Northwestern Resources

Bluhm Cardiovascular Institute
http://www.heart.nmh.org/ 

Northwestern University Office for the Protection of Research Subjects (OPRS)-Institutional Review Board (IRB)
http://www.northwestern.edu/research/OPRS/irb/index.html

Office of Sponsored Research (OSR)
http://www.northwestern.edu/orsp/index.htm

Office of Research Integrity
http://www.northwestern.edu/research/ori/

Office of Research Safety
http://www.northwestern.edu/research-safety/

Accounting Services for Research and Sponsored Programs (ASRSP)
http://www.northwestern.edu/asrsp

Northwestern Center for Clinical Research
http://www.medschool.northwestern.edu/nccr

Federal Agencies and Resources

Food and Drug Administration
http://www.fda.gov

Office for Human Protections (OHRP)
http://www.hhs.gov/ohrp/
This website provides assurances and IRB registration, education, policy guidance, and workshops.

21 CFR Part 50 - Protection of Human Subjects
http://www.fda.gov/oc/ohrt/irbs/appendixb.html

21 CFR 812 - FDA regulations for Investigational Device
http://www.access.gpo.gov/nara/cfr/waisidx_03/21cfr312_03.html

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION
http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr312_00.html

Good Clinical Practice (GCP) in FDA-Regulated Clinical Trials
http://www.fda.gov/oc/gcp/default.htm
This site provides information concerning Good Clinical Practice (GCP) in the design and conduct of clinical trials. Compliance requirements and resources are included with links to relevant federal regulations and contact persons in the FDA.

http://www.clinicaltrials.gov/
This Website provides patients, family members, and members of the public easy and free access to nationwide information on clinical studies for a wide range of diseases and conditions.