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.
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.
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.
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
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
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
Clinical Trial Registration
International Clinical Trials Registry Platform (ICTRP)
What is the Primary Register?
Clinical Trial Registry - India (CTRI)
Goal and Objectives of the Registry
How to Register?
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
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
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
Clinical Trial Registration
International Clinical Trials Registry Platform (ICTRP)
What is the Primary Register?
Clinical Trial Registry - India (CTRI)
Goal and Objectives of the Registry
How to Register?
"Physiological Barriers" by Debanjan Chatterjee & Abhishek Roy Debanjan Chatterjee
Various Physiological barriers as a protective of drug , & their related Bio pharmaceutical action pharmacokinetic action the list of drugs and other relevant details
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.
The Tuskegee syphilis experiment was an infamous clinical study conducted between 1932 and 1972 by the U.S. Public Health Service to study the natural progression of untreated syphilis in rural African American men who thought they were receiving free health care from the U.S. government
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
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
Presentation working on clinical trialsSarah Henter
Working on Clinical Trials – Getting started
Very few clinical trials are conducted only in one country; many are available in a variety of different sites in different places, so the translation and linguistic adaptation for different target cultures and languages becomes more important – but it’s not easy to find professionals who specialize in this specific field. With my presentation I hope to provide an overview of what makes the linguistic work on clinical trials so special, what kind of texts and target audiences there are and what knowledge linguists need to acquire in order to efficiently work in this area. This is especially interesting for translators who already specialize in the medical field, but also for linguists interested in legal, business, marketing and related field who would like to add an interesting niche with high demand to their specialization.
The presentation aims to be an introduction to the characteristics and requirements of the linguistic work on texts related to clinical trials. It not only wants to give a brief overview of how clinical trials work and who the stakeholders are, but also underline the skills and knowledge set linguists who would like to further specialize in this field should acquire. It also provides them with the necessary resources to get them started. The main topics are as follows:
• Introduction to clinical trials (what are they; how do they work; who is implied)
• Types of documents used in clinical trials (medical [specialist facing/ patient facing]; legal; marketing, etc.)
• Types of audiences (doctors/investigators/healthcare providers; patients/ other laymen such as healthy subjects/ partners/ legal representatives/ parents, etc.; ECs; CROs…)
• What skills do linguists need to work in this field?
• How to acquire that knowledge?
- Where to find glossaries/ templates/ further information
- MOOCs to take to get you started
- Books you should have read
- Other handy resources
Investigators Responsibilities during Clinical trialsBHAVYARAJAN2
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
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
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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.
2. Agenda
• What is ICH & GCP
• Principles of ICH & GCP
• IRB & IEC
• Investigator
• Sponsor
• Clinical trial Protocol
• Investigator brochures & Essential documents
3. What is ICH & GCP
“The International Conference on Harmonization -
Technical Requirements for Registration of
Pharmaceuticals for human use.”
Unifying regulatory authorities & pharmaceutical
industry
Geographies - Europe, Japan and the US
Discuss scientific and technical aspects of drug
registration.
4. GCP – Good Clinical Practices
“International quality standard that is provided by ICH”
Ethical and Scientific quality standard
For designing , conducting, recording and
reporting trials
Provides public assurance that the rights, safety,
confidentiality and wellbeing of trial subjects are protected
Consistent with the principles of the Declaration of
Helsinki (developed by World medical Association)
It’s a statement of ethical principles for medical research
involving human subjects, including research on
identifiable human material and data
5. Principles of ICH-GCP
Ethical Principles-Applicable regulatory
requirements
Foreseeable risks Vs. Anticipated benefits
Adequate clinical & non clinical information of
an investigational product
Trial should be in compliance with the protocol
that received prior approval from IRB & IEC
6. Principles of ICH-GCP contd.
Medical decisions – Qualified physician
Personnel Conducting trials – Qualified by education, training &
experience
Freely given ICF from every subject prior to trial participation
Investigational product –GMP practice – quality assurance
All information- recorded, handled, and stored that allows
accurate reporting, interpretation & verification
7. IRB & IEC
IRB- Institutional Review Board is an independent
body constituted of medical, scientific & non scientific
members
IEC-Independent Ethics Committee (A review
board/committee/regional/national) an independent
body constituted medical/non medical members
Responsible to ensure protection of rights, safety &
wellbeing of human subjects involved in a trial
IRB/IEC should obtain following documents-trial
protocol(s) amendments, Written ICF, Advertisements,
Investigator brochure, payment info & CV of
investigator.
8. IRB & IEC
Composition & Functions
At least 5 members(1 member-non scientific area & 1 member
independent of the institution/trial site)
Perform its function according to written operating procedures.
