Resources for Clinical Researchers and GCRC Staff

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	Websites for Regulatory Affairs

Federal Websites

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International Regulations

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UF Website

Organizations of interest

Consulting Groups

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Federal Websites: Code of Federal Regulations (CFR): look up engine: Government Printing Office (GPO) Animal Care and Use Regulations Bioethics: Presidents Council DHHS: Belmont Report Human Subject Protection Education Office of Research Integrity Forms NIH: IACUC guidebook Clinical Trials database Office of Biotechnology Activities Reporting Adverse Events Human Lab SAE report Office of Humans Subject Research guidance Office of Human Subjects Research Office of Human Research Protection National Center for Research Resources National Library of Medicine Guidance for NIH Grants Children in research Institutes and Centers list NIH compliance site visits Food and Drug Administration: CBER CBER CBER Guidances CBER IND guide CDER CDER Clinical Investigator Guide Office of Regulatory Affairs Policy Guides Bioresearch Monitoring Compliance Program Manual FDA Information Sheets Forms distribution Dockets Glossary for software development Guidance for IRB Review Laws enforced by FDA Medical Device Reporting for Manufacturers MedWatch MedWatch mandatory reporting form Instructions for MedWatch Computer software interface for MedWatch IATA (US biologics shipping regs) Office for Civil Rights HIPAA OSHA OSHA Format for MSDS sheets of OSHA OSHA Law lookup USDA USDA Rules for USDA return to top State Law: Florida State Florida State Department of Health Statutes (lookup) Public records Chapter 119 Title X return to top International Regulations: EMEA European Agency for Evaluation of Medical Products 2001/20/EC European Center for Parliamentary Research & Documentation European Union regulation lookup EUDRA Annex 1 (regulations for sterile medicinal products) Regulations for pharmaceutics International Conference on Harmonisation ICH Efficacy: E6 Irish Legal Sites Environmental Protection Agency GMO guide Irish Medicines Board Irish Statutes Book Organization for Economic Co-operation and Development OECD Chemical testing UK Gene therapy GLP Medicines Control Act Medicines Control Agency return to top Support: Dell support Microsoft Metric Conversion Google return to top UF Websites: Administrative Affairs Handbook Centers Departments College of Medicine faculty Brain Institute Business Ophthalmology Pathology Pediatrics Division of Sponsored Research Environmental Health and Safety Biologic Safety Manual Directory Disaster Plan IBC: R-DNA registration form E-mail as public records (policy) GCRC Guidance Health Science Center HSC telephone directory IT department Index of parts IACUC at UF InvestiGATOR publications IRBs: new website Logo (Gator graphics and policies for use) Office of Technology Licensing Personnel Policy Human resource forms Infogator On-line training Physical Plant Division Policies for University RGP: Investigator Training Shands CHRIS system return to top Organizations of interest: Agency for Healthcare Research and Quality Alpha One Foundation American Association for Laboratory Animal Science American Society of Gene Therapy American Society of Quality Animal Care and Use page Applied Clinical Trials Association of Clinical Research Professionals Becton-Dickinson on-line (lab supplies) Center for Professional Advancement Cystic Fibrosis Foundation Jackson Laboratories (mice) Med Market (medical "trade show" on-line) Mice & Rats National Academies homepage National Council of University Research Administrators PubMed Regulatory Professional Society Society of Research Administrators United States Pharmacopeia University of Georgia QA return to top Consulting Groups: Axio Research Arkios BioDevelopment International Biologics Consulting Group return to top (Thanks to Aleta Crawford for developing the list.)

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