CHAPTER VIII

Post-authorisation safety studies

Definitions
Article 37
For the purposes of this chapter, the following definitions shall apply:
1. ‘Start of data collection’ means the date from which information on the first study subject is first recorded in the study dataset or, in the case of the secondary use of data, the date from which data extraction starts;
2. ‘End of data collection’ means the date from which the analytical dataset is completely available.
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)