GOOD CLINICAL PRACTICE PRINCIPLES

2. Vulnerable Subjects
Examples are members of a group with a hierarchical
structure, such as medical, pharmacy, dental, and
nursing students, subordinate hospital and laboratory
personnel, employees of the pharmaceutical industry,
members of the armed forces, and persons kept in
detention. Other vulnerable subjects include patients
with incurable diseases, persons in nursing homes,
unemployed or impoverished persons, patients in
emergency situations, ethnic minority groups,
homeless persons, nomads, refugees, minors, and those
incapable of giving consent.

3. Good Clinical Practice (GCP)

GCP is defined as a standard for the design, conduct,
performance, monitoring, auditing, recording, analysis
and reporting of clinical trials or studies

GCP compliance provides public assurance that the
rights, safety and well-being of human subjects involved
in research are protected
GCPGCP

4. Goals of GCP
To protect the rights, safety and welfarerights, safety and welfare of humans
participating in research
To assure the quality, reliability and integrityquality, reliability and integrity of data
collected
To provide standards and guidelinesstandards and guidelines for the conduct
of clinical research
Good Clinical Practice = Ethics + Quality Data
GCP

5. Foundations for the ethical conduct of clinical
research

The Nuremberg CodeNuremberg Code (1947)

The Declaration of HelsinkiDeclaration of Helsinki (1964)

The Belmont ReportBelmont Report (1979)

International Conference on Harmonisation (ICH-GCP)

International Standards Organization 14155

Code of Federal Regulations

6. A Historical Perspective
Nuremberg Code (1947)
Voluntary participationVoluntary participation
Informed ConsentInformed Consent
Minimization of riskMinimization of risk
Belmont Report (1979)
Respect for PersonsRespect for Persons
BeneficenceBeneficence
JusticeJustice
Declaration of Helsinki (1964)
Well-being of subject takes precedenceWell-being of subject takes precedence
Respect for personsRespect for persons
Protection of subjects health and rightsProtection of subjects health and rights
Special protection for vulnerable populationsSpecial protection for vulnerable populations

7. THE PRINCIPLES OF ICH GCP
EthicsEthics:
1. Ethical conduct of clinical trials
2. Benefits justify risks
3. Rights, safety, and well-being of subjects prevail
Protocol and science:Protocol and science:
4. Nonclinical and clinical information supports the
trial
5. Compliance with a scientifically sound, detailed
protocol
GOODGOOD
CLINICALCLINICAL
PRACTICEPRACTICE

8. THE PRINCIPLES OF ICH GCP
Responsibilities:Responsibilities:
6. IRB/IEC approval prior to initiation
7. Medical care/decisions by qualified physician
8. Each individual is qualified (education, training,
experience) to perform his/her tasks
Informed Consent:Informed Consent:
9. Freely given from every subject prior to
participation

9. THE PRINCIPLES OF ICH GCP
Data quality and integrity:Data quality and integrity:
10. Accurate reporting, interpretation, and verification
11. Protects confidentiality of records
Investigational ProductsInvestigational Products
12. Conform to GMP’s and used per protocol
Quality Control/Quality Assurance
13. Systems with procedures to ensure quality of every
aspect of the trial
EDC
IPIP

10. THE PRINCIPLES OF ICH GCP

The rights, safety, and well-beingrights, safety, and well-being of the trial
subjects are the most important considerations and
should prevail over interests of science and society.

The available nonclinical and clinical informationnonclinical and clinical information
on an investigational product should be adequate to
support the proposed clinical trial.

11. THE PRINCIPLES OF ICH GCP

Clinical trials should be scientifically sound, and
described in a clear, detailed Protocol.

A trial should be conducted in compliance with the
protocol that has received prior institutional review
board (IRB)/independent ethics committee (IEC)
approval/favorable opinion.

12. THE PRINCIPLES OF ICH GCP

The medical care given to, and medical decisions
made on behalf of, subjects should always be the
responsibility of a qualified physician or, when
appropriate, of a qualified dentist.

Each individual involved in conducting a trial
should be qualified by education,training, and
experience to perform his or her respective task(s).

13. THE PRINCIPLES OF ICH GCP

Freely given informed consent should be obtained
from every subject prior to clinical trial
participation.

All clinical trial information should be recorded,
handled, and stored in a way that allows its
accurate reporting, interpretation, and verification.

14. THE PRINCIPLES OF ICH GCP

The confidentiality of records that could identify
subjects should be protected, respecting the privacy
and confidentiality rules in accordance with the
applicable regulatory requirement(s).

Investigational products should be manufactured,
handled, and stored in accordance with applicable
good manufacturing practice (GMP). They should
be used in accordance with the approved protocol.
Clinical
Trial
Drug