Part 50 – Protection of Human Subjects.
http://www.access.gpo.gov/nara/cfr/waisidx_
01/21cfr50_01.html.
Part 54 – Financial Disclosure by Clinical
Investigators. http://www.access.gpo.gov/nara/
cfr/waisidx_01/21cfr54_01.html.
Part 56 –Institutional Review Boardshttp://
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr
56_01.html.
Part 312 –Investigational New Drug Appli-
cation. http://www.access.gpo.gov/nara/cfr/
waisidx_01/21cfr312_01.html.
Part 314–Applications for FDA Approval to
Market a New Drug. http://www.access.gpo.
gov/nara/cfr/waisidx_01/21cfr 314 _01.html.
Compliance Program Guidance Manuals for FDA
Staff:
Compliance Program 7151.02. FDA Access to
Results of Quality Assurance Program Audits
and Inspections, 1996. [Same as Compliance
Policy guide 130.300.] http://www.fda.gov/
ora/compliance_ref/cpg/cpggenl/cpg130-300.
html.
Compliance Program 7348.001–Bioresearch
Monitoring – In Vivo Bioequivalence, 1999.
http://www.fda.gov/ora/compliance_ref/bimo/
7348_001/Default.htm, http://www.fda.gov/
ora/compliance_ref/bimo/7348_001/
foi48001.pdf.
Compliance Program 7348.809–Institutional
Review Boards, 1994. http://www.fda.gov/ora/
compliance_ref/bimo/7348_809/irb-cp7348-
809.pdf.
Compliance Program 7348.810–Bioresearch
Monitoring – Sponsors, Contract Research
Organizations and Monitors, 2001. http://
http://www.fda.gov/ora/complianceref/bimo/7348
810/default. htm, http://www.fda.gov/ora/
compliance_ref/bimo/7348_810/48-810.pdf.
Compliance Program 7348.811–Bioresearch
Monitoring–Clinical Investigators, FDA, 1997.
http://www.fda.gov/ora/compliance_ref/bimo/
7348_811/default.htm, http://www.fda.gov/ora/
ftparea/compliance/48_811.pdf.Information Sheets:Computerised Systems Used in Clinical
Trials. FDA, 1999. http://www.fda.gov/ora/
compliance_ref/bimo/ffinalcct.htm.Enforcement Policy: Electronic Records;
Electronic Signatures – Compliance Policy
Guide; Guidance for FDA Personnel,FDA,- http://www.fda.gov/ora/compliance_
ref/part11/FRs/updates/cpg-esig-enf-noa.htm.
Guidance. Financial Disclosure by Clinical
Investigators, FDA, 2001. http://www.fda.gov/
oc/guidance/financialdis.html.Guidance for Institutional Review Boards and
Clinical Investigators, FDA, 1998. http://
http://www.fda.gov/oc/ohrt/irbs/default.htm.Guidance for Institutional Review Boards,
Clinical Investigators, and Sponsors: Excep-
tions from Informed Consent Requirements for
Emergency Research, FDA, 2000. http://
http://www.fda.gov/ora/compliance_ref/bimo/err_
guide.htm.Guideline for the Monitoring of Clinical Inves-
tigations, FDA, 1988. http://www.fda.gov/cder/
guidance/old006fn.pdf.Guideline on the Preparation of Investiga-
tional New Drug Products (Human and
Animal), Department of Health & Human Ser-
vices, FDA, April 1991. http://www.fda.gov/
cder/guidance/old042fn.pdf.Inspection and Warning Letters:Clinical Investigator Inspection List. http://
http://www.fda.gov/cder/regulatory/investigators/
default.htm.156 CH12 GOOD CLINICAL PRACTICES