Division 10 The information shall at least include:
United Kingdom
- (a)
a valid EU trial number;
- (b)
a sponsor study number;
- (c)
an identifiable coded subject;
- (d)
an identifiable reporter;
- (e)
a SUSAR;
- (f)
a suspect investigational medicinal product (including active substance name-code);
- (g)
a causality assessment.