Clinical Trials -
General Web Resources
Specific topics:
Below are lists of useful web links for course work and professional needs.
If you find a site that you believe would be useful to other regulatory affairs professionals, please email that url to regaffairs@rx.uga.edu. Let us also know if you find an outdated or broken link so we may replace it. Thank you.
Glossary of Terms
NIH-sponsored ClinicalTrials.gov: www.clinicaltrials.gov/ct2/info/glossary
Glossary of Clinical Data Interchange Standards Consortium (CDISC) Clinical Research Terms: (published in Applied Clinical Trials Magazine - www.actmagazine.com): CDISC Clinical Research Glossary (PDF download)
Clinical Trials Resources
U.S. National Institutes of Health (NIH), through its National Library of Medicine (NLM), has developed this site in collaboration with the Food and Drug Administration (FDA): www.clinicaltrials.gov
Clinical Study Results: Database of worldwide trials results from over 60 companies, created by the Pharmaceutical Research and Manufacturers of America (PhRMA): www.clinicalstudyresults.org
International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Clinical Trials portal: clinicaltrials.ifpma.org/no_cache/en/myportal/index.htm
Innovation Today is a project of the Pharmaceutical Research and Manufacturers of America: www.innovation.org
Federal Clinical Trials Programs
Clinical Trials at the National Institutes of Health
NIH Clinical Center in Bethesda, Maryland is the research hospital of the National Institutes of Health (NIH). There, through clinical research, scientific discoveries in the laboratory are translated into new and better medical treatments and therapies for people. www.cc.nih.gov, guides potential participants, their families and physicians about participating in clinical trials in Bethesda, Maryland.
Cancer Trials
The National Cancer Institute (NCI) is the U.S. government's focal point for clinical trials on cancer. Most U.S. government agencies that conduct cancer research, such as DOD or VA, do so in partnership with NCI: www.nci.nih.gov
NCI provides information on understanding cancer trials, types of cancer, finding trials, resources for researchers, most requested pages, and more:
www.cancer.gov/clinical_trials
NCI Clinical Trials Education Series provides publications for individuals and health care professionals to understand clinical trials, such as self-paced workbooks, slide programs on CD-ROM, booklets and videos:
www.nci.nih.gov/clinicaltrials/resources/clinical-trials-education-series
The Veterans Administration (VA) and NCI provide information on their interagency partnership agreement in clinical trials for cancer:
www.va.gov/cancer
HIV/AIDS Trials
U.S. Department of Health and Human Services provides information on HIV/AIDS Treatment, Prevention, and Research: www.aidsinfo.nih.gov
Vision Trials
National Eye Institute (NEI) provides a clinical studies database, vision research information, and resources: www.nei.nih.gov/resources
Mental Health Trials
National Institute of Mental Health (NIMH) supports FAQs for potential participants in mental health research; read "A Participant's Guide to Mental Health Clinical Research":
www.nimh.nih.gov/health/trials/index.shtml
Information on Bioethics
NIH Office of Extramural Research (OER) and the NIH Inter-Institute Bioethics Interest Group provide information on policies and regulations, Institutional Review Board resources, guidance for clinical investigators, research resources, courses and tutorials on bioethical issues in human studies:
www.nih.gov/sigs/bioethics
The National Library of Medicine (NLM) compiled a comprehensive bibliography from 1989 through November 1998, "Ethical Issues in Research Involving Human Participants," compiled by the National Library of Medicine:
www.nlm.nih.gov/archive//20061214/pubs/cbm/hum_exp.html
HHS Office of Human Research Protection (OHRP) provides a guide and training materials on regulations and procedures governing research with human subjects; includes a guidance document on financial relationships in clinical research:
