Debarment List. http://www.fda.gov/ora/
compliance_ref/debar/default.htm.
Disqualified/Restricted/Assurances List for
Clinical Investigators. http://www.fda.gov/ora/
compliance_ref/bimo/dis_res_assur.htm.
Notice of Initiation of Disqualification Proceed-
ings and Opportunity to Explain (NIDPOE)
Letters. http://www.fda.gov/foi/nidpoe/default.
html.
Public Health Service (PHS) Administrative
Actions Listings. http://silk.nih.gov/public/
[email protected].
Warning Letters. http://www.fda.gov/foi/
warning.htm.
Forms:
Form FDA 1571 – Investigational New Drug
Application (IND). http://forms.psc.gov/forms/
FDA/FDA-1571.pdf.
Form FDA 1572 – Statement of Investigator.
http://forms.psc.gov/forms/FDA/FDA-
1572.pdf.
Form FDA 3454 – Certification: Financial Inter-
ests and Arrangements of Clinical Investigators.
http://forms.psc.gov/forms/fda3454.pdf.
Form FDA 3455 – Disclosure: Financial Inter-
ests and Arrangements of Clinical Investigators.
http://forms.psc.gov/forms/FDA/FDA-
3455.pdf.
International ICH:
Clinical Safety Data Management: Definitions
and Standards for Expedited Reporting,
International Conference on Harmonization
[ICH] of Technical Requirements for the
Registration of Pharmaceuticals for Human
Use, 1994. http://www.ifpma.org/pdfifpma/
e2a.pdf.
Clinical Safety Data Management: Periodic
Safety Update Reports for Marketed Drugs,
International Conference on Harmonization
[ICH] of Technical Requirements for the
Registration of Pharmaceuticals for Human
Use, 1996. http://www.ifpma.org/pdfifpma/
e2c.pdf.
Note for Guidance on Structure and Content of
Clinical Study Reports, International Confer-
ence on Harmonization [ICH] of Technical
Requirements for the Registration of Pharma-
ceuticals for Human Use, 1995. http://www.
ifpma.org/pdfifpma/e3.pdf.
Guideline for Good Clinical Practice. Interna-
tional Conference on Harmonization [ICH] of
Technical Requirements for the Registration of
Pharmaceuticals for Human Use, 1996. http://
http://www.ifpma.org/pdfifpma/e6.pdf.
General Considerations for Clinical Trials.
International Conference on Harmonization
[ICH] of Technical Requirements for the Regis-
tration of Pharmaceuticals for Human Use,
Statistical Principles for Clinical Trials.Inter-
national Conference on Harmonization [ICH] of
Technical Requirements for the Registration of
Pharmaceuticals for Human Use, 1998. http://
http://www.ifpma.org/pdfifpma/e9.pdf.
WHO:
Good manufacturing practices for pharmaceuti-
cal products supplementary guidelines for the
manufacture of investigational pharmaceutical
products for studies in humans,1994.http://
saturn.who.ch/uhtbin/cgisirsi/
ThuþSepþþ 7 þ13:17:28þMETþDSTþ2000/
0/49.
International Ethical Guidelines for Biomedical
Research Involving Human Subjects, Council for
International Organizations of Medical Sciences
[CIOMS] in collaboration with the World Health
Organization [WHO], 1993. http://saturn.who.ch/
12.8 SOURCES OF INTERNATIONAL GUIDELINES/REGULATIONS FOR GCP 157