This document defines key terms related to clinical research and drug development:
- It describes terms such as investigational product, protocol, informed consent, inclusion/exclusion criteria, adverse events, randomization, blinding, case report forms, data monitoring committees, good clinical practice guidelines, investigators, monitors, and institutional review boards.
- It provides concise definitions of these important concepts to clarify roles and procedures in clinical trials and medical research involving human subjects.
“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”.
“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”.
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
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.
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
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
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.
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
LBDA: Ask the Expert - Daniel Kaufer Live Webinar June 2016wef
Dr. Daniel Kaufer's live presentation made at the LBDA hosted webinar of June 15, 2016. Review additional material and event recording at www.worldeventsforum.net/lbda and lbda.org
Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis, or for relieving symptoms of a disease. here some basic terms associated with clinical research are mentioned in the presentation, which proves helpful to understand the basic knowledge about research.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
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.
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.
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.
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
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.
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.
2. Systematic study of drug/device in human
subjects
Investigation in human subjects intended to
discover clinical/pharmacodynamic effects of
IP
To identify adverse reactions to IP
To study absorption, distribution, metabolism
and excretion of IP with the objective to
ascertain its safety and efficacy
3. International ethical and scientific quality
standard for designing, conducting,
monitoring, recording, reporting, auditing
clinical studies
Ensures that data reported is credible and
accurate, and that subject’s rights and
confidentiality are protected
4. A detailed plan that sets forth the objectives, study
design, and methodology for a clinical trial
A study protocol must be approved by an IRB
before investigational drugs may be administered
to humans
Protocol Amendment : Changes or clarifications
made in writing to the original protocol
5. Compilation of clinical and nonclinical data
on the investigational product relevant to
study of IP in human subjects
6. Process by which subject voluntarily confirms
his or her willingness to participate
Precedes enrollment
Documented by means of written, signed and
dated consent form
7. Inclusion: Criteria that prospective subjects
must meet to be eligible for participation in
study
Exclusion: list of criteria which excludes
potential subject from participation in study
8. An independent body constituted of
medical/scientific and non-scientific
members
To ensure protection of rights, safety and
well-being of human subjects in a trial
Provide protection by reviewing and
approving/providing favourable opinion on
the protocol
Checks the suitability of investigators,
facilities, methods to be used in obtaining
and documenting informed consent
10. Individual who is a participant in research
May be either a healthy human or patient
Should have signed the informed consent
document prior to his participation in a study
11. Untoward medical occurrence in patient
administered pharmaceutical product
Does not necessarily have causal relationship
with the treatment
Can be any unintended sign
When an AE has been determined to be
related to the investigational product, it is
considered an Adverse Drug Reaction
12. Baseline assessment: assessment of subjects
as they enter a trial and before they receive
any treatment
Randomisation: process of assigning trial
subjects to treatment/control groups using
element of chance
13. A study in which all parties, (patient,
physician and study coordinator) are
informed of the drug and dose being
administered. In an open-label study, none of
the participants are given placebos
14. Study in which neither the subject nor
investigator nor research team know what
treatment subject is receiving
The expectations of the doctor/participant
about the experimental drug do not affect the
outcome
"Blinded" studies are conducted to prevent
the unintentional biases that can affect
subject data when treatment assignments are
known
15. The process through which one or more
parties to a clinical trial are unaware of the
treatment assignments
In a single-blinded study, usually the subjects
are unaware of the treatment assignments
In a double-blinded study, both the subjects
and the investigators are unaware of the
treatment assignments.
