Working with MedDRA to imorove data standards

Good Clinical Practice Journal

Volumn 13, Issue 9, 2006, Pages 25-28

  Harrison, Judy ^a   Zhao Wong, Anna ^b  

^a Harrison Clinical Consulting LLC   (United States)

^b NONE

Author keywords

Analysis; Clionical trial; Coding; MedDRA; MedDRA queries; Presentation; Retrieval; Standardised

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CLINICAL STUDY; DATA ANALYSIS; INFORMATION RETRIEVAL; MEDICAL INFORMATION SYSTEM; NOMENCLATURE; STANDARD;

EID: 33748675515     PISSN: 13500961     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (10)

1. European Commission. Detailed guidance on the European database of suspected unexpected serious adverse reactions (EudraVigilance - clinical trial module), April 2004.
2. European Corrunission. The rules governing medicinal products in the European Union, Pharmacovigilance, Vol 9, June, 2004 (www.emea.eu.int/ htms/human/postguidance/q77.htm).
3. S Brosch, F Abbinante. 'Using EudraVigilance for safety reporting', Good Clinical Practice Journal, 12(8), 12(8), pp 15-18, 2005.
4. European Commission. A guideline on summary of product characteristics, October, 2005.
5. US FDA, Department of Health and Human Services. Safety reporting requirements for human drug and biological products; proposed rule, 14 March, 2003.
6. Japanese Ministry of Health, Labour and Welfare notification on MedDRA usage, 25 March, 2004 (www.meddramsso.com/MSSOWeb/evweb/regulatory.htm).
7. ICH Harmonised Tripartite Guideline. The common technical document for the registration of pharmaceuticals for human use: efficacy - M 4 E, July, 2003 (www.emea.eu.int/pdfs/human/ich/288799een.pdf).
8. ICH-endorsed guide for MedDRA users, release 3.6. 'MedDRA Term Selection: Points to Consider', 28 March, 2006.
9. ICH-endorsed guide for MedDRA users, release 1.1. 'MedDRA Data Retrieval and Presentation: Points to Consider', 28 March, 2006.
10. MedDRA Maintenance and Support Services Organization. 'MedDRA Introductory Guide, Version 9.0', March, 2006.