VIII.A.1. Terminology

Date at which a study commences: date of the start of data collection.

Start of data collection: the date from which information on the first study subject is first recorded in the study dataset or, in the case of secondary use of data, the date from which data extraction starts [IR Art 37(1)]. Simple counts in a database to support the development of the study protocol, for example, to inform the sample size and statistical precision of the study, are not part of this definition.

End of data collection: the date from which the analytical dataset is completely available [IR Art 37(2)].

Analytical dataset: the minimum set of data required to perform the statistical analyses leading to the results for the primary objective(s) of the study.

Substantial amendment to the study protocol: amendment to the protocol likely to have an impact on the safety, physical or mental well-being of the study participants or that may affect the study results and their interpretation, such as changes to the primary or secondary objectives of the study, the study population, the sample size, the study design, the data sources, the method of data collection, the definitions of the main exposure, outcome and confounding variables or the statistical analytical plan as described in the study protocol.