EthosExcel™ has listed a number of resources found on the internet here for your convenience. We feel these resources can be particularly useful for prospective or current Principal Investigators or those considering a career in clinical research.
Clinical Trials Information:
US Office of Human Subject Research Protections (OHRP):
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:
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):
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):
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: