Capture and management of safety data is a critical component of the clinical trial (CT) process.  Suhasini Sharma, Chitra Lele and Darshan Bhatt at Sciformix discusses why ensuring safety of clinical trial participants, systematic capture and analysis of safety data from CTs is important for developing the safety profile of the drug and contributing to its benefit-risk assessment which is a key consideration in the approval decision.
http://jforcs.com/jcs/wp-content/uploads/2013/10/Safety-data-management..1.pdf