database is locked. In a blinded randomized study, investigators must finalize the SAP before the database is locked and before the investigators are unblided to treatment allocation. This makes it clear that the investigators drew up their SAP without prior knowledge of the data.

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

There is also a module about the Statistical Analysis Plan included in the e-learning course Research Data Management, which can be accessed via the Learning Portal (Studytube)  (via Course Offerings > search: RDM