The document discusses the roles and responsibilities of key members of a clinical research team. It describes the investigator as the leader responsible for ensuring ethical and protocol-compliant conduct of the study. The clinical research coordinator supports the investigator and manages daily trial activities including participant communication and data collection. The sponsor initiates and finances the study, while maintaining responsibility for quality and integrity. A contract research organization may take on some sponsor responsibilities by agreement.
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.
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...Dinesh Gangoda
Contents
Guidelines for Preparation of Documentation
Clinical Study Reports
Clinical Trial Monitoring
Safety Monitoring in clinical trials
Introduction
Proper documentation is critical to the success of a clinical study.
Every aspect of the study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and with all applicable regulations.
Investigator’s Brochure (IB)
List of Abbreviations
Contents & Summary
Introduction provides the chemical name (and generic and trade names, if approved) of the investigational product.
Physical, chemical and pharmaceutical properties and formulation of the medicinal product. Non-clinical studies & Clinical Studies and their results.
The Investigator's Brochure should be reviewed at least annually and revised as necessary in compliance with a standard procedures established by drug development company.
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.
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
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.
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...Dinesh Gangoda
Contents
Guidelines for Preparation of Documentation
Clinical Study Reports
Clinical Trial Monitoring
Safety Monitoring in clinical trials
Introduction
Proper documentation is critical to the success of a clinical study.
Every aspect of the study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and with all applicable regulations.
Investigator’s Brochure (IB)
List of Abbreviations
Contents & Summary
Introduction provides the chemical name (and generic and trade names, if approved) of the investigational product.
Physical, chemical and pharmaceutical properties and formulation of the medicinal product. Non-clinical studies & Clinical Studies and their results.
The Investigator's Brochure should be reviewed at least annually and revised as necessary in compliance with a standard procedures established by drug development company.
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.
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
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
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigational New Drug Application (IND) program based on the survey conducted by the Office Of Inspector General (OIG).
Safety pharmacology is a branch of pharmacology with its aim to predict the potential clinical risk profile of new chemical entities (NCEs).
It has the ability to predict the potential off-target drug effects on major organ systems which are associated with exposure in the therapeutic range and above.
As an essential part of the spectrum of drug discovery and development, safety pharmacology studies are generally conducted to determine the relative drug effect on main organs, including respiratory system, central nervous system, and cardiovascular system.Safety pharmacology is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials.
SP studies are described in the international conference on harmonization (ICH) S7A and S7B Guidelines.
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
The basic aspects of drug discovery starts from target discovery and validation further going to lead identification and optimization. In this particular slide discussion is regarding the target discovery and the tools that have been utilized in this process.
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
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigational New Drug Application (IND) program based on the survey conducted by the Office Of Inspector General (OIG).
Safety pharmacology is a branch of pharmacology with its aim to predict the potential clinical risk profile of new chemical entities (NCEs).
It has the ability to predict the potential off-target drug effects on major organ systems which are associated with exposure in the therapeutic range and above.
As an essential part of the spectrum of drug discovery and development, safety pharmacology studies are generally conducted to determine the relative drug effect on main organs, including respiratory system, central nervous system, and cardiovascular system.Safety pharmacology is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials.
SP studies are described in the international conference on harmonization (ICH) S7A and S7B Guidelines.
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
The basic aspects of drug discovery starts from target discovery and validation further going to lead identification and optimization. In this particular slide discussion is regarding the target discovery and the tools that have been utilized in this process.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
Sponsor monitoring in clinical research refers to the oversight and supervision conducted by the sponsor or sponsor's representative throughout the course of a clinical trial. The purpose of sponsor monitoring is to ensure the rights, safety, and well-being of study participants, as well as the quality and integrity of the trial data. Here are some key aspects and considerations related to sponsor monitoring in clinical research
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.
Good clinical practice and its principlesFomat Medical
FOMAT Medical Research is the owner of elite sites throughout USA that is specialized in the effective management of research sites. We have a network of more than 10 million patients and the professionals who are well aware of the good clinical practices, which helps us in running successful trials.
https://www.fomatmedical.com/2014/03/reasons-run-clinical-trials-latin-america-region/
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
2. The Research team
Need sufficient study staff to perform clinical research .
Appropriate skill set and training.
GCP (Good clinical practice ) standards.
Follow protocol requirements.
3. 1. INVESTIGATOR
2. CLINIC RESEARCH COORDINATOR(CRC)
3. SPONSOR
4. CONTRACT RESEARCH ORGANIZATION (CRO).
RESEARCH TEAM RESPONSIBILITY
Appropriate skill set and training.
GCP (Good Clinical Practice) standards.
Follow protocol requirements.
4. A investigator is the person who holds the responsibility for execution of
clincal research.
The investigator leads the research at the research site . It is the prime
responsibility of investigator to ensure that the study is conducted in
accordance with protocol, GCP and relevant regulations, and rights, safety
and well being of research subjects as well protected during the research.
As a leader investigator deligates research related tasks to other research
staff. But he or she must oversight each and every deligated task even after
deligating the task to others.
Investigator should should be well versed with:
ICH-GCP guidelines
Applicable regulatory requirements
5. Study protocol is scientifically sound and particular study has scientific and
social value.
All required approvals are taken before commencing research.
Helps in site selection; investigator varifies that there are adequate resources
such as time, funding, manpower, infrastructure etc.
Maintaining oversight for overall study activities and tasks delegated to
research staff and other invoved parties at site.
Investigator ensure that informed consent process is done properly. All
research participants are made well aware about all aspects of research
including risks and benefits of research.
