2.3. Information for the reporting of SUSARs U.K.
10.The information shall at least include:U.K.
(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.
11.In addition, in order to properly process the report electronically, the following administrative information shall be provided:U.K.
(a)
the sender's (case) safety report unique identifier;
(b)
the receive date of the initial information from the primary source;
(c)
the receipt date of the most recent information;
(d)
the worldwide unique case identification number;
(e)
the sender identifier.