on good clinical practices

1. Good Clinical Practice (GCP) is an international ethical and
scientific standard for conducting biomedical and behavioral
research involving human participants.
The objective of this guideline is to provide a unified standard
across the European Union (EU), Japan, the United States,
Canada, and Switzerland to facilitate the mutual acceptance of
data from clinical trials by Regulatory Authorities.
The current system of Good Clinical Practice has evolved, in part,
in response to revelations of past episodes in which research
participants were grossly abused.
Exposure of these incidents provided much of the momentum for
the development of regulations and ethical guidelines on the
protection of human research participants.

2. Three basic ethical principles of equal importance, namely
respect for persons,
beneficence, and
Justice
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

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

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

5. The International Conference on Harmonisation (ICH-GCP)
GCP is an international quality standard that is provided by
the International Conference on Harmonisation (ICH)
Goals:
Harmonize technical procedures and standards; improve
quality; speed time to market
In 1997, the FDA endorsed the GCP Guidelines developed by
ICH
ICH guidelines have been adopted into law in several
countries, but used as guidance for the FDA in the form of
GCP

6. 13 principles of ICH-GCP
• Ethics:
• 1. Ethical conduct of clinical trials
• 2. Benefits justify risks
• 3. Rights, safety, and well-being of subjects prevail
• Protocol and science:
• 4. Nonclinical and clinical information supports the
trial
• 5. Compliance with a scientifically sound, detailed
protocol

7. 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:
9. Freely given from every subject prior to participation.
Data quality and integrity:
10. Accurate reporting, interpretation, and verification
11. Protects confidentiality of records z Investigational Products
12. Conform to GMP’s and used per protocol z Quality Control/Quality Assurance
13. Systems with procedures to ensure quality of every aspect of the trial

8. DECLARATION OF HELSINKI ICH-GCP
Ethical principles e.g. ethical and
scientific
Broader principles e.g. ethical, scientific
& operational for designing, conducting,
reporting & RECORDING TRIALS
FOCUS-Physicians in research FOCUS-Drug sponsors, investigators, IRBs
World Medical Assembly-International
medical societies
Representatives from industry and public
health
Guidance with broad recommendations Guidance document but has the effect
of Law when put into Regulation

9. International Standards Organization International Standards
Organization -ISO 14155:
Clinical Investigation of Medical Devices for Human Subjects –
Assists sponsors, monitors, and clinical investigators in the
design and conduct of device clinical investigations – Assists
regulatory bodies and ethics committees in their roles of
reviewing clinical investigational plans

10. What constitutes Good Clinical Practice in device research?
 IRB-approved protocol
 Valid Informed Consent
 Monitoring Plan
Adverse Device Effect Reporting [Adverse Event (AE) or Serious Adverse
Event (SAE)]
 Proper documentation
 Valid data collection/reporting procedures

11. Who is responsible for GCP compliance?
Sponsors
Clinical Investigators (CIs)
Independent Ethics Committees (IECs) – Institutional Review Boards
(IRBs)
Contract Research Organizations (CROs)
Research nurses
Clinical Research Coordinators (CRCs)
Clinical Research Associates (CRAs)
Medical monitors
Data entry personnel
Others

12. How does FDA implement GCP?
21 CFR 11 – Electronic Records & Signatures
21 CFR 50 – Protection of Human Subjects
21 CFR 54 – Financial Disclosure
21 CFR 56 – Institutional Review Boards
21 CFR 812 – Investigational Device Exemptions
21 CFR 814 – Premarket Approval of Medical Devices

13. SUMMARY
Good Clinical Practice (GCP) is an international ethical and scientific
standard for the design, conduct, performance, monitoring,
auditing, recording, analysis, and reporting of clinical trials.
This standard provides assurance that:
The rights, safety, well-being, and confidentiality of trial
participants are protected.
The data collected in clinical trials as well as the reported results of
clinical trials are credible and accurate.
The current system of Good Clinical Practice has evolved, in part, in
response to revelations of past episodes in which research
participants were grossly abused.

14. The Good Clinical Practice guidelines provide a framework for the fair,
scientifically sound conduct of research studies involving human participants.
Therefore, all trials should be conducted according to Good Clinical Practice
(GCP) and all research staff should be trained and remain current in GCP.
All key personnel who submit applications to the National Institutes of Health
for competing or noncompeting projects that involve human research
participants must receive training in the protection of human research
participants.
The Code of Federal Regulations (CFR) is the codification (systematic
arrangement) of rules published in the Federal Register by the executive
departments and agencies of the U.S. Government.
The principles of Good Clinical Practice are codified in several sections, or
titles, of the CFR. Noncompliance with these regulations may result in
suspension of a research study as well as fines and penalties

15. Central Roles:
Sponsor
Principal Investigator
Other Roles
Research Site Staff

16. Sponsor:
MONITORING
Data and Safety Monitoring
Quality Assurance and Quality Control (ICH GCP 5.1)
Medical Expertise (ICH GCP 5.3)
STUDY DESIGN & MANAGEMENT Study Design and Management (ICH GCP
5.4, 5.5))
TRANSFER OF OBLIGATIONS Transfer of Trial-Related Obligations

17. OBLIGATIONS OF PRINCIPAL INVESTIGATOR
QUALIFICATIONS AND AGREEMENTS –ICH GCP-4.1
RESOURCES
IRB/IEC/IC AND PROTOCOL COMPLIANCE- ICH GCP 4.4 and ICH GCP 4.5
MEDICAL CARE OF RESEARCH PARTICIPANTS -ICH GCP 4.3
CONTROL AND USE OF INVESTIGATIONAL PRODUCTS INCLUDING RANDOMIZATION
AND UNBLINDING.- ICH GCP 4.6 and ICH GCP 4.7.
INFORMED CONSENT ICH GCP 4.8
 DOCUMENTATION REQUIREMENTS INCLUDING REPORTS I--CH GCP 4.9
Premature Suspension or Termination of Study-- ICH GCP 4.12
ADDRESSING PROGRESS,SAFETY AND FINAL TRIAL STATUS.-- ICH GCP 4.13
OBLIGATIONS OF GCP-INVESTIGATOR, SPONSOR & MONITORS

18. OBLIGATIONS OF SPONSOR
Selecting the investigator(s)
Providing investigator(s) with the necessary information to conduct the clinical trial
Ensuring proper monitoring of the clinical study
Ensuring all the necessary ethic review(s) and approval(s) are obtained
Preparing and submitting clinical trial application(s) and amendment(s) to the
appropriate regulatory agencies
Ensuring that any reviewing ethics board and regulatory agencies are promptly informed
of any significant new information (for example, important findings that affect product
safety) in a clinical study
Ensuring compliance with labelling, reporting and record-keeping requirements
Refraining from engaging in promotional activities and other prohibited activities such as
commercializing an investigational medical device
Ensuring that the clinical study is conducted in accordance with Good Clinical
Practice (GCP)

19. Additional considerations-OTHER ROLES and Research Site Staff
Sponsor-investigators also generally need to manage the following1:
Securing funding for the clinical trial
Applying for the appropriate insurance
Generating the appropriate clinical trial documentation (for example, informed
consent, protocols) and submissions (for example, ethics and/or regulatory
submissions)
Ensuring adequate resources are available for the duration of the trial (for
example, experienced staff, investigational and control products, clinical and
medical supplies, an analytical laboratory)
Creating appropriate written procedures (for example, standard operating
procedures related to GCP)
Meeting all the applicable regulatory requirements such as obtaining and
maintaining necessary approvals from the relevant ethics review boards and

20. Research Staff:
Nurses, Pharmacists, Counselors, Supervisors and Other Staff Nurses, pharmacists,
and other staff are responsible for carrying out study procedures as described in
the protocol (e.g., receiving and dispensing medications, conducting physical
examinations, delivering behavioral interventions) and for assessing and reporting
adverse events to appropriate staff.