Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance) (c. 536)

ANNEX III U.K. SAFETY REPORTING

2. REPORTING OF SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS (SUSARS) BY THE SPONSOR TO THE AGENCY IN ACCORDANCE WITH ARTICLE 42 U.K.

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.