Review a proposed trial in a reasonable time and document its
view.
Approval/Modification/disapproval/termination
Should comply with GCP & applicable regulatory requirements
Notification in writing trial related decisions, reasons, procedures,
for appeal
Retain trial records for 3 years
9. Investigator
Responsible for the conduct of the clinical trial qualified by
education, training, & experience.
Thoroughly familiar with correct use of investigational products
described in protocol
Aware of & comply with GCP & applicable regulatory requirements
Adequate resources
Medical care of the trial subjects
Communication with IRB/IEC
Compliance with protocol
Investigational product(s)
Randomization procedures/ unblinding
10. Informed consent -process
In obtaining & documenting informed consent, investigator
should comply with applicable regulatory requirement(s),
adhere to GCP
Prior approval from IRB/IEC
Neither investigator nor trial staff coerce or unduly
influence the subject to participate in the trial.
Language used in written ICF should be non technical,
practical & understandable in their own language.
If both the subject and their legally accepted
representative are unable to read, an impartial witness
should be present during discussion.
11. Informed consent discussion
Purpose of trial
Trial treatments & procedures
Subject’s responsibilities, Foreseeable risks/in
conveniences
Alternative procedure/treatment, Compensation/treatment
in event of trial related injury
Voluntary participation
Prior to participation in trial, subject should receive a copy
of signed and dated written IC form
12. Records & reports
Accuracy, completeness, legibility & timeliness of data
Data reported on CRF that are derived from source documents
should be consistent
Any correction to a CRF should be dated, initiated and explained
Essential documents should be retained until at least 2 years
Submission of trial status, All SAE,s should be reported immediately
to IRB/IEC
Premature termination promptly informed to sponsor, IRB/IEC
Final reports- A summary of trial outcome
14. Monitoring
The act of overseeing the progress of a clinical trial, and of ensuring that it is:
Conducted
Recorded
And reported
In accordance with
The protocol
Standard operating procedures (SOP’S)
Good clinical practice (GCP) and
Applicable regulatory requirements
Trial monitoring is an integral component of trial quality assurance process, and critical for
GCP fulfillment.
15. Monitor’s Responsibilities
Ensure that the trial is conducted and documented properly
Acting as the main line of communication between sponsor and
investigator
Verifying
The investigator’s qualification
Investigational products
Following the approved protocol
ICF, Investigator’s brochure,
Source documents, trial records are accurate, complete, timely,
legible, dated, accuracy & completeness of the CRF
16. Audit
“A Systematic and independent examination of trial
related activities and document to determine”
Whether the evaluated trial related activities were
conducted
The data were recorded, analyzed, & accurately
reported according to the protocol, sponsor SOP’S,
GCP, applicable regulatory requirements
Purpose of a sponsor’s audit is to evaluate the trial
conduct & compliance with quality systems & SOPs
,protocol, and GCP.
17. What to Audit?
Organization and personnel
Qualification, training, & adequacy of staff
List of monitors
Quality management systems
Investigational drug
IRB/IEC
Investigators & sub investigators
Essential documents
18. Clinical trial Protocol
General &
Background
info
Objective
Protocol
Trial design
Selection &
Withdrawal
of subject
Treatment
Record
keeping
Safety
Quality
control
assessment
20. Essential documents
Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of
the data produced.
Documents are grouped in to three sections
1. Before the clinical phase of the trial commences
2. During the clinical conduct of the trial
3. After the completion or termination of the trial
21. Before trial During the trial After trial completion
IB, Signed protocol &
IB updates, Any
amendments
revision(protocol)
Investigational products
accountability
ICF
Advertisement
IRB/IEC Approval Documentation of IP
destruction
Financial aspects Regulatory authority
notifications
Subject identification
code list
Insurance aspects updates of CV Audit certificate
Signed agreement Updates of lab values Final trial closeout
monitoring report
IRB IEC approval Monitoring visit reports Treatment allocation &
decoding documentation
CV /Qualifications Signed ICF, Source
documents
Final report by
investigator to IRB/IEC,
regulatory authorities
22. Before trial During the trial After trial completion
Bio medical values Signed dated completed
CRF
Clinical study report
Medical/lab tests Notification of AE,SAE
Handling Investigational
products, shipment
Subject screening log,
identification code list
Investigational products
accountability
Pre trial monitoring, trial
initiation report
Interim/annual reports to
IRB/IEC
23. References
www.ich.org
ICH Topic E6(R1)- Guideline for good clinical practice
www.ppdi.com
www.clininvent.com
www.emaeuropa.eu
Apps.who.int