Sources Of International Guidelinesregulations For

Australia

National Statement on Ethical Conduct in Research Involving Humans, National Health and Medical Research Council Act, 1992. http://www.health.gov.au/nhmrc/publications/synop-ses/e35syn.htm

Note for Guidance on Good Clinical Practice (CPMP/ICH/135/ 95). Annotated with TGA comments. Therapeutic Goods Administration [TGA] (Australia), Commonwealth Department of Health and Aged Care. The TGA has adopted CPMP/ICH/135/95 in principle but has recognised that some elements are, by necessity, overridden by the National Statement (and therefore not adopted) and that others require explanation in terms of 'local regulatory requirements', July 2000. http://www.health.gov.au/tga/docs/html/ ichl3595.htm

Note for Guidance on Clinical Safety Data Management (CPMP/ ICH/377/95). Annotated with TGA comments. Therapeutic Goods Administration (Australia), Commonwealth Department of Health and Aged Care. The TGA has adopted the Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting in principle, particularly its definitions and reporting time frames. However, there are some elements of CPMP/ICH/ 377/95 which have not been adopted by the TGA and other elements which require explanation in terms of 'local regulatory requirements', 2000. http://www.health.gov.au/tga/docs/ html/ich37795.htm

Canada

Code of Ethical Conduct for Research Involving Humans, Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, 1998. http:// www.nserc.ca/programs/ethics/english/policy.htm Clinical Trial Review and Approval, Drugs Directorate, Policy Issues, Health and Welfare Canada, 1995. TPP (Therapeutic Products Program, Canada) http://www.hc-sc.gc.ca/hpb-dgps/ therapeut/htmleng/whatsnew.html Clinical Trial Framework, Schedule 1024, Food and Drug Regulations. Therapeutic Products Directorate, Health Products and Food Branch, Health Canada, 2001. http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/schedule/gazette.ii/ sch-l024_e.pdf

European Union

Good Clinical Practice for Trials on Medicinal Products in the European Community, Committee for Proprietary Medicinal Products [CPMP] EEC 111/3976/88-EN, Brussels, 1990.

Commission Directive 91/507/EEC modifying the Annex to Council Directive 75/318/EEC on the approximation of the laws of Member States relating to the analytical, pharmacotoxicologi-cal and clinical standards and protocols in respect of the testing of medicinal products, Official Journal of the European Communities, 1991.

Commission Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. http://europa.eu.int/eur-lex/en/lif/dat/200l/ en_30lL0020.html

Manufacture of Investigational Medicinal Products, Annex to the EC Guide to Good Manufacturing Practice, EEC 111/3004/91-EN, Brussels, 1992.

Biostatistical Methodology in Clinical Trials in Applications for Marketing Authorizations for Medicinal Products, Committee for Proprietary Medicinal Products [CPMP] EEC 111/3630/ 92-EN, 1994.

Clinical Trial Compensation Guidelines, Association of the British Pharmaceutical Industry (ABPI), 1994.

Conduct of Investigator Site Audits, ABPI, 1993.

Good Clinical (Research) Practice, ABPI, 1996.

Good Clinical Trial Practice, ABPI, 1995.

Introduction to the Work of Ethics Committees, ABPI, 1997.

Patient Information and Consent for Clinical Trials, ABPI, 1997.

Phase IV Clinical Trials, ABPI, 1993.

Set of Clinical Guidelines, ABPI, 2000.

Structure of a Formal Agreement to Conduct Sponsored Clinical Research, ABPI, 1996. http://www.abpi.org.uk/

Fraud and Misconduct in Clinical Research, Royal College of Physicians of London, 1991.

Guidelines for Clinicians Entering Research, Royal College of Physicians of London, 1997.

Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects, Royal College of Physicians of London, 1997.

Research Involving Patients, Royal College of Physicians of London, 1990.

Research on Healthy Volunteers, Royal College of Physicians of London, 1986. http://www.rcplondon.ac.uk/pubs/pub_print_by-title.htm

Governance Arrangements for NHS Research Ethics Committees: (Section A - General Standards and Principles, Department of Health [DOH], Central Office for Research Ethics Committees [OREC], 2001 http://doh.gov.uk/research/rec

Guidelines for Good Pharmacy Practice in Support of Clinical Trials in Hospitals, Royal Pharmaceutical Society, 1994.

Guidance on Good Clinical Practice and Clinical Trials in the NHS, National Health Service, 1999. http://www.doh.gov.uk/ research/documents/gcpguide.pdf

Research Ethics Guidance for Nurses Involved in Research or Any Investigative Project Involving Human Subjects, Royal College of Nursing Research Society,1998 http://www.doh. gov.uk/ research/rd3/nhsrandd/researchgovernance/govhome.htm

Regulations:

Code of Federal Regulations [CFR], 21 CFR Ch 1, Food and Drug Administration [FDA], Department of Health and Human Services [DHHS]: Part 11 - Electronic Records; Electronic Signatures http://

www.access.gpo.gov/nara/cfr/waisidx_01/21cfrll_01.html 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 Boards http://www.access.gpo.gov/

nara/cfr/waisidx_01/21cfr56_01.html Part 312 - Investigational New Drug Application; http://www.ac-

cess.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 JH.htmT

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/complian-ce_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://www.fda.gov/ora/compliance_ref/bimo/7348_810/default .htm http://www.fda.gov/ora/compUance_ref/bimo/7348_810/ 48-810.pdf

