Research Administration

Human Subject Research (IRB):
Research Committee Review Web Site Links

FDA

• Food and Drug Administration:
  http://www.fda.gov/default.htm
• Center for Drug Evaluation and Research (CDER)
  http://www.fda.gov/cder/index.html
• IND Information
  http://www.fda.gov/cder/forms/1571-1572-help.html
• IDE Overview

http://www.fda.gov/cdrh/devadvice/ide/index.shtml

• Forms
  http://www.fda.gov/opacom/morechoices/fdaforms/cder.html
• Center for Devices and Radiologic Health (CDRH)
  http://www.fda.gov/cdrh/index.html
• CDRH Referral List
  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfReferral/referral.cfm
• Center for Biologics Evaluation and Research (CBER)
  http://www.fda.gov/cber/index.html
• Guidance by topics
  http://www.fda.gov/cber/guidelines.htm
• Good Clinical Practice
  http://www.fda.gov/cder/guidance/959fnl.pdf

CFRs

• Code of Federal Regulations:
  http://www.access.gpo.gov/nara/cfr/cfr-table-search.html

DHHS-OHRP

• Office of Human Research Protection:
  http://www.hhs.gov/ohrp/policy/index.html
• "OHRP's Draft Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems"
  http://www.hhs.gov/ohrp/requests/com101105.html

ORI

• Office of Research Integrity
  http://ori.dhhs.gov/
  
  

RI STATE REGs

• Rhode Island State Department of Health
  http://www.health.state.ri.us
• RI State Law

MISCELLANEOUS

• Certificates of Confidentiality Kiosk
  http://grants.nih.gov/grants/policy/coc/
• HIPAA Privacy Regulations
  http://www.hipaadvisory.com/regs/index.htm
  http://www.hipaadvisory.com/regs/finalprivacy/512.htm
• Medical Terms Dictionary - MedTerms.com
  http://www.medterms.com/Script/Main/hp.asp
• Society of Clinical Research Associates
  http://www.socra.org
  
  
  

Back