Industry Information

Clinical Trials Information:

http://www.clinicaltrials.gov

US Office of Human Subject Research Protections (OHRP):

http://www.hhs.gov/ohrp/about

Clinical Research Standards:

http://www.cc.nih.gov/ccc/clinicalresearch/standards1.html

Convention of Human Rights and Biomedecine – Council of Europe (Spain, April 4, 1997):

http://conventions.coe.int/treaty/en/treaties/html/164.htm

Data Safety Monitoring for Phase I and II Trials:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html

Ethical Conduct for Research Involving Humans – Policies of the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC), Tri-Council Working Group (Canada, 1998):

http://pre.ethics.gc.ca/english/policystatement/introduction.cfm

FDA:

http://www.fda.gov

FDA Regulations Relating to Good Clinical Practice and Clinical Trials:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm114928.htm

FDA Guidance Documents:

http://www.fda.gov/RegulatoryInformation/Guidances/default.htm

Human Subjects Protections, 21 CFR 50:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=50

Investigational Drugs, 21 CFR 312:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312
Subpart D–Responsibilities of Sponsors and Investigators

• 312.50 – General responsibilities of sponsors.
• 312.52 – Transfer of obligations to a contract research organization.
• 312.53 – Selecting investigators and monitors.
• 312.54 – Emergency research under 50.24 of this chapter.
• 312.55 – Informing investigators.
• 312.56 – Review of ongoing investigations.
• 312.57 – Recordkeeping and record retention.
• 312.58 – Inspection of sponsor’s records and reports.
• 312.59 – Disposition of unused supply of investigational drug.
• 312.60 – General responsibilities of investigators.
• 312.61 – Control of the investigational drug.
• 312.62 – Investigator recordkeeping and record retention.
• 312.64 – Investigator reports.
• 312.66 – Assurance of IRB review.
• 312.68 – Inspection of investigator’s records and reports.
• 312.69 – Handling of controlled substances.
• 312.70 – Disqualification of a clinical investigator.

Investigational Devices, 21 CFR 812:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812

Good Clinical Practice Home Page:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance (April 1996):

http://www.fda.gov/RegulatoryInformation/Guidances/ucm122049.htm

Good Clinical Practice: Consolidated Guidance – International Conference on Harmonisation (ICH):

http://www.ich.org/products/guidelines.html

Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products – Geneva, World Health Organization (1995):

http://www.who.int/topics/pharmaceutical_products/en/

National Library of Medicine (NLM):

http://www.nlm.nih.gov/

National Statement on Ethical Conduct in Research Involving Humans – National Health and Medical Research Council (Australia, 1999):

http://www.nhmrc.gov.au/publications/synopses/e35syn.htm

US Office of Human Subjects Research (OHSR):

http://ohsr.od.nih.gov

The Common Rule: 45 CFR Part 46 Protecting Human Subjects:

http://ohsr.od.nih.gov/guidelines/45cfr46.html

Nuremberg Code (from the Nuremberg Military Tribunal, 1947):

http://ohsr.od.nih.gov/guidelines/nuremberg.html

Declaration of Helsinki (World Medical Association, 1964, ’75, ’83, ’89, ’96, 2000):

http://ohsr.od.nih.gov/guidelines/helsinki.html

Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979):

http://ohsr.od.nih.gov/guidelines/belmont.html

Comparison of FDA and HHS Human Subject Protection Regulations:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/EducationalMaterials/ucm112910.htm