This document provides an overview of good clinical practices (GCP) for clinical research and clinical trials. It discusses the definition of clinical research and clinical trials, the phases of clinical trials, important historical documents that shaped ethical standards like the Declaration of Helsinki and Nuremberg Code, and the key principles of GCP according to the WHO and ICH guidelines. These principles aim to ensure the safety and well-being of research subjects, scientific validity of the research, and compliance with regulations.
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.
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.
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.
“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”.
Good Clinical Practice Guidelines (ICH GCP E6).pptMohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Clinical Research Regulations (MRA 103T)
Unit 4 - Clinical Research Related Guidelines: Good Clinical Practice Guidelines (ICH GCP E6)
THE PRINCIPLES OF ICH GCP
INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITEE
Principal Investigator
Sponsor
Investigator's Brochure
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
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.
What is ICH- GCP?
Why is GCP important?
Outline the goals of GCP
Provide a historical perspective on GCP
WHO Principles of GCP
Principles: Defines, Application & Implementation.
Georgina Gal, Regulatory Affairs Manager, AbbVie, Hungary
Presentation at EIPG – BIPA Symposium “Clinical Trials Research” at the Faculty of Pharmacy, Medical University of Sofia, Sofia 2014.
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.
Introduction to Clinical Research RegulationsClinosolIndia
Clinical research plays a vital role in advancing medical knowledge, developing new treatments, and improving patient care. However, conducting clinical trials involves numerous ethical and regulatory considerations to ensure participant safety, data integrity, and compliance with applicable laws and guidelines.
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.
“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”.
Good Clinical Practice Guidelines (ICH GCP E6).pptMohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Clinical Research Regulations (MRA 103T)
Unit 4 - Clinical Research Related Guidelines: Good Clinical Practice Guidelines (ICH GCP E6)
THE PRINCIPLES OF ICH GCP
INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITEE
Principal Investigator
Sponsor
Investigator's Brochure
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
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.
What is ICH- GCP?
Why is GCP important?
Outline the goals of GCP
Provide a historical perspective on GCP
WHO Principles of GCP
Principles: Defines, Application & Implementation.
Georgina Gal, Regulatory Affairs Manager, AbbVie, Hungary
Presentation at EIPG – BIPA Symposium “Clinical Trials Research” at the Faculty of Pharmacy, Medical University of Sofia, Sofia 2014.
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.
Introduction to Clinical Research RegulationsClinosolIndia
Clinical research plays a vital role in advancing medical knowledge, developing new treatments, and improving patient care. However, conducting clinical trials involves numerous ethical and regulatory considerations to ensure participant safety, data integrity, and compliance with applicable laws and guidelines.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Receptor types, mechanism, receptor pharmacology, drug receptor interactions, theories of receptor pharmacology, spare receptors and new concepts like biased agonism
Good Manufacturing Practice (GMP) 2day course Jo Havemann
The following topics were presented to the participants through lectures, group discussions and exercises during 16 hours:
- Core values and guidelines of Good Laboratory Practice (GLP)
- Factors that might lead to questionable research & manufacturing practices and their impact
- GMP compliance, national & international regulations, guidelines and authorities
- Quality Management and Assessment
- Digital GMP Solutions
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
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...Dr Ghaiath Hussein
This is a series of presentations I gave in the Eastern Mediterranean Public Health Network (EMPHNET)'s Public Health Ethics (PHE) that was held in Amman in June 2014.
This presentation outlines the ethical issues in research, especially the international research in low-middle income countries
This is one of the lectures for the POGS Research Forum in Bacolod, mostly based on the chapter on Clinical Practice Guidelines for Ethics Review from the POGS Research Handbook: The Essentials. I hope this can be a guide for residents who are preparing their research proposal for ethical review.
Saudi Commission for Health Specialties, Part 1 of the series of lectures I gave for the PEER (Professionalism and Ethics Education for Residents) Project sponsored and organized by the Saudi Commission for Health Specialties (SCHS).
Hello friends. In this PPT I am talking about drugs used in the treatment of type 2 diabetes mellitus. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
AMA General considerations 12.6.23.pptxKarun Kumar
Hello friends. In this PPT I am talking about Antimicrobial drugs-General Considerations. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about general anaesthetics and skeletal muscle relaxants. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about drugs affecting blood. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Drugs & Aids with specific applications in dentalKarun Kumar
Hello friends. In this PPT I am talking about drugs & aids with specific applications in dental disorders. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about diuretics. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about Cardiovascular system drugs. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about CNS drugs. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about CNS drugs. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about Autacoids. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about Anti-viral drugs drugs. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about Anti-TB & anti leprosy drugs. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about antiseptics, disinfectants. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about antiprotozoal drugs. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about anti-fungal drugs. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about anti-cancer drugs. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about autonomic nervous system. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about autonomic nervous system. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
Hello friends. In this PPT I am talking about autonomic nervous system. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way.
AETCOM (Attitude, Ethics and Communication module)Karun Kumar
Hello friends. In this PPT I am talking about AETCOM (Attitude, Ethics and Communication module) of Pharmacology. If you like it, please do let me know in the comments section. A single word of appreciation from you will encourage me to make more of such videos. Thanks. Enjoy and welcome to the beautiful world of pharmacology where pharmacology comes to life. This video is intended for MBBS, BDS, paramedical and any person who wishes to have a basic understanding of the subject in the simplest way
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
2. What is Clinical Research ?
•Research conducted on
•Human subjects or
•Material of human origin
•Tissues,
•Specimens, and
•Cognitive phenomena
http://keck.usc.edu/Research/Clinical_Research/Definition.aspx
3. What is Clinical Trial ?
•Scientific studies
•Test the effectiveness of
•Treatment,
•Device, or
•Drug
•Find new & better ways
http://keck.usc.edu/en/Research/Clinical_Research/Clinical_Trials.aspx
4. Phases of Clinical Trial
Phase Primary goal Dose Patient monitor
Number of
participants
Preclinic
al
Testing of drug in non-
human subjects
Unrestricted
A graduate level
researcher-Ph.D.
In vitro & in vivo
animal models
Phase 0
Oral bioavailability & half-
life of drug
Subtherapeutic
Clinical
researcher
10 people
Phase I
Testing of drug on healthy
volunteers (safety)
Subtherapeutic
with asc. Doses
Clinical
researcher
20-100
Phase II
Testing of drug on patients
(efficacy & tolerability)
Therapeutic dose
Clinical
researcher
100-300
Phase III
Testing of drug on pts.
(confirm efficacy)
Therapeutic dose
Clinical research.
& Physician
1000-2000
Phase IV
Post-marketing
surveillance (A/E, D-D I)
Therapeutic dose Physician
Anyone seeking
treatment
Phase V Translational research No dosing None All reported use
DeMets D., Friedman, L., and Furberg, C.,(2010).Fundamentals of Clinical Trials.Springer 4th Edition
Goodman and Gilman's The Pharmacological Basis of Therapeutics, (2011) 12th Edition
5.
6. What are Good Clinical Practices ?
•More than any one document
•Collective compilation of many
•thoughts,
•ideas and
•learning moments
spanning the globe over
7. •International ethical and
scientific quality standard for
•Design,
•Conduct,
•Performance,
•Monitoring,
•Auditing,
•Recording,
•Analysis, and
•Reporting
of clinical trials
8. Historical Background
Year Event
460 B.C. Oath of Hippocrates
1930's U.S. Food, Drugs and Cosmetic Act
1947 Nuremberg Code
Dec. 10th 1948 Declaration of Human Rights
1962 Kefauver-Harris Amendment
1964 Declaration of Helsinki
1979 The Belmont Report
1982 International Guidelines for Biomedical Research Involving
Human Subjects (WHO & CIOMS)
1996 ICH-GCP guidelines issued
1997 ICH-GCP guidelines implemented
Vijayananthan A, Nawawi O.The importance of Good Clinical Practice guidelines
and its role in clinical trials.Biomed Imaging Interv J. 2008 Jan-Mar; 4(1).
9.
10.
11.
12. The death sentences imposed in
October 1946 were carried out by
Master Sergeant John C. Woods
(1903-50), who told a reporter from
Time magazine that he was proud of
his work. "The way I look at this
hanging job, somebody has to do it .
. . ten men in 103 minutes. That's
fast work."
http://www.history.com/topics/world-war-ii/nuremberg-trials
13. Brigadier General Telford Taylor, Chief of Counsel,
during the Doctors Trial, which was held in
Nuremberg, Germany, from December 9, 1946, to
August 20, 1947.
14. During testimony at the Doctors Trial, American
medical expert Dr. Leo Alexander points to scars on
Jadwiga Dzido’s leg. Dzido, a member of the Polish
underground, was a victim of medical experiments at
the Ravensbrüeck concentration camp. Nuremberg,
Germany, December 22, 1946.
15. Nazi physician Carl Clauberg who performed medical
experiments on prisoners in Block 10 of the
Auschwitz camp. Poland, between 1941 and 1944.
16. A prisoner in a compression chamber loses
consciousness (and later dies) during an experiment
to determine altitudes at which aircraft crews could
survive without oxygen. Dachau, Germany, 1942.
17. Victim of a medical experiment immersed in freezing
water at the Dachau concentration camp. Dachau,
Germany, between August 1942 and May 1943.
18. A Romani (Gypsy) victim of Nazi medical experiments
to make seawater potable. Dachau concentration
camp, Germany, 1944.
19. Photo of wounds left by a medical experiment. The
victim had been burned with phosphorous so that
medicaments could be tested
20. Nuremberg Code (1947)
•Voluntary consent of the
human subject is absolutely
essential
•Favorable risk/benefit ratio
•Research must help society
•Research should be based on
previous knowledge
21. •Participant must be free to
stop at any time
•Research should not cause
mental & physical suffering
•Research should avoid risk of
injury & death
22.
23. Declaration of Helsinki (1964)
•Well being of subject >
interest of science & society
•Consent should be in writing
•Limited use of placebo
•Greater access to benefit
29. Common Rule (1981)
•Describes the types of
research subject(s)
•Defines key terms such as
•Research,
•Human subject, and
•Minimal risk
30. •Sets forth requirements for
•IRB membership
•Review procedures
•Criteria for approval
•Lists requirements for
informed consent
31. Overview of Clinical research
process
Development of the trial protocol
Development of standard operating
procedures (SOPs)
Development of support systems and
tools
32. Selection of trial sites and the selection of properly
qualified, trained, and experienced investigators
and study personnel
Ethics committee review & approval of the protocol
Enrollment of subjects into the study:-
Recruitment,
Eligibility, &
Informed consent
Review by regulatory authorities
33. Safety management and reporting
Trial data acquisition: conducting the trial
The investigational product(s): quality, handling and
accounting
Monitoring the trial
34. Quality assurance of the trial
performance and data
Managing trial data
Reporting the trial
35. WHO principles for GCP
Principle 1 – Ethical Conduct
•Research involving humans
Scientifically sound
In accordance with
Declaration of Helsinki
37. Principle 3: Risk Identification
•Foreseeable risks and
discomforts and any
anticipated benefit(s)
To be identified
38. Principle 4: Benefit-Risk
Assessment
•Research initiated only if
anticipated benefit(s)
outweigh the risks
•Most important considerations
•Rights,
•Safety, and
•Well-being of trial subjects
39. Principle 5: Review by IEC/IRB
•Research should receive
independent (IEC/IRB)
approval prior to initiation
40. Principle 6: Protocol Compliance
•Research Conducted in
compliance with the
approved protocol
41. Principle 7: Informed Consent
•To be obtained
•From every subject
•Prior to research participation
•In accordance with national
culture(s) and requirements
42. Principle 8: Continuing review /
ongoing benefit-risk assessment
•Research Continued only if
the benefit-risk profile
remains favorable
46. •In a way that allows its
accurate
•Reporting,
•Interpretation, and
•Verification
47. Principle 12: Confidentiality /
Privacy
•Confidentiality of records
should be protected
•In accordance with the
applicable regulatory
requirement(s)
48. Principle 13: Good Manufacturing
Practice(s)
•Investigational products
should be
•Manufactured,
•Handled, and
•Stored
in accordance with applicable
GMP
49. Principle 14: Quality Systems
•Systems with procedures that
assure the quality of every
aspect of the trial should be
implemented
•Quality control (QC)
•Quality assurance (QA)
•Quality improvement (QI)
50. Code of Federal Regulations, Title
21
21 CFR 11: Electronic records
and signatures
21 CFR 50: Protection of
human subjects
21 CFR 54: Financial disclosure
by clinical investigators
51. 21 CFR 56: IRB that oversee
clinical trials
21 CFR 312: Investigational
New Drug Application
21 CFR 812: Investigational
Device Exemptions
56. Never ending debate
•Whether the "greater good"
trumps the rights of the
individual?
•Are individual’s rights what
make up the greater good?
•Is it the greater good that
allows for individual’s rights?
57. Take Home Message
•"If it wasn't documented, it
wasn't done.”
•GCP is more than a piece of
paper or a set of rules
•A mind-set of dedication that
ensures a high level of ethics
& quality in research