GCP information Guidance Documents
ABPI Guideline – Facilities for Non-patient Volunteer Studies
http://www.abpi.org.uk EU Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data
http://europa.eu/legislation_summaries/information_society/l14012_en.htm FDA - Computerized Systems Used in Clinical Trials - Guidance for Industry
http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm135196.htm FDA Bioresearch Monitoring Programs [7348.810/811]
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm160670.htm FDA Code of Federal Regulations
http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=199821 FDA Electronic reading room
http://www.fda.gov/foi/electrr.htm FDA Electronic Records 21 CFR Part11
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11 FDA Financial Disclosure [21 CFR: Part 54]
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54&showFR=1 FDA GCP Inspection Manual
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051363.htm FDA GCP page
http://www.fda.gov/oc/gcp/default.htm FDA IND [21 CFR: Part 312]
7. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312 FDA Informed Consent [21 CFR: Part 50]
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1 FDA Institutional Review Boards [21 CFR: Part 56]
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56&showFR=1 FDA NDA [21 CFR: Part 314]
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-5407.htm FDA Resource page for clinical investigators
http://www.fda.gov/BiologicsBloodVaccines/ResourcesforYou/Industry/default.htm FDA version of ICH GCP now available at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM125880.xls FDA – List of disqualified/restricted clinical investigators
http://www.fda.gov/ICECI/EnforcementActions/DisqualifiedRestrictedAssuranceList/default.htm ICH GCP Guideline (step 5) Topic E6
http://www.ema.europa.eu/pdfs/human/ich/013595en.pdf ICH GCP, ICH Harmonised Tripartite Guidelines for GCP
http://www.ifpma.org/ich5e.html#GCP New ******** (Feb & Mar 2004) Governance arrangements for NHS Research Ethics Committees (REC) -- new SOP for EC, new example consent forms, etc
http://www.corec.org.uk The new Declaration of Helsinki is available at the following address: Please note that this is still new and is actively being considered by the pharmaceutical industry.
15. http://www.wma.net/en/20activities/10ethics/10helsinki/index.html
© 2002 AGCPCRD
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