Compliance Program 7348.811 - Bioresearch Monitoring - Clinical Investigators, FDA, 1997. http://www.fda.gov/ora/com-pliance_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, 1999 http://www.fda.gov/ora/compliance_ref/part11/FRs/up-dates/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://www.fda.gov/oc/ohrt/irbs/default .htm Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exceptions from Informed Consent Requirements for Emergency Research, FDA, 2000. http://www.fda.-gov/ora/complianceref/bimo/errguide.htm Guideline for the Monitoring of Clinical Investigations, FDA,

1988. http://www.fda.gov/cder/guidance/old006fn.pdf Guideline on the Preparation of Investigational New Drug Prod ucts (Human and Animal), Department of Health & Human Services, FDA, April 1991. http://www.fda.gov/cder/guidance/ old042fn.pdf

Inspection and Warning Letters:

Clinical Investigator Inspection List http://www.fda.gov/cder/

regulatory/investigators/default.htm 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_as-sur.htm

Notice of Initiation of Disqualification Proceedings 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-l57l.pdf Form FDA 1572 - Statement of Investigator http://forms.psc.

gov/forms/FDA/FDA-l572.pdf Form FDA 3454 - Certification: Financial Interests and Arrangements of Clinical Investigators http://forms.psc.gov/ forms/fda3454.pdf Form FDA 3455 - Disclosure: Financial Interests and Arrangements of Clinical Investigators http://forms.psc.gov/forms/ FDAZFDA-3455.pdf

International ICH:

Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, International Conference on Harmonisation [ICH] of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1994. http://www.ifp-ma.org/pdfifpma/e2a.pdf Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, International Conference on Harmonisation [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 Conference on Harmonisation [ICH] of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1995. http://www.ifpma.org/ pdfifpma/e3.pdf

Guideline for Good Clinical Practice. International Conference on Harmonisation [ICH] of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1996. http:// www.ifpma.org/pdfifpma/e6.pdf General Considerations for Clinical Trials. International Conference on Harmonisation [ICH] of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1997 http://www.ifpma.org/pdfifpma/e8.pdf Statistical Principles for Clinical Trials. International Conference on Harmonisation [ICH] of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1998. http://www.ifpma.org/pdfifpma/e9.pdf

WHO:

Good manufacturing practices for pharmaceutical products supplementary guidelines for the manufacture of investigational pharmaceutical products for studies in humans, 1994. http://saturn.who.ch/uhtbin/cgisirsi/Thu+Sep++7+13:17:28+ MET+DST+2000/0/49

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/uhtbin/cgisirsi/Thu+Sep++7+13: 17:28+MET+DST+2000/0/49

Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products, Division of Drug Management & Policies, World Health Organization, 1994. http://saturn. who.ch/uhtbin/cgisirsi/Thu+Sep++7+13:17:28+MET+DST+ 2000/0/49

Operational Guidelines for Ethics Committees that Review Biomedical Research, World Health Organization, 2000. http:// saturn.who.ch/uhtbin/cgisirsi/Thu+Sep++7+13:17:28+MET + DST+2000/0/49

World Medical Association:

Declaration of Helsinki. Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects, Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964, amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975, the 35th World Medical Assembly, Venice, Italy, October 1983, and the 41st World Medical Assembly, Hong Kong, September 1989, the 48th General Assembly, Somerset West, Republic of South Africa, October

1996, and the 52nd General Assembly, Edinburgh, Scotland, October, 2000. http://www.wma.net/e/policy/17-c_e.html

Other Related Publications by the Authors:

Bohaychuk W, Ball G (1994) Good Clinical Research Practices. An Indexed Reference to International Guidelines and Regulations, with Practical Interpretation (available from authors).

Bohaychuk W, Ball G (1996) GCP. A Report on Compliance. (available from authors)

Bohaychuk W, and Ball G (1998), GCP Audit Findings - Case Study 1, Quality Assurance Journal, Volume 3, Issue 2.

Bohaychuk W, and Ball (1998), 101 GCP SOPsfor Sponsors and CROs (available from authors, paper and diskette).

Bohaychuk W, and Ball (1998), GCP Audit Findings - Case Study 2, Quality Assurance Journal, Volume 3, Issue 3.

Bohaychuk W, Ball G, Lawrence G, Sotirov K (1998) A Quantitative View of International GCP Compliance. Appl Clin Trials February: 24-29 (first in a series of articles published approximately every 2 months).

Bohaychuk W, Ball G (1999) GCP compliance assessed by independent auditing: international similarities and differences. In Hamrell M (ed.), The Clinical Audit in Pharmaceutical Development Marcel Dekker: New York.

Bohaychuk W, Ball G (1999) GCP compliance: national similarities and differences. In Eur Pharmaceut Contract September.

Bohaychuk W, Ball G (1999) Conducting GCP-compliant Clinical Research (available from John Wiley & Sons Ltd, Baffins Lane, Chichester, West Sussex PO19 1UD, UK, www:inters-cience.wiley.com).

Bohaychuk W, and Ball G (2000), GCP Compliance Assessed by Independent Auditing. International Similarities and Differences, In The Clinical Audit in Pharmaceutical Development, edited by M Hamrell. (Marcel Dekker publishers)

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