This Presentation was presented by Pruthvi raj, Tejaswini, and myself Bhavya Rajan at Clinosol Research Pvt Ltd. We would like to thank Clinosol and Mujeeb sir for this opportunity. for constantly supporting and encouraging us
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
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
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
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
In this PPt contain the E6 R1 and E6 R2 information , and the GCP training material for the Good prectice. and end of the ppt there is a ink which is use for your online training and generate certificate.
Role responsibilities of_a_clinical_research_coordsushant deshmukh
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Every clinical research project may have one or more study coordinators depending on the workload at the trial site. Clinical trials at site level can be roughly divided into 3 stages. The three stages and the role of the coordinators at these stages are:
1) Before starting the clinical trial
2) During the conduct of the clinical trial
3) After finishing the clinical trial
1) Before starting the clinical trial:
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.
Essential Documents For the Conduct of Clinical TrialClinosolIndia
The conduct of a clinical trial involves the generation and maintenance of various essential documents to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. These documents serve as a record of the trial and provide evidence of the study's conduct, integrity, and participant protection. Here are some essential documents commonly required for the conduct of a clinical trial
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.
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.
Investigators play a crucial role in conducting clinical research studies and ensuring the integrity, safety, and ethical conduct of the trials. Here are some key responsibilities of investigators in clinical research
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
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
In this PPt contain the E6 R1 and E6 R2 information , and the GCP training material for the Good prectice. and end of the ppt there is a ink which is use for your online training and generate certificate.
Role responsibilities of_a_clinical_research_coordsushant deshmukh
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Every clinical research project may have one or more study coordinators depending on the workload at the trial site. Clinical trials at site level can be roughly divided into 3 stages. The three stages and the role of the coordinators at these stages are:
1) Before starting the clinical trial
2) During the conduct of the clinical trial
3) After finishing the clinical trial
1) Before starting the clinical trial:
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.
Essential Documents For the Conduct of Clinical TrialClinosolIndia
The conduct of a clinical trial involves the generation and maintenance of various essential documents to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. These documents serve as a record of the trial and provide evidence of the study's conduct, integrity, and participant protection. Here are some essential documents commonly required for the conduct of a clinical trial
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.
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.
Investigators play a crucial role in conducting clinical research studies and ensuring the integrity, safety, and ethical conduct of the trials. Here are some key responsibilities of investigators in clinical research
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
The presentation on ICHGCP guidelines overview.The presentation gives a detailed view of What is ICHGCP, Principles of ICH & GCP
IRB & IEC, Investigator, Sponsor, Clinical trial Protocol
Investigator brochures & Essential documents.
This presentation focuses on Institutional Review Board/ Institutional Ethics Committee, Informed Consent Form and Protocol for a Research. The responsibilities of various personals have also been covered.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
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CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
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Cold Sores, medically known as herpes labialis, are caused by the herpes simplex virus (HSV). HSV-1 is primarily responsible for cold sores, although HSV-2 can also contribute in some cases.
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Explore the groundbreaking work of Dr. David Greene, a pioneer in regenerative medicine, who is revolutionizing the field of cardiology through stem cell therapy in Arizona. This ppt delves into how Dr. Greene's innovative approach is providing non-surgical, effective treatments for heart disease, using the body's own cells to repair heart damage and improve patient outcomes. Learn about the science behind stem cell therapy, its benefits over traditional cardiac surgeries, and the promising future it holds for modern medicine. Join us as we uncover how Dr. Greene's commitment to stem cell research and therapy is setting new standards in healthcare and offering new hope to cardiac patients.
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Dr. David Greene R3 stem cell Breakthroughs: Stem Cell Therapy in CardiologyR3 Stem Cell
Dr. David Greene, founder and CEO of R3 Stem Cell, is at the forefront of groundbreaking research in the field of cardiology, focusing on the transformative potential of stem cell therapy. His latest work emphasizes innovative approaches to treating heart disease, aiming to repair damaged heart tissue and improve heart function through the use of advanced stem cell techniques. This research promises not only to enhance the quality of life for patients with chronic heart conditions but also to pave the way for new, more effective treatments. Dr. Greene's work is notable for its focus on safety, efficacy, and the potential to significantly reduce the need for invasive surgeries and long-term medication, positioning stem cell therapy as a key player in the future of cardiac care.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
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International Cancer Survivors Day is celebrated during June, placing the spotlight not only on cancer survivors, but also their caregivers.
CANSA has compiled a list of tips and guidelines of support:
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DECODING THE RISKS - ALCOHOL, TOBACCO & DRUGS.pdfDr Rachana Gujar
Introduction: Substance use education is crucial due to its prevalence and societal impact.
Alcohol Use: Immediate and long-term risks include impaired judgment, health issues, and social consequences.
