This document outlines the roles and responsibilities of members of a clinical trial study team. It discusses the investigator who leads the trial, the coordinator who manages the day-to-day operations, the sponsor who provides funding and oversight, the monitor who ensures compliance, and the contract research organization which provides additional support services. For each role, the document describes the main responsibilities which include following regulatory standards, protecting participant safety, ensuring protocol adherence, and reporting requirements.
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
What is The Clinical Trial Approval Process In India.pdfPranshuCorpseed
Clinical trials are critical in the development of novel medications and cures, advancing medical science and patient care. The clinical trial ecosystem in India has grown dramatically, making it an appealing destination for pharmaceutical research. This article explores the regulatory framework, ethical concerns, phases of clinical trials, application processes, review, post-approval requirements, obstacles, case studies, and future prospects of clinical trial approval in India.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible (able to be believed), accurate and that the rights, integrity and confidentiality of trial subjects are protected.
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
What is The Clinical Trial Approval Process In India.pdfPranshuCorpseed
Clinical trials are critical in the development of novel medications and cures, advancing medical science and patient care. The clinical trial ecosystem in India has grown dramatically, making it an appealing destination for pharmaceutical research. This article explores the regulatory framework, ethical concerns, phases of clinical trials, application processes, review, post-approval requirements, obstacles, case studies, and future prospects of clinical trial approval in India.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible (able to be believed), accurate and that the rights, integrity and confidentiality of trial subjects are protected.
Assignment on Regulatory Prespectives of Clinical TrialsDeepak Kumar
Assignment on Origin and Principles of International Conference on Harmonization - Good Clinical Practice, (ICH-GCP) guidelines Ethical Committee- Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
clinical protocol & investigator information.pptx by Nitin KaleNitinKale46
What is a clinical trial protocol?
Clinical research is conducted according to a plan (a protocol) or an action plan. The protocol demonstrates the guidelines for conducting the trial. It illustrates what will be made in the study by explaining each essential part of it and how it is carried out. An Investigator is selected by the sponsor to conduct a clinical trial. An Investigator should be qualified but they don’t necessarily need to be a physician, although a medical professional should be listed as a ‘sub-investigator if that is the case.
Significance and formalities of ethics committees for Clinical ResearchRaktimavaDasSarkar
Clinical research plays a pivotal role in advancing medical knowledge, developing
new treatments, and improving patient care. However, with these advancements
come ethical responsibilities to ensure the safety, dignity, and rights of research
participants are protected.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Assignment on Regulatory Prespectives of Clinical TrialsDeepak Kumar
Assignment on Origin and Principles of International Conference on Harmonization - Good Clinical Practice, (ICH-GCP) guidelines Ethical Committee- Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
clinical protocol & investigator information.pptx by Nitin KaleNitinKale46
What is a clinical trial protocol?
Clinical research is conducted according to a plan (a protocol) or an action plan. The protocol demonstrates the guidelines for conducting the trial. It illustrates what will be made in the study by explaining each essential part of it and how it is carried out. An Investigator is selected by the sponsor to conduct a clinical trial. An Investigator should be qualified but they don’t necessarily need to be a physician, although a medical professional should be listed as a ‘sub-investigator if that is the case.
Significance and formalities of ethics committees for Clinical ResearchRaktimavaDasSarkar
Clinical research plays a pivotal role in advancing medical knowledge, developing
new treatments, and improving patient care. However, with these advancements
come ethical responsibilities to ensure the safety, dignity, and rights of research
participants are protected.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
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
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.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
1. CLINICAL TRIAL STUDY TEAM
( Roles and Responsibilities)
PRESENTED BY
Bharat M. Patil
M . Pharmacy 1stYear(Department of Pharmacology)
R. C. Patel Institute of Pharmaceutical Education and Research,
Shirpur
2. ROLES AND RESPONSIBILITIE
INVESTIGATOR
COORDINATOR
SPONSOR
MONITOR
CONTRACT RESEARCH ORGANIZATION.
2
3. GLOSSARY
RESPONSIBILITIES
The opportunity or ability to act independently and take
decisions without authorization.
ROLE
A prescribed or expected behaviour
associated with a particular position
or status in a group, Organization.
CLINIC
A facility devoted to diagnosis and treatment or rehabilitation of
outpatients.
3
4. CLINICAL STUDY
Study specialized or therapeutic care that requires on going
assessment, planning, intervention And evaluation by health
care professionals.
TRIAL
A large number of participants, a small difference
between treatment and control groups may be statistically
significant
4
5. CLINICAL TRIAL
A controlled research study of the safety and effectiveness of
drugs, devices or techniques that occurs in four phases,
starting with the enrolment of a small number of people, to the
later stages in which thousands of people are involved prior to
approval by the licensing authority.
5
6. CLINICAL TRIAL STUDY TEAM
A clinical trial is a research study that tests a new medical
treatment or a new way of using an existing treatment to
see if it will be a better way to prevent and screen for
diagnose or treat a disease.
6
7. REQUIREMENT OF CLINICAL TRIAL STUDY TEAM
1. Sufficient study staff to perform clinical
research.
2. Appropriate skill set and training.
3. Follow GCP (Good Clinical Practice)
standard.
4. Follow protocol requirements.
7
8. RESEARCH TEAM ROLE
1. Ensure that ....
• The correct version of the protocol is
followed.
• Potential participants are provided with information.
• The Content of informed Consent form is properly stated.
8
9. • Protection of integrity and confidentiality of records and
data is taking Place.
2. Reporting of any failures in these respects or suspected
misconduct.
3. Report adverse incidents, events or drug reactions.
9
CONT…
10. RESEARCH TEAM RESPONSIBILITY
• Appropriate skill set and training.
