Principles and Practice of Pharmaceutical Medicine

testing of medicinal products, Official Journal of
the European Communities, 1991.
Commission Directive 2005/28/EC of 8 April
2005 laying down principles and detailed
guidelines for good clinical practice as regards
investigational medicinal products for human
use, as well as the requirements for authorization
of the manufacturing or importation of such
products.
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 medic-
inal products for human use. http://europa.eu.int/
eur-lex/en/lif/dat/2001/en_ 301L0020.html.
Good Manufacturing Practice (GMP) Directive
2003/94/EC.EU Directive on GMP.
Guide to Good Manufacturing Practices,Annex
13 , Manufacture of Investigational Medicinal
Products, July 2003.The Rules Governing Medic-
inal Products in the European Community, Vol. 4,
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.

United Kingdom

Clinical Trial Compensation Guidelines, Associa-
tion 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://
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 Commit-

tees in Medical Research Involving Human Sub-

jects, 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.rcplon-

don.ac.uk/pubs/pub_print_bytitle.htm.

Governance Arrangements for NHS Research

Ethics Committees: (Section A–General Stan-

dards 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/gov-

home.htm.

The Medicines for Human Use (Clinical Trials)

Regulations 2004, Statutory Instrument 2004, No.

1031, HMSO.

United States

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_01/21cfr11_01.html.

12.8 SOURCES OF INTERNATIONAL GUIDELINES/REGULATIONS FOR GCP 155