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2. 1. Investigator’s Qualifications and Agreements
2. Adequate Resources
3. Medical Care of Trial Subjects
4. Communication with IRB/IEC
5. Compliance with Protocol
6. Investigational Product(s)
7. Randomization Procedures and Unblinding
8. Informed Consent of Trial Subjects
9. Records and Reports
10.Progress Reports
11.Safety Reporting
12.Premature Termination or Suspension of a Trial
13.Final Report(s) by Investigator
CONTENT
3. Who can be an investigator in clinical trial ?
An investigator…
is a qualified physician who is responsible for all trial-related medical decisions
must have suitable education, training and experience in the field being researched
and also have a knowledge of GCP and applicable regulatory requirements
should permit monitoring and auditing by the sponsor, and inspection by the
appropriate regulatory authority(ies)
If a trial is conducted by a team of individuals at a trial site, the Investigator is the
responsible leader of the team and may be called the principal Investigator.
Sub-Investigator: a member of Clinical trial team, designated and supervised by
principal Investigator to perform trial related duties and functions.
5. INVESTIGATOR’S QUALIFICATIONS AND AGREEMENTS
should be qualified by
education, training, and
experience
meet all the qualifications
specified by the applicable
regulatory requirement(s)
with evidence
Familiar with
o Protocol,
o Investigational Brochure
o Investigational Product
Aware of and comply .with
GCP’s and applicable
regulatory requirements.
permit monitoring and
auditing by the sponsor, and
inspection by the
appropriate regulatory
authority(ies)
List of Qualified persons
who are delegated trial
related duties.
7. Adequate Resources
Recruit number of
suitable subjects within
the agreed recruitment
period
Having sufficient time to
conduct and complete
within the agreed trial
period
Arrange adequate number
of qualified staff and
facilities for the duration of
the trial to conduct the trial
properly and safely
Ensure that all persons
assisting with the trial are
adequately informed about
the protocol, investigational
products and their trial
related duties and function
9. MEDICAL CARE OF TRIAL SUBJECTS
Ensure that adequate medical care is provided to a
subject for any adverse events, including clinically
significant laboratory values
Inform a subject when medical care is needed for
intercurrent illness(es)
Inform the subject’s primary physician about the
subject’s participation
Although a subject is not obliged to give his/her
reason(s) for withdrawing prematurely from a trial, the
investigator should make a reasonable effort to
ascertain the reason(s), while fully respecting the
subject's rights.
11. COMMUNICATION WITH IRB/IEC
Before initiating a trial investigator should have: written and dated
approval/favorable opinion from the IRB/IEC for the
Trial protocol
written informed
consent form
consent form
updates
subject recruitment
procedures & other written
information to be provided to
subjects
Investigator should provide current and updated { if made } copy of
investigator brochure to IRB/IEC
During the trial the Investigator should provide to the IRB/IEC all documents
subject to review.
13. COMPLIANCE WITH PROTOCOL
Conduct the trial in compliance with the protocol agreed by sponsor and Regulatory
authorities and sign the protocol, or an alternative contract, to confirm agreement.
Should not implement any deviation from protocol without agreement by the
sponsor and prior review.
EXCEPT…. In emergency where necessary to eliminate immediate hazard to trial
subjects or if change involves only logistical or administrative aspect of the trial
( eg. Change of monitor or change of telephone Numbers)
Person designated by the Investigator, should document and explain any deviation
from the approved protocol.
As soon as possible, the implemented deviation or change, the reasons for it, and, if
appropriate, the proposed Protocol amendment(s) should be submitted to sponsor,
IRB/IEC and regulatory authorities
15. INVESTIGATIONAL PRODUCT(S)
MAINTAIN
RECORDS
Should maintain records of the
product's
delivery to the trial site
inventory at the site
use by each subject
the return to the sponsor
or
alternative disposition of
unused product(s).
STORAGE
Should be stored as specified by
the sponsor and in accordance
with applicable regulatory
requirement(s).
The investigator, or a person
designated by the investigator, should
explain the correct use of the
investigational product(s) to each
subject and should check, at intervals
appropriate for the trial, that each
subject is following the instructions
properly.
ENSURE
The investigator should ensure
that the investigational product(s)
are used only in accordance with
the approved protocol.
EXPLAIN /
CHECKING
17. RANDOMIZATION PROCEDURES AND UNBLINDING
The investigator should follow the trial's randomization
procedures, if any, and should ensure that the code is broken
only in accordance with the protocol.