www.hhs.gov/ohrp
Medicare Coverage for Clinical Trials
Centers for Medicare and Medicaid Services (CMS) provides information on the September 19, 2000 final national coverage decision regarding Medicare payments for routine costs and reasonable and necessary items in clinical trials. Read "Medicare Coverage Policy ~ Clinical Trials," based upon the authority found in §1862(a)(1)(E) of the Social Security Act. www.cms.hhs.gov/ClinicalTrialPolicies/Downloads/finalnationalcoverage.pdf
US Government Related Links
US Government Printing Office: www.gpoaccess.gov
FDA GMP Regulations (CFR21): www.access.gpo.gov/nara/cfr/waisidx
_01/21cfr211_01.html
The Code of Federal Regulations (CFR): www.gpoaccess.gov/cfr/index.html
US Food and Drug Administration: www.fda.gov
The Center for Biologics Evaluation and Research (CBER): www.fda.gov/cber
CBER Guidelines:
www.fda.gov/cber/guidelines.htm
Office of Regulatory Affairs (ORA):
www.fda.gov/ora
Federal Food, Drug, and Cosmetic Act: www.fda.gov/opacom/laws/fdcact/fdctoc.htm
FDA Modernization Act (FDAMA): www.fda.gov/cdrh/modact/modern.html
Good Guidance Practices (GGP): www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfggp/search.cfm
Product Classification Database: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD
/classification.cfm
International Program:
www.fda.gov/cdrh/international
Investigation Operation Manual: www.fda.gov/ora/inspect_ref/iom/iomtc.html
Inspection Reference: www.fda.gov/ora/inspect_ref/igs/iglist.html
The Center for Drug Evaluation and Research (CDER): www.fda.gov/cder/index.html
cGMP Human Drugs GMP Notes: www.fda.gov/cder/index.html
The Center for Devices and Radiological Health (CDRH): www.fda.gov/cdrh/index.html
Medical Device Reporting Home Page:www.fda.gov/cdrh/mdr
Listing Searchable Database: www.fda.gov/cdrh/databases.html
The Center for Food Safety & Applied Nutrition (CFSAN): vm.cfsan.fda.gov/list.html
The Center for Veterinary Medicine (CVM): www.fda.gov/cvm/default.html
FDA New Releases: www.fda.gov/opacom/hpnews.html
US Department of Agriculture: www.usda.gov
Laws and Regulations:
www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?navtype=SU&navid=LAWS_REGS
Centers for Disease Control: www.cdc.gov
Department of Health and Human Services (HHS): www.dhhs.gov
National Institutes of Health (NIH): www.nih.gov
National Cancer Institute (NCI): www.nci.nih.gov
Journal of the National Cancer Institute: http://jncicancerspectrum.oupjournals.org
The National Library of Medicine: www.nlm.nih.gov
The Visible Human Project: www.npac.syr.edu/projects/vishuman
National Institute of Allergy and Infectious Diseases, National Institutes
of Health www.niaid.nih.gov
National Foundation for Infectious Diseases: www.nfid.org
National Science Foundation (NSF): www.nsf.gov
U.S. Environmental Protection Agency (EPA): www.epa.gov
Global Harmonization: www.ghtf.org
UGA and USG Resource Links
UGA Libraries: www.libs.uga.edu
GALILEO: The University System of Georgia electronic database: www.galileo.usg.edu
UGA College of Pharmacy Millikan Educational Resources Center (M.E.R.C.):
www.rx.uga.edu/main/home/merc/mercpage
The New England Journal of Medicine: http://content.nejm.org
(Password Protected. You may access this on-line journal using the Galileo Password. This can be retrieved from the UGA Library site (You must be a registered student to receive this password.).
Life Science & Medical Links
Access Excellence, The National Health Museum: www.accessexcellence.org
Vaccines: www.accessexcellence.org/AE/AEC/CC/vaccines_how_why.html
The American Medical Association:
www.ama-assn.org
The Journal of the American Medical Association: http://jama.ama-assn.org
The New England Journal of Medicine: http://content.nejm.org
(Password Protected. You may access this on-line journal using a UGA College
of Pharmacy password. Please contact the Regulatory Affairs Program for
UGA Pharmacy password: regaffairs@rx.uga.edu
or 678-407-5277. You must be a registered student to receive this password.)
