UGA Clinical Trials - Web Resources

Web Resources

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to other regulatory affairs professionals, please email that URL to regaffairs[@] Let us also know if you find an outdated or broken link so we may replace it. Thank you.

Glossary of Terms


Glossary of Clinical Data Interchange Standards Consortium (CDISC) Clinical Research Terms: (published in Applied Clinical Trials Magazine - 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):

Clinical Study Results: Database of worldwide trials results from over 60 companies, created by the Pharmaceutical Research and Manufacturers of America (PhRMA):

International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Clinical Trials portal:

Innovation Today is a project of the Pharmaceutical Research and Manufacturers of America:

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., 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:

NCI provides information on understanding cancer trials, types of cancer, finding trials, resources for researchers, most requested pages, and more:

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:

The Veterans Administration (VA) and NCI provide information on their interagency partnership agreement in clinical trials for cancer:


U.S. Department of Health and Human Services provides information on HIV/AIDS Treatment, Prevention, and Research:

Vision Trials

National Eye Institute (NEI) provides a clinical studies database, vision research information, and 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":

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:

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:

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:

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.

US Government Related Links

US Government Printing Office:
FDA GMP Regulations (CFR21): _01/21cfr211_01.html
The Code of Federal Regulations (CFR):

US Food and Drug Administration:
The Center for Biologics Evaluation and Research (CBER):
CBER Guidelines:

Office of Regulatory Affairs (ORA):

Federal Food, Drug, and Cosmetic Act:
FDA Modernization Act (FDAMA):
Good Guidance Practices (GGP): cfdocs/cfggp/search.cfm
Product Classification Database:

International Program:

Investigation Operation Manual:
Inspection Reference:
The Center for Drug Evaluation and Research (CDER):
cGMP Human Drugs GMP Notes:
The Center for Devices and Radiological Health (CDRH):
Medical Device Reporting Home
Listing Searchable Database:
The Center for Food Safety & Applied Nutrition (CFSAN):
The Center for Veterinary Medicine (CVM):
FDA New Releases:

US Department of Agriculture:
Laws and Regulations:!ut/p/_s.7_0_A/7_0_1OB?navtype=SU&navid=LAWS_REGS

Centers for Disease Control:

Department of Health and Human Services (HHS):

National Institutes of Health (NIH):
National Cancer Institute (NCI):
Journal of the National Cancer Institute:
The National Library of Medicine:
The Visible Human Project:
National Institute of Allergy and Infectious Diseases, National Institutes of Health

National Foundation for Infectious Diseases:

National Science Foundation (NSF):

U.S. Environmental Protection Agency (EPA):

Global Harmonization:

UGA and USG Resource Links

UGA Libraries:
GALILEO: The University System of Georgia electronic database:

UGA College of Pharmacy Millikan Educational Resources Center (M.E.R.C.):

The New England Journal of Medicine:
(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:

The American Medical Association:

The Journal of the American Medical Association:

The New England Journal of Medicine:
(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: or 678-407-5277. You must be a registered student to receive this password.)

Center for Human Simulation:

Development of Polio Vaccines:

DNA Vaccine Information Site:

Epidemic! The World of Infectious Disease:

Molecular Expressions:

The Vaccine Page (from

The National Library of Medicine:
The Visible Human Project:


Scientific Journal Links

BioMed Central:

Blood Cells, Molecules, & Diseases:

British Medical

British Pharmacopoeia:

Doctor's Guide Journal Directory:

Free Medical Journals:

High Wire:

Journal of Biotechnology:

Journal of Infectious Diseases:

Journal of Virology:

MedBioWorld (lists of Bioscience Journals):

Nature Immunology (from Nature Publishing Group):

United States Pharmacopoeia:


International Links

Canada Health, Therapeutic Products Directorate:

EUROPE (UK links will have separate entry)
European Commission's Pharmacos:
EudraLex: The Rules Governing Medicinal Products in the European Union: European Guide to GMP:

The European Medicines Agency:
European Guidelines on Quality, Safety & Efficacy:
Mutual Recognition Agreements:

European Federation of Pharmaceutical Industries & Federations:

European Pharmacopoeia: Mutual Recognition Agreements Status:

ASIA (including Australia)
Japanese Ministry of Health, Labour & Welfare:
Australian Department of Health and Aging:

United Kingdom Department of Health:

UK Medicines and Healthcare Products Regulatory Agency:

World Health Organization:

World Health Organization's Essential Drugs and Medicines Policy:

International Pharmaceutical Federation:

International Pharmaceutical Excipients Council:


Professional Associations and Societies

Society of Clinical Research Associates (SoCRA):

Association of Clinical Trials Professionals:

Society for Clinical Trials:

Society for Clinical Data Management:

Regulatory Affairs Professional Society (RAPS):

AdvaMed (Advanced Medical Technology Association)

Pharmaceutical Research & Manufacturers of America (phRMA):

Pharmaceutical Inspection Cooperation Scheme (GMP Guide & Basic Standards):

PDA, Parenteral Drug Association, an International Association for Pharmaceutical Science and Technology:

Biotechnology Industry Organization (BIO):

The Food and Drug Law Institute (FDLI):

National Foundation for Infectious Diseases:

National Organization for Rare Disorders (NORD):

International Federation of Pharmaceutical Manufacturers Association, (IFPMA):

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH):
ICH Guidelines at the IFPMA site:

The Society for Life Science Professionals:

The Emerging Leaders Network: 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:


International Organization for Standardization:

Weights &


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 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:

Department of Health and Human Services (HHS):

The President's Council on Bioethics:

National Institutes of Health (NIH):

National Reference Center for Bioethics Literature:

Howard Hughes Medical Institute:

Poynter Center for the Study of Ethics and American Institutions:

Journals and Periodicals

BioEdge: Weekly newsletter aims to promote ethics in medicine and to provide information and commentary on bioethics. Global information source on bioethics news and issues.

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. Provides links to daily news articles and weekly commentary on issues in bioethics, from the American Journal of Bioethics.

Bioethics News: The news service sponsored by the biotechnology industry.

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.

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

MSNBC "Breaking Bioethics": News columns on topical issues by Dr. Arthur Caplan for the University of Pennsylvania.

News in Bioethics and Biotechnology: This site links to journals, books and news.

Science and Development Network: News stories about health in the developing world. Search for bioethics.
SciDev.Net: Distributes news and science and technology aimed toward the developing world. updated weekly and has a section on ethics of research.

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

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

Transfer of Therapeutic Products to CDER:

CBER background information:

CDER Frequently Asked Questions on Drug Development and Investigation - New Drug Applications:

Manual of Standard Operating Procedures and Policies: Regulatory - License Applications:

Overview of Regulations for CDRH:

Information on Premarket Approval Applications:

Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval and Applications:

Cellular Therapy: Potential Treatment for Heart Disease:

Human Gene Therapy and the role of the Food and Drug Administration:

Alzheimers: Searching for a Cure:


Vaccine Product Approval Process:

CBER About Us: