The document provides an overview of ICH GCP (International Council for Harmonisation Good Clinical Practice) guidelines. ICH GCP guidelines were developed to harmonize clinical trial standards and processes across regions. They establish international ethical and scientific quality standards for designing, conducting, and reporting clinical research involving human subjects. Adherence to ICH GCP provides public assurance that the rights, safety, and well-being of clinical trial subjects are protected.
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
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
“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”.
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
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
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
“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”.
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
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.
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.
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
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.
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
Choice of control group in clinical trialsNagendra SR
To describe the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss related trial design and conduct issues.
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.
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.
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
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.
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
Choice of control group in clinical trialsNagendra SR
To describe the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss related trial design and conduct issues.
Introduction
Historical background
Sections
Principles
Ethics committee
Responsibilities of sponsor, investigator and monitor
Investigator brochure
Informed consent process
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines provide internationally recognized standards for the design, conduct, monitoring, recording, analysis, and reporting of clinical trials involving human subjects. These guidelines aim to ensure that the rights, safety, and well-being of trial participants are protected and that the clinical trial data generated is credible and reliable.
Key components of the ICH-GCP guidelines include:
Investigator Responsibilities: The guidelines define the responsibilities of the investigator, who is typically a qualified physician overseeing the conduct of the trial at a study site. This includes ensuring that the trial is conducted in compliance with the protocol, maintaining the confidentiality of participant data, and reporting adverse events and other relevant information promptly.
Ethics Committee/Institutional Review Board (IRB) Oversight: The guidelines stress the importance of independent ethics committees or IRBs in reviewing and approving the trial protocol, providing ongoing oversight, and protecting the rights and well-being of trial participants.
Informed Consent: The guidelines emphasize the importance of obtaining informed consent from each trial participant. Informed consent is a process that involves providing participants with relevant information about the trial, its purpose, potential risks and benefits, and any alternative treatments, enabling them to make an informed decision about participation.
Safety Reporting: The guidelines outline procedures for monitoring and reporting adverse events and any other safety concerns that arise during the course of the trial. Safety reporting ensures that potential risks to participants are identified and communicated appropriately.
Data Integrity: The guidelines emphasize the need for accurate and reliable data collection, recording, and reporting. This includes maintaining source documents and case report forms, as well as implementing data quality control measures.
Quality Assurance and Quality Control: The guidelines highlight the importance of quality assurance and quality control measures to ensure that the trial is conducted in compliance with the protocol, applicable regulations, and Good Clinical Practice.
Monitoring of Clinical Trials: The guidelines stress the need for systematic monitoring of the trial's progress to ensure that it is conducted in compliance with the protocol, applicable regulations, and Good Clinical Practice. Monitoring activities may include on-site visits, source data verification, and assessment of trial conduct.
..
Overall, the ICH-GCP guidelines provide a framework for the ethical and scientific conduct o
ICH GCP guidelines for mpharmacy 2nd sem 204T subject.
topic include the brief description regarding ICH GCP
THE GOOD CLINICAL PRACTICES AND
THE INTERNATIONAL CONFERENCE OF HORMONIZATION.
THAT INCLUDE the regulation of all pharmaceutical industries.
1. Overview of ICH GCP Syed Sarfaraz Uddin e-mail: syed.sarfaraz.uddin@gmail.com
2.
3.
4.
5.
6.
7.
8.
9.
10. The ICH Story Through the development of science-based, international guidelines and standards How: Reduce unnecessary duplication and thereby contribute to the efficiency of drug development and registration for new pharmaceuticals Why: Regulatory authorities and research-based industry of the EU, US and Japan; WHO, EFTA and Canada observers Who:
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31. ETHICAL REVIEW SHOULD DEFINE JUSTIFIABLE BOUNDARIES BETWEEN THE RIGHTS OF THE SUBJECT AND THE BENEFITS THAT MIGHT ACCRUE TO SOCIETY THROUGH SCIENTIFIC INFORMATION DEVELOPED IN CLINICAL TRIALS. Regulations have been established internationally, to ensure ethical & scientific conduct of trials
32.
33. STAKEHOLDERS & THEIR RELATIONSHIPS MONITOR DATA SUBJECT REGULATORY AUTHORITY SPONSOR ETHICS COMMITTEE INVESTIGATOR
Helsinki declaration was adopted by World Medical Assembly in 1964, amended in Tokyo in 1975, in Venice in 1983 and subsequently in Hong Kong in 1989. The most important principle being “Interests of the subject must always prevail over the interests of science and society.” However, this declaration does not necessitate informed consent for therapeutic trials and only requires documentation of reasons for not obtaining the same. The physician is obliged to preserve the accuracy of the results. Thus GCP ensures the credibility of the data.
Most of the current requirements of ethical protection are as a result of reaction by the public, scientific community and politicians in response to reports of abuse of trial subjects during 1960’s and 70’s.