16. Printed, electronic document designed to
record protocol-required information to be
reported to sponsor
Record of clinical study observations that a
protocol designates must be completed
17. CRA:Person employed by sponsor/CRO who
monitors progress of investigator sites
CRC: person who handles most of
administrative responsibilities of trial
Acts as a liasion between the site and
sponsor
Reviews all data and records before monitor’s
visit
18. Written description of trial/study conducted
in human subjects in which clinical/statistical
description, analysis are integrated into
single report
19. In which the investigative drug is compared
against another product (active drug/placebo)
A comparator is an investigational/marketed
product or placebo used as a reference
20. Organisation contracted by sponsor to
perform one or more of sponsor’s trial-
related duties and functions
21. Researchers who periodically review data
from clinical studies
An independent committee composed of
clinical research experts
It reviews data while a clinical trial is in
progress to ensure that participants are not
exposed to undue risk
A DSMB may recommend that a trial be
stopped if there are safety concerns or if the
trial objectives have been achieved
22. Set of recommendations/basic principles that
guide medical doctors in conduct of research
involving human subjects
Published first in 1964 sought to address
ethical aspects of clinical research
Has made informed consent a central
requirement for ethical research
23. Research in vulnerable groups should be
conducted only if necessary to promote the
health of that population
Benefits, risks, effectiveness of new method
should be tested against best current
methods
24. Electronic record designed to record
information required by the protocol to be
reported to sponsor on each trial subject
25. Person who is independent of the trial who
attends the informed consent process if
subject or his LAR cannot read
Impartial witness reads the informed consent
form and any other written information
supplied to the subject
26. Individual or other body authorised to
consent on behalf of prospective subject
about the subject’s participation in clinical
trial
27. Active ingredient or placebo being
tested/used in clinical trial
Includes a product with marketing
authorisation when used for unapproved
condition, or when used to gain further
information about an approved use
28. A planned analysis intended to compare
treatment arms with regards to safety and
efficacy at any time prior to completion of
trial
Determined as part of the study protocol
29. Person responsible for conduct of clinical trial
at the site
Investigator is the responsible leader of the
team
30. Act of overseeing progress of a clinical trial
Ensuring it is conducted, recorded and
reported in accordance with protocol, SOP,
GCP
A written report submitted to the sponsor by
the monitor after each site visit is called
monitoring report
31. Term used for adverse event monitoring and
reporting
The science and activities relating to
detection, assessment, understanding and
prevention of adverse effects or any other
drug related problems
32. A new drug, antibiotic drug, or biological
drug that is used in a clinical investigation
IND application is a petition through which a
drug sponsor requests the regulatory
authority to allow human testing of its new
drug product
33. The compilation of all non-clinical, clinical,
pharmacological, pharmacokinetic and
stability information required about a drug by
the regulatory authority in order to approve
the drug for marketing
34. The standard against which experimental
observations are compared and evaluated
In many clinical trials, one group of patients
will be given an experimental drug or
treatment, while the control group is given
either a standard treatment for the illness or
a placebo
35. Before a drug may be tested on humans, pre-
clinical studies must be conducted on
animals to determine that the drug is safe
36. Study participants are usually assigned to
groups in such a way that each participant
has an equal chance of being assigned to
each treatment (or control) group
37. Official, detailed, written instructions for the
management of clinical trials. SOPs ensure
that all the functions and activities of a
clinical trial are carried out in a consistent
and efficient manner
38. Group/individual that cannot give informed
consent because of limited autonomy (e.g.,
children, mentally ill and prisoners)
Also refers to subjects who may be unduly
influenced to participate (e.g., students,
subordinates and patients)
39. Study supplies (i.e., study test article,
laboratory supplies, case report forms)
provided by the study sponsor to the
investigator
40. Study of processes of bodily absorption,
distribution, metabolism and excretion of
compounds and medicines
42. Treatment currently in wide use and approved
by FDA or other health authority, considered
to be effective in treatment of specific disease
or condition
43. Plan for precise procedure to be followed in
clinical trial
Includes planned and actual timing of events,
method of allocating treatments
44. Systematic and independent examination of
trial-related activities and documents
Determines if trial was conducted and data
recorded, analysed and accurately reported
acc. to protocol, GCP etc.
Audit report is written evaluation by the
sponsor’s auditor of the results of audit