brief description about good clinical practice

1. GOOD CLINICAL
PRACTICE
Presenter : Dr Mohamed Ajeem
Moderator : Dr Pramod

2. CONTENTS
• DEFINITION
• EVOLUTION OF GCP
• PRINCIPLES OF GCP
• INSTITUTIONAL REVIEW BOARD/ ETHICS COMMITEE
• INFORMED CONSENT
• SPONSOR
• INVESTIGATOR
• SERIOUS ADVERSE EVENTS

3. DEFINITION
• Good clinical practice is an international ethical and scientific
quality standard for designing, conducting, recording and
reporting clinical trials that involve the participation of
human subjects

4. EVOLUTION OF GCP

5. THE NUREMBERG CODE- 1946
• Dec 9, 1946 – American military tribunal opened criminal
proceedings against 23 leading German physicians and
administrators for crimes against Humanity
• German physicians conducted medical experiments on
thousands of camp prisoners without their consent

6. • Most of the participants were dead or
permanently disabled
• 1948 – Nuremberg code was
established stating that the voluntary
consent of the human participants are
absolute essential

7. KEFAUVER-HARRIS AMENDMENTS
• 1962 – Drug manufacturers were
required to prove FDA the effectiveness
and safety of their product before
marketing
• This amendment was a response to
Thalidomide tragedy

8. TUSKEGEE SYPHILIS STUDY
• Study of progression of syphilis in 600 low income
African-American by U.S public health
• Many died from complication of syphilis
• 1974- “National research Act” passed for
protection of Human subjects of biomedical
research

9. BELMONT REPORT- 1979
1. Beneficence – maximise benefits and
minimize the risks
2. Respect for persons – protecting autonomy
of patients
3. Justice – equal distribution of burden and
benefits

10. PRINCIPLES OF GCP
1. Clinical trials should be conducted in accordance with the ethical
principles that have their origin in the Declaration of Helsinki, and
that are consistent with GCP and the applicable regulatory
requirement
2. Before trial is initiated, foreseeable risks and inconveniences should
be weighed against the anticipated benefit for the individual trial
subject and society. A trial should be initiated and continued only if
the anticipated benefits justify the risks.

11. 3. The rights, safety, and well being of the trial subjects are the most
important considerations and should prevail over interests of science
and society.
4. The available non-clinical and clinical information on an
investigational product should be adequate to support the proposed
clinical trial.
5. Clinical trials should be scientifically sound, and describes in a clear,
detailed protocol.

12. 6. A trial should be conducted in compliance with the protocol that has
received prior institutional review board (IRB)/independent ethics
committee (IEC) approval
7. 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.

13. 8. Each individual involved in conducting a trial should be qualified by
education, training, and experience to perform his or her respective
task
9. Informed consent should be obtained from every subject prior to
clinical trial participation.
10. All clinical trial information should be recorded, handled, and stored
in a way that allows its accurate reporting, interpretation, and
verification.

14. 11. The confidentiality of records that could identify subjects should be
protected, respecting the privacy and confidentiality rules in accordance
with the applicable regulatory requirement
12. 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.
13. Systems with procedures that assure the quality of every aspect of the trial
should be implemented.

15. THE INFORMED CONSENT
• It is a process by which a subject voluntarily confirms willingness
to participate in the trial
• The consent must be obtained before the study and
reported to the Ethics committee
• The subject is given opportunity to ask questions about the
clinical trial

16. • When a potential research subject who is deemed
incapable(minor) of giving informed consent is able to
give assent to decisions about participation in research,
the physician must seek that assent in addition to the
consent of the legally authorised representative

17. THE INFORMED CONSENT DOCUMENT
• Study Purpose
• Study Procedures
• Risks of Taking Part in the Study
• Benefits of Taking Part in the Study
• Alternatives to Taking Part in the Study

18. • Costs of Participation and Compensation in the Event
of Injury
• Payment for Taking Part in the Study
• Voluntary Nature of Study
• Confidentiality of Personal Information
• Study Contacts
• Duration of Participation and Number of People Taking
Part in the Study

19. STAKE HOLDERS

20. INSTITUTIONAL REVIEW BOARD(IRB)/ETHICS COMMITEE
• An Institutional Review Board (IRB) is an independent
body established to protect the rights and welfare of
human research participants.
• Any clinical investigation involving a product regulated
by the U.S. Food and Drug Administration (FDA) must
also be reviewed and approved by an IRB

21. MEMBERSHIP OF IRB
• An IRB must have a diverse membership that includes
both scientists and non-scientists. Scientist members
may include researchers, physicians, psychologists,
nurses, and other mental health professionals.
Nonscientist members of an IRB may have special
knowledge of a certain population (pregnant women,
children, or prisoners)

22. • A Chairperson
• 1-2 medical scientists
• 1-2 clinicians
• one legal expert
• one social scientist
• one philosopher/ ethicist
• One lay person from the community

23. CRITERIA FOR IRB APPROVAL
1. Risks to Participants are Minimized
2. Risks to Participants are Reasonable in Relation to
Anticipated Benefits
3. Selection of Participants is Equitable - No single gender or
racial, ethnic, or socioeconomic group should disproportionately
carry the burden or reap the benefits of the research.
4. Informed Consent is Properly Obtained and Documented

24. 5. Adequate Provision is Made to Protect Participant’s Privacy and
Maintain the Confidentiality of Data
6. Additional Safeguards are Included for Vulnerable Populations
• Children, Prisoners, Pregnant women
• Mentally disabled persons
• Patients with incurable diseases
• Medical, nursing, dental, and pharmacy students

25. SPONSOR
• Sponsor take the responsibility of initiation, management and financing of clinical
trial
A sponsor can be
• An individual
• A company
• An institution
• An organization

26. RESPONSIBILITIES OF SPONSOR
1. Quality Management
• The sponsor should implement a system to manage quality throughout
all stages of the trial process
• Ensure operational documents e.g. protocol and case report forms
(CRF) are clear, concise and consistent

27. 2. Medical Expertise
• The sponsor should designate appropriately qualified medical
personnel who will be readily available to advise on trial related medical
questions or problems
3. Trial Design
• The sponsor should utilize qualified individuals (e.g. statisticians,
Clinical pharmacologists, and physicians) as appropriate, throughout all
stages of the trial process

28. 4. Financing
• The financial aspects of the trial should be documented in an
Agreement between the sponsor and the Institution
5. Submission to Regulatory Authority
Responsibilities of the sponsor to obtain all of the documents required by
the regulatory authority for the clinical trial.
6. Safety information and ADR reporting

29. RESPONSIBILITIES OF INVESTIGATOR
• The investigator is a person responsible for the conduct of
the clinical trial
• Should be qualified by education, training and experience to
assume responsibility for the proper conduct of the trial
• Adequate resources – recruiting the required number of
subjects, qualified staffs and adequate facilities

30. • Medical care of trial subjects
• Communication with IRB/IEC – approval from IRB before
initiating the trial or information regarding suspension of the
trial
• Compliance with protocol
• Obtain informed consent of study subjects

31. • Record and reports – Report written summaries of status of
the trial to IRB
• Safety reporting – All Severe adverse events must be
reported to sponsor

32. SERIOUS ADVERSE EVENTS
• An untoward medical occurrence in a patient after administration
of pharmaceutical product which causes
• Death or life threatening
• Prolonged hospitalization
• Disability
• Congenital anomaly

34. THANK YOU
“THE HEALTH OF MY PATIENT WILL BE MY FIRST
CONSIDERATION,”