Useful Links (Regulatory Agencies and Other Sites of Interest)
Center for Drug Evaluation and Research (CDER) Clinical Investigator Information
http://www.fda.gov/cder/about/smallbiz/clinical_investigator.htm
This CDER site for investigators contains important information for the conduct
of FDA-regulated studies.
back to top of page
FDA Home Page
http://www.fda.gov
The FDA home page provides a wealth of information on all aspects of the drug and
device approval processes, including the protection of human subjects.
back to top of page
Food and Drug Administration (FDA) Industry Portal
http://www.fda.gov/oc/industry
This is the "industry portal" Web page, maintained by the FDA. It provides links
to areas of the FDA Web site that are most likely to be of interest to industry.
The links are categorized in a logical and user-friendly format.
back to top of page
Good Clinical Practice in FDA-Regulated Clinical Trials
http://www.fda.gov/oc/gcp/default.htm
This is the official Web site of the FDA division responsible for overseeing Good
Clinical Practice (GCP). GCP is a standard for the design, conduct, performance,
monitoring, auditing, recording, analysis, and reporting of clinical trials. Compliance
with this standard assures that the data and reported results are credible and accurate,
and that the rights, safety, and well-being of trial subjects are protected.
back to top of page
International Conference on Harmonisation (ICH) Home Page
http://www.ich.org/
The International Conference on Harmonisation Web site provides access to all available
guidance issued by the ICH organization.
The ICH Guideline for Good Clinical Practice (E6) is available at this address:
http://www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB
back to top of page
OHRP Site
http://www.hhs.gov/ohrp/policy/index.html
The Web site for the Office for Human Research Protections provides valuable information
and guidance regarding the conduct of research that is federally funded or otherwise
under the jurisdiction of the National Institutes of Health and other federal agencies.
back to top of page
World Medical Association
http://www.wma.net/
The World Medical Association (WMA) is the organization that issued the Declaration
of Helsinki and is responsible for its updates.
back to top of page
World Health Organization
http://www.who.int/ethics/en/
The World Health Organization has a site created to aid persons, both inside and
outside of WHO, who are seeking information about bioethics, including the ethical
aspects of healthcare delivery and planning as well as the ethics of clinical care,
research, and biotechnology.
back to top of page
Children's Hospital Boston interactive Parents' Guide to Medical Research
http://www.bostonchild.vitalconsent.com/bstnchld/index.html
Provides a guide to help parents ask questions and gather information that can help
them decide whether or not to allow their child to participate in research.
back to top of page
Health Canada
http://www.hc-sc.gc.ca/index_e.html
The Health Canada home page.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_frequent_multiple_e.html
A collection of Frequently Asked Questions.
back to top of page
|