Selected Links

General Information	UW and Affiliated Research Centers Regulatory Agencies and Information
Resources for Clinical Research	UW offices that will help you get started NIH Awards that support clinical research Major granting organizations that focus on clinical research Demographics Good Clinical Practice (GCP)
Nutrition	General Information Obesity
Gene and Cell Therapy	General Information
For Study Participants	Information about clinical trials Information about specific diseases and conditions Local research studies seeking volunteers
Subject Safety	Local Resources NIH Institutes with Institutional Data Saftey Monitoring Plans (DSMPs)

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General Information
UW and Affiliated Research Centers	UW Medicine Children's Hospital and Regional Medical Center Fred Hutchinson Cancer Research Center
Regulatory Agencies and Information	Office of Research Integrity (ORI) Office for Human Research Protections (OHRP) Federal Drug Administration -- make sure to check out the FDA Warning Letters RegSource (Resources for global regulatory and other product development information) Health Information Privacy and Accountability Act (HIPAA) International Committee on Harmonization NIH Office of Biotechnology Activities
Resources for Clinical Research
UW offices that will help you get started	Office of Clinical Research -- check out their Clinical Trials Administrative Start-up Handbook Research Funding Service
NIH Awards that support clinical research	NIH Career Development Awards K23 Awards NIH Guide for Grants and Contracts
Major granting organizations that focus on clinical research	NIH Roadmap National Center For Research Resources (NCRR, the division of NIH that funds the GCRC) Department of Defense Congressionally Directed Medical Research Programs American Heart Association And if that's not enough... check GrantsNet - Directory for funds for training The Society for Medical Decision Making has an annotated list of funding agencies
Demographics Click here to visit the GCRC's Demographics page	National Population Demographics, 2000 Census (for studies on healthy subjects) Disease-Specific Demographics - This collection of statistics was created for U. Iowa's GCRC. Check it out for the national demographics on a very wide variety of diseases. Statistic sources are included. NIH Office of Extramural Research: Policies on Inclusion of Women and Minorities as Participants in Research Involving Human Subjects US Census 2000 Overview of Race and Hispanic Origin
Good Clinical Practice Click here to visit the GCRC's GCP pages	Online GCP Training and Certification — This free web-based training program carries both Continuing Medical Education (CME) and Continuing Nursing Education (CNE) accreditation. At the GCRC, we strongly recommend this course for documentation and training of your clinical research team. GCP in FDA-Regulated Clinical Trials World Health Organization GCP Guidelines National Institute of Allergy and Infectious Diseases (NIAID): Selected GCP Regulations & Guidelines
Nutrition
General Nutrition Click here to visit the GCRC's Nutrition Research Core & Body Composition Laboratory	American Dietetic Association USDA Nutrient Database Food and Nutrition Information Center Dietary Guidelines for Americans, 2005 USDA Food Guide Pyramid National Health and Nutrition Examination Survey (NHANES) CDC Growth Charts (United States)
Obesity	NHLBI Obesity Education Initiative (Body Mass Index Calculator) Shape Up America (Body Mass Index table)
Gene and Cell Therapy
General Information Click here to visit the GCRC's cGMP Gene and Cell Therapy Core Laboratory	Gene therapy and the FDA FDA guidance documents for Investigational New Drug (IND) applications. Includes links to download application forms. FDA's new Current Good Manufacturing Practice document FDA Q&A on regulations concerning gene & cell based products (21CFR 1271) UW institutional research biosafety assessment form (research project hazard assessment)
For Study Participants
Information about clinical trials	Clinical Trials FAQ from the National Institutes of Health Clinical Center Clinical Trials FAQ from National Institutes of Health Office of Rare Diseases Clinical Trials and Insurance Coverage - A Resource Guide developed by the National Cancer Institute
Information about specific diseases and conditions	NIH Health Information Index ClinicalTrials.gov Medlineplus Office of Rare Diseases
Local research studies seeking volunteers	UW research studies seeking volunteers (studies seeking healthy volunteers; studies investigating specific diseases or conditions) Fred Hutchinson/UW Cancer Research Consortium
Subject Safety
Local Resources Click here to visit the GCRC's Research Subject Advocacy Program	UW Human Subjects Division CHRMC Institutional Review Board FHCRC Institutional Review Board For national resources, including HIPAA, see "Regulatory Agencies & Information" links above
NIH Institutes with Institutional Data Safety Monitoring Plans (DSMPs) Click here to visit the GCRC's DSMP pages	National Cancer Institute National Institute of Arthritis and Musculoskeletal and Skin Diseases General Monitoring Plan Guidelines for Developing a Monitoring Plan for Studies Requiring a Safety Officer DSMB Charter National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD) Data and Safety Monitoring Policy Plan WITHOUT a DSMB Plan WITH a DSMB National Institute of Mental Health National Institute of Neurological Disorders and Stroke Guidelines for DSMPs