Center for Human Simulation: www.uchsc.edu/sm/chs
Development of Polio Vaccines: www.accessexcellence.org/AE/AEC/CC/polio.html
DNA Vaccine Information Site: http://dnavaccine.com
Epidemic! The World of Infectious Disease: www.amnh.org/exhibitions/epidemic
Molecular Expressions: http://micro.magnet.fsu.edu/index.html
The Vaccine Page (from UniScience.net): http://vaccines.org
The National Library of Medicine: www.nlm.nih.gov
The Visible Human Project: www.npac.syr.edu/projects/vishuman
Scientific Journal Links
BioMed Central: www.freemedicaljournals.com
Blood Cells, Molecules, & Diseases: www.elsevier.com/wps/find/journaldescription.cws_home/622796
/description#description
British Medical Journal:www.bmj.com
British Pharmacopoeia: www.pharmacopoeia.org.uk
Doctor's Guide Journal Directory: www.docguide.com
Free Medical Journals: www.freemedicaljournals.com
High Wire: highwire.stanford.edu
Journal of Biotechnology: www.elsevier.com
Journal of Infectious Diseases: www.journals.uchicago.edu/toc/jid/current?cookieSet=1
Journal of Virology: http://jvi.asm.org
MedBioWorld (lists of Bioscience Journals): www.medbioworld.com/bio/journals/bio-journals.html
Nature Immunology (from Nature Publishing Group): www.nature.com/ni
United States Pharmacopoeia: www.usp.org
International Links
CANADA
Canada Health, Therapeutic Products Directorate: www.hc-sc.gc.ca/dhp-mps/index-eng.php
EUROPE (UK links will have separate entry)
European Commission's Pharmacos: ec.europa.eu/enterprise/pharmaceuticals/pharmacos/new_en.htm
EudraLex: The Rules Governing Medicinal Products in the European Union:
ec.europa.eu/enterprise/pharmaceuticals/eudralex/eudralex_en.htm European Guide to GMP: ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol4_en.htm
The European Medicines Agency: www.emea.europa.eu
European Guidelines on Quality, Safety & Efficacy: www.emea.europa.eu/sitemap.htm
Mutual Recognition Agreements: www.emea.europa.eu
European Federation of Pharmaceutical Industries & Federations: www.efpia.org
European Pharmacopoeia: Mutual Recognition Agreements Status: www.pheur.org
ASIA (including Australia)
Japanese Ministry of Health, Labour & Welfare: www.mhlw.go.jp/english
Australian Department of Health and Aging: www.health.gov.au
UNITED KINGDOM
United Kingdom Department of Health: www.dh.gov.uk
UK Medicines and Healthcare Products Regulatory Agency: www.mhra.gov.uk
WORLD
World Health Organization: www.who.int/en
World Health Organization's Essential Drugs and Medicines Policy: www.wpro.who.int/sites/pha/overview.htm
International Pharmaceutical Federation: www.fip.org
International Pharmaceutical Excipients Council: www.ipec.org
Professional Associations and Societies
Society of Clinical Research Associates (SoCRA): www.socra.org
Association of Clinical Trials Professionals: www.acrpnet.org
Society for Clinical Trials: www.sctweb.org
Society for Clinical Data Management: www.scdm.org
Regulatory Affairs Professional Society (RAPS): www.raps.org
AdvaMed (Advanced Medical Technology Association):www.advamed.org
Pharmaceutical Research & Manufacturers of America (phRMA): www.phrma.org
Pharmaceutical Inspection Cooperation Scheme (GMP Guide & Basic Standards): www.picscheme.org
PDA, Parenteral Drug Association, an International Association for Pharmaceutical Science and Technology: www.pda.org
Biotechnology Industry Organization (BIO): www.bio.org
The Food and Drug Law Institute (FDLI): www.fdli.org
National Foundation for Infectious Diseases: www.nfid.org
National Organization for Rare Disorders (NORD): www.rarediseases.org
International Federation of Pharmaceutical Manufacturers Association, (IFPMA): www.ifpma.org
The International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH): www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254
ICH Guidelines at the IFPMA site: www.ich.org/TxtServer.jser?@_ID=250&@_TEMPLATE=272
The Society for Life Science Professionals: www.ispe.org
The Emerging Leaders Network: www.gabio.org/content.aspx?pageid=12 The Emerging Leaders Network (ELN), a division of Georgia Bio (GaBio), is devoted to promoting networking between emerging and established professionals within the Georgia Life Sciences Community. ELN’s programs are designed to facilitate the growth and development of Georgi- based biotechnology academic institutions, industries and service providers.
Additional Reference Sites
Acronym Finder: www.acronymfinder.com
Dictionary: dictionary.reference.com
International Organization for Standardization: www.iso.ch/iso/en/aboutiso/introduction/index.html
Weights & Measures:chemistry.berkeley.edu/links/weights/index.html
