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General Resource

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 Let us also know if you find an outdated or broken link so we may replace it.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). 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/intragenerational

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

Bioethics

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 Clinical Trials and Regulatory Affairs Professionals, please email the URL to clinical@rx.uga.edu. Also, let us also know if you find an outdated or broken link so we may replace it.

Agencies and Institutions

US Food and Drug Administration: www.fda.gov

Department of Health and Human Services (HHS): www.dhhs.gov

The President's Council on Bioethics: www.bioethics.gov

National Institutes of Health (NIH): www.nih.gov

National Reference Center for Bioethics Literature: www.georgetown.edu/research/nrcbl/nrc/index.htm

Howard Hughes Medical Institute: www.hhmi.org

Poynter Center for the Study of Ethics and American Institutions: www.indiana.edu/~poynter

Journals and Periodicals

BioEdge: Weekly newsletter aims to promote ethics in medicine and to provide information and commentary on bioethics. www.bioedge.org

Bioethics.com: Global information source on bioethics news and issues. www.bioethicsnews.com

Bioethics Wire:A service of The Hastings Center, provides commentary on issues in bioethics - patient care, health policy, medical science and research, biotechnology, the beginnings and endings of life, and environment and health. It aims to broaden and deepen the social debates about bioethical issues. www.thehastingscenter.org/BioethicsWire/Default.aspx

Bioethics.net: Provides links to daily news articles and weekly commentary on issues in bioethics, from the American Journal of Bioethics. www.generef.com/biotech.news.html

Bioethics News: The news service sponsored by the biotechnology industry. www.generef.com/biotech.news.html

CNN's ethicsmatters: This site archives CNN columns by Dr. Jeffrey Kahn, University of Minnesota Center for Bioethics.  The most recent information is from 2002 and organized by topic. cnn.com/HEALTH/bioethics/archive.index.html

IRB Forum: This site provides news and information about upcoming events concerning ethical, regulatory, policy concerns about research with humans. www.irbforum.org

MSNBC "Breaking Bioethics": News columns on topical issues by Dr. Arthur Caplan for the University of Pennsylvania. msnbc.msn.com/id/3035344

News in Bioethics and Biotechnology: This site links to journals, books and news. www.eubios.info/NBB.htm

Science and Development Network: News stories about health in the developing world. Search for bioethics. www.scidev.net/dossiers/index.cfm?fuseaction=dossierItem&Dossier=5
SciDev.Net: Distributes news and science and technology aimed toward the developing world. updated weekly and has a section on ethics of research. www.scidev.net/index.cfm?fuseaction=aboutus

Cell Therapy and Biologics

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 Clinical Trials Professionals, please email that url to clinical@rx.uga.edu.

Let us also know if you find an outdated or broken link so we may replace it.


Transfer of Therapeutic Products to CDER: www.fda.gov/cber/transfer/transfer.htm

CBER background information: www.fda.gov/cber/about.htm

CDER Frequently Asked Questions on Drug Development and Investigation - New Drug Applications: www.fda.gov/cder/about/smallbiz/faq.htm

Manual of Standard Operating Procedures and Policies: Regulatory - License Applications: www.fda.gov/cber/regsopp/8405.htm

Overview of Regulations for CDRH: www.fda.gov/cdrh/devadvice/overview.html

Information on Premarket Approval Applications: www.fda.gov/cdrh/pmapage.html

Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval and Applications: www.fda.gov/cdrh/mdufma/guidance/1224.html

Cellular Therapy: Potential Treatment for Heart Disease: www.fda.gov/cber/genetherapy/celltherapyheart.htm

Human Gene Therapy and the role of the Food and Drug Administration: www.fda.gov/cber/infosheets/genezn.htm

Alzheimers: Searching for a Cure: www.fda.gov/fdac/features/2003/403_alz.html

Tissue: www.fda.gov/cber/tiss.htm

Vaccine Product Approval Process: www.fda.gov/cber/vaccine/vacappr.htm

CBER About Us: www.fda.gov/cber/about.htm