Management of safety information from clinical trials : report of CIOMS Working Group VI. 

 - 303p. 
<br/><br/><label>ISBN: </label>9290360798 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Clinical trials--Ethics, standards<br/>Adverse drug reaction reporting systems--Standards, legislation<br/>Product surveillance, Postmarketing--Standards<br/>Data collection--Standards<br/>Safety management--Methods<br/>Risk assessment