The document provides an overview of good clinical practices (GCP) and the historical standards that contributed to its development. It discusses key milestones like the Nuremberg Code, Declaration of Helsinki, and Belmont Report that established ethical and quality standards for clinical research involving human subjects. The document also outlines the four phases of clinical trials and principles of GCP like prior approval, informed consent, and quality assurance. It notes that GCP provides an international quality standard to ensure the rights, safety, and well-being of clinical trial participants.
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
changes and yet everything is completely different."
Clinical Research has evolved a long way since its inception, whether documented or not. It traverses a long and amazing journey. The recorded history of clinical trials dates back to the biblical descriptions of 500 BC. The journey encompasses from dietary therapy - legumes and lemons - to drugs.
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
changes and yet everything is completely different."
Clinical Research has evolved a long way since its inception, whether documented or not. It traverses a long and amazing journey. The recorded history of clinical trials dates back to the biblical descriptions of 500 BC. The journey encompasses from dietary therapy - legumes and lemons - to drugs.
Origin and principles of international conference on harmonization- Good clin...AbhishekJoshi312
The ppt gives a basic information about ICH-GCP, how it originated , what led to the formation of ICH-GCP guidelines and what are the principles of the guidelines.
Presentation on theme: "GCP (GOOD CLINICAL PRACTISE)"Nevin Francis
Creating a comprehensive 3000-word essay on Good Clinical Practice (GCP) would be quite extensive and may not fit within the scope of our conversation here. However, I can provide you with a detailed outline and key points that you could expand upon to reach the desired word count.
**Introduction to Good Clinical Practice (GCP)**
- Definition and importance of GCP in clinical research.
- Historical development and international harmonization efforts.
**Ethical Considerations in GCP**
- The role of ethics in clinical trials.
- Informed consent process and protection of participants' rights.
**Designing Clinical Trials under GCP Guidelines**
- Key elements in the design of a clinical trial.
- Considerations for protocol development.
**Conducting Clinical Trials According to GCP**
- Responsibilities of sponsors and investigators.
- Patient recruitment and data management strategies.
**Safety Monitoring and Adverse Event Reporting**
- Monitoring patient safety and reporting adverse events.
- The role of Data Safety Monitoring Boards (DSMBs).
**Quality Assurance in Clinical Trials**
- Audits, inspections, and ensuring compliance with GCP.
- The significance of documentation and record-keeping.
**Statistical Considerations in Clinical Trials**
- Importance of statistical methods in trial design and analysis.
- Interpreting results and determining clinical significance.
**The Future of GCP and Clinical Research**
- Innovations in clinical trial methodology.
- The impact of technology on GCP and patient engagement.
**Conclusion**
- The ongoing importance of GCP for the integrity of clinical research.
- The global impact of GCP on healthcare and medicine.
Each of these sections can be elaborated to create a full essay that discusses the principles and practices of GCP in depth. For the most current and detailed information, you can refer to the ICH E6 (R2) Good Clinical Practice guidelines¹, which are recognized internationally and provide a comprehensive framework for conducting clinical trials that involve human subjects. Additionally, the draft version of the ICH E6 (R3) principles provides updated guidance on ethical trial conduct, participant safety, and reliable results².
Remember, while expanding on these points, it's essential to cite relevant guidelines, regulations, and literature to support your discussion and provide a well-rounded view of GCP.
Source: Conversation with Bing, 19/02/2024
(1) ICH E6 (R2) Good clinical practice - Scientific guideline. https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice-scientific-guideline.
(2) ICH-E6 Good Clinical Practice (GCP). https://database.ich.org/sites/default/files/ICH_E6-R3_GCP-Principles_Draft_2021_0419.pdf.
(3) ICH Guidance Documents | FDA. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/ich-guidance-documents.
(4) Good Clinical Practice Guidelines (India) - Rajiv Gandhi Centre for .... https://www.rgcb.res.in/documents/Good-Clinical-Practice-Gu
It contains following subheadings:
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TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
1. Good Clinical Practices
Dr. Fardan Qadeer
JR I, Department of Pharmacology
Moderator: Dr. Ali Ahmad
Head Dept. of Pharmacology
2. Basic Research
Disease
Recovery
Drug Recovery
Preclinical
Development
Clinical Trials Manufacturing
Not regulated
GLP
GCP
GMP
3. Drug discovery and development
PRE CLINICAL TRIAL CLINICAL TRIAL
HUMANS
Adverse
Effect
Ethical
issues
Drug Toxicity
4. Phase I
• Checking for
safety
• 10-20
healthy
volunteers
• Unexpected
side effects
may occurs
Phase II
• Checking for
efficacy
• ~ 200
samples
• How good is
the
intervention
• If not good,
normally
detect here
Phase III
• Checking
effectiveness
• ~ 1000s
samples
• Looking for
rare side
effect
Phase IV
• Test long
term safety
• Real patients
• Involve
untested
group of
people
5. Good Clinical Practices (GCP) is an
international ethical & scientific
quality standard for designing,
conducting, recording & reporting
trials that involve the participation of
human subjects.
