1. Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use. Revision 2;European Commission,2006
2. The Medical Dictionary for Regulatory Activities (MedDRA);Brown;Drug Saf,1999
3. ICH Points to consider Working Group. MedDRA® term selection: points to consider. ICH-endorsed guide for MedDRA users: application to adverse drug reactions/adverse events & medical and social history & indications. Release 3.6, based on MedDRA Version 9.0. ICH: MedDRA Documents. 2006. [http://www.ich.org/]. Accessed September 19, 2006.
4. ICH Points to consider Working Group. MedDRA® data retrieval and presentation: points to consider. ICH-endorsed guide for MedDRA users on data output. Release 1.1, based on MedDRA Version 9.0. ICH: MedDRA Documents. 2006. [http://www.ich.org/]. Accessed September 19, 2006.