If the trial is blinded, the investigator should promptly
document and explain to the sponsor any premature
unblinding (e.g., accidental unblinding, unblinding due to a
serious adverse event) of the investigational product(s)
19. INFORMED CONSENT OF TRIAL SUBJECTS
While obtaining and documenting Informed consent,
Investigator must -
Comply with Regulatory Requirements
Adhere to GCP
Ethical principles from Declaration of Helsinki
Prior to trial, investigator should have IRB/IEC’s
written approval of-
Written Informed consent form/ revised ICF
For any other written information shared with
subjects
Communication of revised ICF should
be documented
No one should unduly force subject
for participation
Ample time for enquiring about trial &
all questions should be
answered
20. -
Language
•Non- technical
•that appears to waive legal rights of subject or
release organizations/ people involved in CT
from liability of negligence should NOT be
used
Legally Acceptable
Representative(LAR)
•Incase, subject is unable to give informed
consent, investigator informs all the aspects
of trial to LAR
•Eg. Minors, Patient with dementia etc
Impartial Witness
•Incase, Subject/LAR unable to read
•Signs ICF after Subject/LAR has given oral
consent and if possible personally signed and
dated
•By signing ICF, Impartial witness attests that
all information was accurately explained &
understood by Subject/LAR
Prior to participation, Subject/LAR should
receive a copy of ICF; any other written
Information
and during participation copy of updated
ICF ; any amendments in written
information provided
Subjects who are enrolled after consent
of LAR, should be informed about trial to
extent of their understanding
ICF continued..
23. - Non-therapeutic trial should be conducted only in subjects who can personally give consent, except in
these situations.
- Also, subjects should be closely monitored and withdrawn if they appear unduly distressed.
When objectives of trial cannot be met with such subjects
Foreseeable risks in subject are low
Negative impact on subjects well being is minimized or low
Trial is not prohibited by law
Approval of IRB/IEC is expressly sought for inclusion of such subjects
24. Emergency
situation, and
Subject’s
consent not
possible
LAR present Take consent
LAR absent
Measures prescribed in Protocol
Documented approval of IRB/IEC to
protect the rights, safety & well being of
patients
Ensure Compliance with regulatory
requirements
Inform Subject/ LAR as soon as possible
ICF continued..
26. RECORDS AND REPORTS
The source documents and trial
records should be maintained
with adequacy and accuracy by
the investigator
Data reported to the sponsor
in the CRF, that are derived
from source documents,
should be consistent with the
source documents
Any change or correction to a
CRF should be dated, Initialed
and explained and should not
obscure the original entry(i.e.
Audit trail should be
maintained)
The Investigator should maintain
the trail documents as specified
in the Essential documents for
the conduct of a clinical trail.
Measures should be taken to
prevent accidental or premature
destruction of these documents
The financial aspects of the
trail should be documented
in agreement with the
sponser and Investigator.
28. PROGRESS REPORTS
Status Report
Submit written summaries
of the trial status to the
IRB/IEC annually, or more
frequently, if requested by
the IRB/IEC.
Risk Report
Should promptly provide written reports to
the sponsor, the IRB/IEC and, where
applicable, the institution on any changes
significantly affecting the conduct of the
trial, and/or increasing the risk to subjects.
30. SAFETY REPORTING
All serious adverse events (SAEs)
should be reported immediately to
the sponsor
EXCEPT
for those SAEs that the protocol or
other document (e.g., Investigator's
Brochure)identifies as not needing
immediate reporting.
The immediate and follow-up
reports should identify subjects
by unique code numbers
assigned to the trial subjects.
Should follow regulatory
requirements should report
unexpected SAE’s to regulatory
authorities
Identified abnormalities & SAE’s in the
protocol which are critical to safety
evaluations should be reported within the
time periods specified by the sponsor in
the protocol.
For reported deaths, the Investigator should supply the sponsor and the
IRB/IEC with any additional requested information (e.g., autopsy
reports and terminal medical reports).
32. PREMATURE TERMINATION OR
SUSPENSION OF A TRIAL
If the investigator
terminates or suspends a
trial without prior
agreement of the sponsor
If the sponsor terminates or
suspends a trial
If the IRB/IEC terminates or
suspends its
approval/favourable
opinion of a trial
The investigator should inform the
institution where applicable, and the
investigator should promptly inform
the sponsor and the IRB/IEC, and
should provide the sponsor and the
IRB/IEC a detailed written
explanation of the termination or
suspension.
The investigator should promptly
inform the institution where
applicable and the investigator
should promptly
inform the IRB/IEC and provide
the IRB/IEC a detailed written
explanation of the
termination or suspension.
The investigator should inform
the institution where applicable
and the investigator should
promptly notify the sponsor and
provide the sponsor with
a detailed written explanation of
the termination or suspension.
34. FINAL REPORT(S) BY INVESTIGATOR
should inform the
institution
should provide the
IRB/IEC with a
summary of the
trial’s outcome
should provide the
regulatory
authority(ies) with
any reports required.
COMPLETION OF TRIAL