It ensures the
RIGHTS
SAFETY
WELL BEING
Designing
Clinical Trials
or Studies
Conducting
Monitoring
Recording
Reporting
Analysis
6. HISTORICAL BACKGROUND
Nuremberg Code, 1946
Kefauver Amendments, 1962 – Thalidomide
Declaration of Helsinki, 1964
National Research Act, 1974 - Tuskegee Syphilis Study
(1932-1972)
Belmont Report, 1979
7. Nuremberg Code:1946
German Physicians conducted medical experiments on prisoners of war
without their consent in during the time of Nazi rule.
Most of the participants of these experiments died or were permanently
crippled.
8. • In December 9, 1946 - American military
tribunal opened criminal proceedings
against 23 leading German physicians and
administrators for crimes against humanity
– 16 of them were found guilty
• The Nuremberg Code was established in
1948, stating that "The voluntary consent
of the human participant is absolutely
essential,"
• It did not carry the force of law, but the
Nuremberg Code was the first
international document which
advocated voluntary participation
and informed consent.
9. Kefauver Amendments-1960
• Thalidomide was as a sedative
during pregnancy in Europe but
was not approved by US FDA
• This lead to deformities in foetus
• 1962 US Senate hearings Kefauver
Amendments passed into law -
For the first time, drug
manufacturers were required to
prove to the FDA the
effectiveness of their products
before marketing them
10. Declaration of Helsinki-1964
• World Medical Association - recommendations guiding medical doctors in
biomedical research involving human participants
1. Research with humans should be based on the results from laboratory and
animal experimentation
2. Research protocols should be reviewed by an independent committee prior
to initiation
3. Informed consent from research participants is necessary
4. Research should be conducted by medically/scientifically qualified
individuals
5. Risks should not exceed benefits
• Revised - 1975, 1983, 1989, 1996, 2000, 2002, 2004, 2008
11. Tuskegee Syphilis Study- 1932 to 1972
• The US Public Health Services conducted a Syphilis Study
on 600 low income African-American individuals
• During this study many people died of syphilis
• Stopped in 1973 by the U.S. Department of Health,
Education, and Welfare
• 1974 National Research Act passed - National Commission
for the Protection of Human Subjects of Biomedical and
Behavioural Research established
• The commission produce Belmont Report (1979)
12. Belmont Report-1979
National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research
13. Key points:
• To make sure the study is approved by an IRB
• Get informed consent from the patient
• Be sure that the patient understands the full extent to the experiment, and if not contact the
study coordinator
• Make sure the patient wasn't coerced into doing the experiment by means of threatening or
bullying
• Be careful of other effects of the clinical trial that was not mentioned, and report it to the
proper study coordinator
• Support the privacy of the patients identity, their motivation to join or refuse the experiment.
• Ensure all patients get at the least, minimal care needed
14. ICH
• The International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human
Use (ICH) is a joint initiative the experts in pharmaceutical industry
of Europe, Japan and the United States to discuss scientific and
technical aspects of pharmaceutical product registration.
• 1980s-The European Union began
harmonising regulatory
requirements.
• 1989- Europe, Japan, and the United
States began creating plans for
harmonisation;
• 1990-ICH was created in April 1990
at a meeting in Brussels
15. Harmonisation would lead to a more economical use of human, animal
and material resources, and the elimination of unnecessary delay in the
global development and availability of new medicines while
maintaining safeguards on quality, safety, and efficacy, and regulatory
obligations to protect public health.
Co sponsors
Observers
Non voting member
coordinates its technical input to ICH through its
Scientific and Regulatory Section
Steering Committee
16. Drug Regulatory authority of India is also
invited in ICH bi-annual meetings.
• DRH representatives participate in the
Global Cooperation session of the ICH
Steering Committee (SC) to discuss
capacity-building and share
experience/challenges on the
implementation of ICH Guidelines.
• Representatives also listen to ICH technical
topics discussed by the SC during meetings
and are invited to nominate technical
experts in Expert Working
Groups/Implementation Working Groups to
contribute to the development of ICH
Guidelines.
17.
18. Principles of ICH GCP
• 2.1 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(s).
• 2.2 Before a 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.
19. • 2.3 The rights, safety, and well-being of the trial
subjects are the most important considerations and
should prevail over interests of science and society.
• 2.4 The available nonclinical and clinical information
on an investigational product should be adequate to
support the proposed clinical trial.
20. • 2.5 Clinical trials should be scientifically sound, and
described in a clear, detailed protocol.
