Download a copy of the guidelines here:
 |
Guidance for Industry - Safety Reporting Requirements for Clinical Drug Trials (June 2011)
File Size: (186 Kb)
Updated on June 2011 – The amendment includes the use of MedDRA for expedited safety reporting and provides clarification on the reporting requirements for locally unregistered active comparators and compassionate use programmes.
|
User Manual for PRISM Internet Expedited Safety Report Module (version 3.0)
File Size: (718 Kb)
User Manual has been updated on July 2009 to include instructions on using added enhancements.
|
|
Download Adobe Acrobat Reader to view PDF documents.
|
