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Clinical Research Program Education Unit

Resources

 

Mass General Research Related Websites

Corporate Sponsored Research and Licensing (CSRL) http://techtransfer.massgeneral.org/

The Harvard Clinical and Translational Science Center (Harvard Catalyst) http://catalyst.harvard.edu/learning.html

HIPAA information for clinical researchers at MGH/BWH http://healthcare.partners.org/phsirb/hrchipaa.htm

Mass General Clinical Research Center (CRC), a Member of the Harvard Catalyst CTSC http://www2.massgeneral.org/crc/

Mass General Clinical Research Directory WIKI http://hub.partners.org/wiki/MGH_Clinical_Research_Directory

Mass General Clinical Research Program http://www.massgeneral.org/crp

Mass General Clinical Research Staff Training Resources WIKI http://hub.partners.org/wiki/MGH_Clinical_Research_Staff_Training_Resources

Mass General HIPAA site - general information on HIPAA http://intranet.massgeneral.org/hipaa/default.asp

Mass General Policy and Procedure manuals http://healthcare.partners.org/mgh/policies

Mass General Research Affairs & Grants Management http://mghra.partners.org/

Mass General Research Intranet http://mghresearch.partners.org/

Mass General Treadwell Library Research Resources http://www2.massgeneral.org/library/default.asp

Partners Clinical Research Office (PCRO) http://www.partners.org/pcro

Partners HIPAA site - general information http://intranet.partners.org/finance/hipaa/HIPAA.asp

Partners Human Research Committee http://healthcare.partners.org/phsirb/

Partners Human Research Committee Mandatory Education http://healthcare.partners.org/phsirb/aboutciti.htm

Partners Human Research Quality Improvement Program http://www.partners.org/phsqi/Index.htm

Partners Research Management http://phsresearchintranet.partners.org/PHS_ResearchMgmt/RM_Contacts.asp 

Research Patient Data Registry http://rpdrweb/partners/rpdrinfo/home/overview.htm

Shipping Infectious Substances Class 6.2 IATA/DOT Trainings at Mass General http://intranet.massgeneral.org/ehs/ehs_programs_trainingprogram.htm#2

Infection Control Training Sessions at Mass General http://infectioncontrol.massgeneral.org/icu/

Federal Research Websites

21 CFR 812 Investigational Device Exemption www.access.gpo.gov/nara/cfr/waisidx_00/21cfr812_00.html

21 CFR 312 Investigational New Drug Application www.access.gpo.gov/nara/cfr/waisidx_99/21cfr312_99.html

FDA home page www.fda.gov/

FDA Information Sheets for IRBs and Investigators http://www.fda.gov/oc/ohrt/irbs        

"Good Clinical Practice in FDA-Regulated Clinical Trials." www.fda.gov/oc/gcp/ (This site combines many existing FDA resources into a unified site that will be of interest to clinical research PIs, staff, and others.) 

Health and Human Services  (HHS) www.os.dhhs.gov/  

Information for Clinical Investigators www.fda.gov/cder/about/smallbiz/clinical_investigator.htm (FDA regulated studies)

International Conference on Harmonization (ICH) http://www.fda.gov/cder/guidance/iche6.htm(Good Clinical Practice Guidelines)

National Institutes of Health (NIH) www.nih.gov/

Office of Human Research Protection (OHRP) www.hhs.gov/ohrp/