German

The upstream process of collecting and cleaning data merits particular attention as the value of the statistical analysis is directly related to the quality of the data being analyzed. It is therefore important to recognize systematic error sources at an early stage. Other focal points include ensuring the completeness of data and giving special attention to any and all information used for calculating the primary endpoint variable.

CDISC standards gain in importance and are mandatory for most studies. Taking this into account during database setup and applying CDASH standard facilitates the subsequent processes enormously and improves quality and tracebility.