Additional Links
Internal Links
External Links
Clinical Trials Information
- ClinicalTrials.gov: ClinicalTrials.gov provides regularly updated information about
federally and privately supported clinical research in human
volunteers. ClinicalTrials.gov gives the public information about a
trial's purpose, who may participate, locations, and phone numbers for
more details.
- CenterWatch: This site focuses on industry supported trials and contains a wealth
of information about clinical research, including listings of more
than 41,000 active industry and government-sponsored clinical trials,
as well as new drug therapies in research and those recently approved
by the FDA. This site is designed to be an open resource for patients
interested in participating in clinical trials and for research
professionals.
- Reporting Guidelines for Adverse Events: Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Includes
adverse event information applicable to all clinical trials regardless
of chronicity or modality.
FDA Links
- The Food and Drug Administration (FDA): The FDA is responsible for protecting the public health by assuring
the safety, efficacy, and security of human and veterinary drugs,
biological products, medical devices, our nation’s food supply,
cosmetics, and products that emit radiation. The FDA is also responsible
for advancing the public health by helping to speed innovations that
make medicines and foods more effective, safer, and more affordable;
and helping the public get the accurate, science-based information
they need to use medicines and foods to improve their health.
- FDA Operations: FDA inspections of Institutional review boards, clinical
investigators, and clinical investigator regulatory sanctions. This
site also includes information on audits/inspections.
HIPAA
- Office for Civil Rights – HIPAA: Medical Privacy - National Standards to Protect the Privacy
of Personal Health Information Office of the Secretary; Standards for
Privacy of Individually Identifiable Health Information; Proposed Rule
[HIPAA; 45 CFR Parts 160 and 164]
Informed Consent
- MedicineNet.com: MedicineNet is a network of U.S. Board Certified Physicians and
Allied Health Professionals. This site is a good source for
easy-to-understand descriptions of medical terminology and medical
information.
Investigational Drugs
NIH Links
- National Institutes of Health: Health information (resources, clinical trials, drug information);
grant and funding opportunities; scientific resources; and NIH
institutions, centers and offices.
- NIH Guidance on Adverse Events Reporting: NIH guidance on reporting adverse events to institutional review
boards for NIH-supported multicenter clinical trials. Release date:
June 11, 1999
- NIH guidelines on inclusion of women and minorities as subjects in clinical research: Notice: OD-00-048, August 2, 2000
- National Library of Medicine: The National Library of Medicine (NLM), on the campus of the National
Institutes of Health in Bethesda, Maryland, is the world's largest
medical library. The Library collects materials in all areas of
biomedicine and health care, as well as works on biomedical aspects of
technology, the humanities, and the physical, life, and social
sciences. The collections stand at more than 7 million items—books,
journals, technical reports, manuscripts, microfilms, photographs, and
images.
Research Subject Guidelines
- Guidelines for the conduct of research involving human subjects at the NIH
- Office of Research Integrity: The
Office of Research Integrity (ORI) oversees and directs Public Health
Service (PHS) research integrity activities on behalf of the
Secretary of Health and Human Services with the exception of the
regulatory research integrity activities of the Food and Drug
Administration. Organizationally, ORI is located within the Office of
Public Health and Science (OPHS) within Office of the Secretary of
Health and Human Services (OS).
- Public Responsibility in Medicine & Research (PRIM&R): PRIM&R is dedicated to creating, implementing, and advancing the
highest ethical standards in the conduct of research. PRIM&R's
conferences, educational programs, and training resources serve the
full array of individuals and organizations involved in biomedical and
behavioral/social science research.
Regulatory Links
- U.S. Department of Health & Human Services (DHHS): DHHS is the United States government's principal agency for
protecting the health of all Americans and providing essential human
services, especially for those who are least able to help
themselves. The department includes more than 300 programs, covering a
wide spectrum of activities.
- Regsource Clinical Investigator’s Page: This
site organizes worldwide regulatory, clinical, toxicological, CMC,
and other drug/device development-related information on the
Internet. This site also includes include complete European Regulatory
coverage as well as extensive Clinical Research information.
- Western Institutional Review Board (WIRB): The WIRB is the oldest and most experienced independent IRB in
America. The University of Rochester is currently using this IRB in
many industry-sponsored protocols.
- National Center for Research Resources (NCRR): The NCRR is a component of the National Institutes of Health. NCRR
supports primary research to create and develop critical resources,
models, and technologies. This site contains information on research
funding opportunities, access to scientific resources and publications,
plans, and other reports.
- Office for Human Research Protections (OHRP): The Office for Human Research Protections (OHRP) provides leadership
and implements a program of compliance oversight for DHHS regulations
for the protection of human. This site includes: IRB regulations and
assurances; regulations and policy guidance (Belmont Report, 45 CFR
46); compliance and educational resources; and international issues
(ethical codes, regulatory standards).
Other specific links located under individual navigation component topics (for example, Data Safety Monitoring links) will be found under Research Subject Advocates component.
NIH Funding Acknowledgement ** Important ** All publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH FUNDING ACKNOWLEDGEMENT and must comply with the NIH Public Access Policy.
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