• GCP (Good Clinical Practice) standards.
•Follow protocol requirements.
10
11. INVESTIGATOR
INVESTIGATOR =
An individual who conducts a clinical investigation or in the
event of an investigation conducted by a team of individuals,
is the responsible leader of the team.
CO-INVESTIGATOR =
A member of the research team designated and supervised by
the Protocol Investigation to perform critical study-related
procedures and to make important study-related decisions
sub-investigators as those individuals authorized to make
medical judgments and decisions regarding study subject
11
12. INVESTIGATORS' RESPONSIBILITIES
1. Conducting the trial ,statement, protocol, and
applicable regulations.
2. Protecting the rights, safety, and welfare of trial
participants.
3. Obtaining informed consent from all trial
participants.
12
13. 4. Maintaining proper records.
5. Managing all progress reports, safety reports, financial
disclosure reports.
13
6. Discussed in the Roles and Responsibilities module Based on
GCP guidelines.
7. Ensuring that the Investigational Product.
8. Used in accordance with the approved protocol.
CONT…..
14. INVESTIGATORS' ROLE
1. Interactions for applicable federal, state, and local
regulatory authority.
2. Follow ethical principles and standards.
3. Discipline in designing and conducting clinical
trials for policies, procedures.
14
4. Education programs are provided.
15. CONT….
6. Refer to Section Good Clinical Practice (GCP) Course for
training requirements.
7. The ultimate responsibility for the scientific, technical, and
administrative aspects of the research project.
15
16. STUDY-COORDINATOR
Coordinator Research Committee (CRC) also has a
critical role in facilitating, supporting and coordinating
daily clinical research study activities. The CRC works
under the direction of the PI who will delegate specific
clinical research study related tasks.
16
17. ROLE :
1. Conduct of a research study.
2. The CRC carries forward the research goals.
3. CRCs are often involved inessential duties that ensure
compliance with the protocol and protection of human
subjects.
4. Preparing the Institutional Review Board (IRB) submission.
17
18. CONT…..
5. writing the informed consent document,
recruiting and consenting participants.
6. coordinating and conducting study visits, adverse event
reporting, completing case report forms (CRF’s)
7. managing data and collecting biological specimens.
18
19. RESPONSIBILITIES
1. Complete the required of Course before initiation of
any clinical research related activity.
Human Research Protection Program(HRPP)
Collaborative Institutional Training Initiative (CITI)
2. Provide regulatory, institutional, sponsor and protocol
requirements for the study.
3. Complete with all IRB decisions, conditions and
requirements.
19
20. CONT…..
4. Ensure all studies have current IRB approval.
5. Coordinate with the PI and other key research personnel.
6. Ensure that Protected Health Information (PHI) will not be
disclosed to any parties.
20
21. SPONSOR
sponsor is an “individual ,organisation or partnership that
takes on overall responsibility for effective arrangements
being in place to set up, run and report on a research
project”.
21
ROLE OF SPONSOR
1. Financial –
2. Reputation
3. Legal
22. SPONSOR’S RESPONSIBLE :
• Selecting and providing qualified investigators.
• Ensuring proper monitoring of the investigation.
• Ensuring conducted in accordance with the plan
and protocols.
• Maintaining an effective respect to the investigation.
22
23. MONITOR
CLINICAL MONITOR
The person with direct access to patient’s medical records to
verify data and procedure acting with in the constraints of the
applicable regulatory requirement to maintain the confidentiality
of subjects' identities and sponsor’s proprietary information.
23
25. RESPONSIBILITY
• Assign to appropriate protocols.
• Review from activities as applicable.
• Review protocol rules.
•Advise protocol team on safety oversight.
25
• Evaluate and reviews safety reports.
• Assist with pharmacovigilance activities.
26. CONTRACT RESEARCH
ORGANIZATION
A Contract Research Organization (CRO) is a service
organization which provides various‖ pharmaceutical
research that is essential for conducting clinical trials
in the present various complications are involved in
the drug process.
26
27. ROLE
1. Project management.
2. Database design & build.
3. Data entry & validation.
4. Clinical trial data management.
5. Medicine and disease coding.
27
28. CONT…..
6. Quality and metric reporting.
7. Statistical analysis plans and reports.
8. Validation programming.
9. Safety and efficacy summaries.
10. Final study report.
28
29. 1. Evaluate feasibility.
2. Provide adequate, well manage staff.
3. Conduct study actives.
4. Manage processes.
5. Ensure that the solution are cost-effective.
RESPONSIBILITY
29
30. 1) World Health Organization, 2004. A glossary of terms for community health care and
services for older persons. WHO.2. (C) (1. Information about clinical trial. Available
from : URLhttp://www.temple.edu/pascope/about_trials.html ).
2) Thorat, S.B., Banarjee, S.K., Gaikwad, D.D., Jadhav, S.L. and Thorat, R.M., 2010.
Clinical trial: a review. Int J Pharm Sci Rev Res, 1, pp.101-6.
3) Carlos, R.A., 2017. Improving Faculty Participation in Student Conduct Hearing
Boards: A Gap Analysis (Doctoral dissertation, University of Southern California).
4) Roberts, B.L., Rickard, C.M., Foote, J. and McGrail, M.R., 2006. The best and worst
aspects of the ICU research coordinator role. Nursing in Critical Care, 11(3), pp.128-135.
5)https://www.fda.gov/downloads/training/cdrhlearn/ucm176457.pdf.
6)Read more:http://www.businessdictionary.com /definition /role.htm.l
7) National Drug Policy and Authority Act 2000 Edition
8) R. Sridhar*, Ch. V. Hemanth and N. Durga Deepak CLINICAL TRIALS AND ROLE OF
PHARMACIST
REFERENCE
30