The following are links to regulatory bodies, research groups and trade associations that we believe provide useful information relating to clinical research and applicable regulatory standards. It is our intention to continue to expand this site to make it more valuable to those in the clinical research community. If you have suggestions for additional links, please let us know
by E-mail.
Regulatory bodies that provide useful technical standards and guidelines:
Name of Organization: |
Web-domain |
| U.S. Food and Drug Administration (FDA) |
www.fda.gov |
| International Conference on Harmonization (ICH) |
www.ich.org |
|
Trade Associations and industry working groups that provide standards documents on clinical information management, computer validation, and electronic signature/record requirements:
Name of Organization: |
Web-domain |
| Association for Clinical Data Management (ACDM) |
www.acdm.org.uk |
| Clinical Research-Computer Systems Validation Working Party (CR-CSV) |
www.cr-csv.org |
| Society for Clinical Data Management (SCDM) |
www.scdm.org |
| Parenterall Drug Association (PDA) |
www.pda.org |
|
Associations providing training relevant to computing and information management in clinical research:
Name of Organization: |
Web-domain |
| Pharmaceutical Education and Research Institute (PERI) |
www.peri.org |
| Drug Information Association (DIA) |
www.diahome.org |
|