• 2.6 A trial should be conducted in compliance with the
protocol that has received prior institutional review
board (IRB)/independent ethics committee (IEC)
approval/favourable opinion.
21. • 2.7 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.
• 2.8 Each individual involved in conducting a trial should be
qualified by education, training, and experience to perform
his or her respective task(s).
22. • 2.9 Freely given informed consent should be obtained
from every subject prior to clinical trial participation.
• 2.10 All clinical trial information should be recorded,
handled, and stored in a way that allows its accurate
reporting, interpretation and verification.
23. • 2.11 The confidentiality of records that could identify subjects
should be protected, respecting the privacy and confidentiality
rules in accordance with the applicable regulatory
requirement(s).
• 2.12 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.
• 2.13 Systems with procedures that assure the quality of every
aspect of the trial should be implemented.
24. GCP in India
The Main regulatory laws operating in India are the Drug and
Cosmetics Act (1940) and the Drugs and Cosmetics Rules
(1945).
SCHEDULE Y
Import and/ or
manufacture of
new drugs
Clinical
trials
25. The latest amendment in Schedule Y says:
• The clinical trial Sponsor is responsible for implementing and
maintaining quality assurance systems to ensure that the clinical trial
is conduced and data generated, documented and reported in
compliance with the protocol and GCP Guidelines
26. Pre-requisites for the study
Investigational Pharmaceutical Product
Pre-Clinical supporting data
Protocol
Ethical & Safety Considerations
Record Keeping
and Data
Handling
Statistics
Responsibilities
Sponsor
The Monitor
Investigator
Quality
Assurance
All research involving
human subjects should
be conducted in
accordance with the
ethical principles
contained in the current
revision of Declaration
of Helsinki
27. Principles of essentiality
• Whereby, the research entailing the use of human subjects is considered to be absolutely essential after a
due consideration of all alternatives
Principles of voluntariness, informed consent and community agreement
• Full information about the study
• Written and informed consent
• Risk and harm arising from the study
• Right to withdraw from the study voluntarily
Principles of non-exploitation
• Involvement in the research or experiment; and, irrespective of the social and economic condition or
status, or literacy or educational levels attained by the research subjects
Principles of privacy and confidentiality
• The identity and records of the human subjects of the research or experiment are as far as possible kept
confidential
28. Principles of precaution and risk minimisation
• It ensures that the research subject and those affected by it are put to the minimum risk, suffer from no
irreversible adverse effects and, generally, benefit from and by the research or experiment.
Principles of professional competence
• The research is conducted at all times by competent and qualified persons
Principles of accountability and transparency
• The research or experiment will be conducted in a fair, honest, impartial and transparent manner
Principles of the maximisation of the public interest and of distributive justice
• The research or experiment and its subsequent applicative use are conducted and used to benefit all
human kind
29. Principles of institutional arrangements
• All arrangements should be made in a bonafide and transparent manner;
• Ensure that research reports, materials and data connected with the research are duly preserved and archived.
Principles of public domain
• The research is brought into the public domain so that its results are generally made known through scientific and other
publications
Principles of totality of responsibility
• whereby the professional and moral responsibility, for the due observance of all the principles, guidelines
or prescriptions laid down generally or in respect of the research or experiment
Principles of compliance
• there is a general and positive duty on all persons, conducting, associated or connected with any research
entailing the use of a human subject to ensure that both the letter and the spirit of these guidelines
30. • “Let not hatred of any people keep you from dealing justly. Deal justly,
that is nearer to your duty. Observe your duty to God. Lo! God is
Informed of what ye do." (Quran 5.8)
Editor's Notes
Dr. karl brandit
German-contargan
Phocomelia
Used in leprosy and Multiple myeloma
Three basic ethical principals
Autonomy/respect for persons (Individuals should be treated as autonomous agents & Persons with diminished autonomy are entitled to protection)
Beneficence (Human participants should not be harmed & Research should maximize possible benefits and minimize possible risks) and
Justice (benefits and risks of research must be distributed fairly)
EU-Europian union
EFPIA-Europian fredaration of pharmaceutical industry and associations, situated in Brusells consists of 31 national pharmaceutical companies and associated who carry out drug research
MHLW-ministry of health and labour welfare japan
JPMA-japan Pharmacutical manufacturing asso.
FDA-it is the wrlds largest drug regulatory authority
EFTA-European free trade assoc.
IFPMA-Int. frederation of pharmaceutical menuacturing asso
PhRMA-Pharamacutical research and manufacturer of America
Sponser-responsible for selecting the investigator and the institution
The monitor is the principal communication link between the sponsor and the investigator and is appointed by the sponsor.
Investigator-qualified by the mci. Familiar with the safety and efficacy guidelines