Investigator needs to ensure that all participants are properly treated and
they are happy during research period.
If any changes in study protocol investigator needs to get approval for the
change from ethics committee, research participants need to be informed
about changes made in protocol.
6. Investigator needs to ensure that all research participants are adhering to
give research related instruction such as site visits, taking medicine etc.
Investigator ensure that all kinds of reporting (eg. adverse reaction
reporting) are done in a defined timeline to concerned partners.
Data and study records are stored, retained and protected in accordance
with prescribed guidelines and relevant regulations.
Ensures that handling of investigational product is properly done.
Medical assessments, efficacy evaluation of investigational product and
determining therapy relationship with adverse events etc.
Investigator allows smooth inspection and audits they also ensure that
quality and integrity of clinical data is mantained.
Analyses of clinical data are done according to pre-planned protocol
analysis plan and in accordance with accepted statistical principles
At end of study all the reports are prepared with accurate data for further
submission.
Selection of investigator :-
education, Training, Experience
7. Clinical research cordinator is also known as study cordinator. Playes virtal
role in clinical research project.
Study cordinator works under principle investigator and supports the
management and cordinates in daily trial activites.
CRC gets involve since inception of result and continous still the completion
of the project.
Number of CRC in trial depends on workload at trial site.
CRC consider as heart of clinical trial.
8. Research cordinator plays an integral role in conduct of research.
They are responsible for developing implementing and coordinating trial
procedure for successful management.
They work in cordination with a principle investigator and various
department to ensure that the research is conducted in ethical manner and in
accordance with prescribed SOP guidelines and applicable regulatory
regulation.
They ensure the safety and protection of human subjects in clinical trial .
They work very closely with the participants and they have to do lots of
intraction with participants such as – Educating volunteers regarding trial,
Administrating medication to patient, Collecting correct data from the
patient etc.
CRC must have knowledgeabout all aspects of clinical trial because they are
involved in various activities of trial such as- participants screening informed
consent process scheduling of participant visits etc.
During site finalizaation they play an important role as communicator
between the investigator and the sponsor or CRO.
9. CRC prepare budget for study and look into various collaborations with
funding agencies.
During clinical trial it is responsibility CRC to check all the lab reports and to
ensure these reports are reviwed and signed by investigator.
If any adverse event or serious adverse event has occurred at trial site, it is
the responsibility of study cordinator to inform the sence with all the details
to appropriate departments and committee with define time line.
Before a clinical trial is closed at the site clinical research cordinators have to
ensure that all documents are checked properly and updated, after
varification of all documents by research associate .CRC will suport in proper
occuring of the documentsat the site .
Study cordinator are rsponsible for reporting outcomes to all stakeholders.
CRCs are involved in conducting research and managing various roles of
research project such as-
Planing and management of the study
Obtaining grants for clinical research
Recruitment and screening of participants
Monitoring trial procedures
Maintaining proper documentation
Ensuring safety and wellbeing of participants are maintained
Taking care of training activites
Maintaining compliance regulations guidelines and ethics etc.
10. Sponsor is one who take the responsibility to initiate, finance, manage
clinical trial.
The sponsor can be-
an individual
Pharmaceutical company
Government agency
Academic institution
Private or other organisation.
Sponsor do not conduct the trial but they ultimately responsible for the
quality and integrity of the clinical trial.
Thus they carry no. of responsibility in order to complete the trial
successfully and obtaining meaningful outcome.
11. The sponsor should ensure that all aspects of the trail are operationally
feasible .
They should look into risk aspects involved in trial.
They need to makesure that enough preclinical data and other relevant data
is available to start trial in human.
Sponsor may transfer some any or all of sponsors trial related duties and
function to CRO, however sponsor hold the responsibility of quality and
integrity of a trial data.
Sponsor need to invovled well trained experience individuals in a trial to
perform all the trial activites (data management, site selection, data
analysis,planning and designing of trial etc.) smoothly and successfully.
For example- Physician
Data manager
Administrator
Biostatistician
12. Before intiating or during clinical trial sponsor need to ensure that all reviews
are done and permission are granted by appropriate authorities for all trial
activities.
Keeping check on shipment, handling, storage, administration return and
disposal of investigational product or other medicinal product or device used
during trial.
Sponsor should report all the new information arising during the trial to all
the concerned parties such as – Ethics committee, Health authority etc.
Sponsor need to ensure that protocol and any other amendments are being
followed.
It is the responsibility of sponsore to makesure that all research personnel
are well trained according to required regulations and ICH-GCP guildlines.
13. according to ICH-GCP guidelines:-
CRO is a person or an organization (commercial, academic, or other)
contracted by the sponsor to perform one or more of sponsor’s trial- related
duties and function.”
CRO can support sponsor companies right form preclinical development of
new products till post marketing research activites.
CRO are well equipped with various facilities and have experties for
conducting research related activities.
CRO is able to support all activites related to a product life cycle right from
the project initiation up to post marketing surveillance activities.
Survicies provided by CRO include-
Project initiation
Producr development
Pre-clinical research
Clinical research
Regulatory submission
Post marketing surveillance
14. Duties of sponsor and CRO should be listed down in the beginning of the
outsourcing process and both the parties must stick to the defined duties. All
the involved personal should be well aware of their roles and responsibilities.
CRO must abide by contract signed with the sponsor.
CRO needs to ensure that all clinical trial activities are conducted in
according to applicable regulations and guidelines.
CRO should commicate the concerned matters to sponsor in a timely
manner. They should do proper documentation for all the activities.