PRINCIPLES OF ICH – GOOD CLINICAL PRACTICE GUIDELINES.pptx
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Slide is about principles of Good Clinical Practice (GCP) according to International Conference On Harmonization. It's one of the topic of Clinical research and pharmacovogilance subject of M pharm Pharmacology second semester. Slide include total 10principles according to ICH guidelines.
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OVERVIEW OF ICH-GCP GUIDELINES
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.ppt
The document discusses ICH-GCP (International Council for Harmonization - Good Clinical Practice) guidelines. ICH-GCP is an international ethical and quality standard for clinical trial design and conduct. It aims to protect trial subjects and ensure data credibility. ICH involves regulators and industry from the US, EU, and Japan. The guidelines include 13 principles for ethical trial conduct in accordance with the Declaration of Helsinki and regulatory requirements. Principles address informed consent, qualifications of investigators, monitoring trial quality systems, and protecting subject confidentiality. ICH-GCP ensures ethical research by providing guidelines that must be followed by institutional review boards, investigators, and sponsors.
Good Clinical Practice By: Swapnil L. patil
Good Clinical Practice (GCP) provides quality standards for clinical research to ensure human subjects are protected and study results are reliable. Key responsibilities include Institutional Review Boards overseeing studies, investigators providing medical care and adhering to protocols, and sponsors manufacturing products and monitoring trials. GCP aims to conduct ethical research through informed consent, qualifications of researchers, and quality management systems.
ICH GCP guidelines
This document reviews Good Clinical Practice (GCP) guidelines. It aims to study GCP principles and their application. The document outlines the objectives, contents, and introduction to GCP. It describes 14 GCP principles regarding ethical conduct of clinical trials, including protocol development, risk identification, benefit-risk assessment, review by ethics committees, informed consent, qualifications of investigators and staff, record keeping, confidentiality, manufacturing standards, and quality systems. The document provides examples of how each principle is applied in clinical research. It concludes with a bibliography on GCP guidelines and resources.
Good clinical practice by vijay
The document discusses the history and purpose of Good Clinical Practice (GCP) guidelines. It aimed to harmonize clinical trial regulations across regions to facilitate acceptance of trial data internationally and remove inefficiencies. GCP provides a quality standard for trial conduct that protects rights and welfare of subjects. It developed guidelines for drugs, biologics and devices approved by regulatory agencies. GCP ensures trials are scientifically sound and ethically conducted according to principles like informed consent, risk-benefit assessment and independent review.
INDIAN GCP GUIDELINE. for Regulatory affair 1st sem CRR
This document provides an overview of the Indian GCP guideline. It discusses key aspects of GCP including principles, the role of the independent ethics committee, informed consent process, responsibilities of sponsors, investigators and monitors, special considerations for vulnerable populations in clinical trials, and comparisons between Indian GCP and ICH GCP.
S1 KAVANA BB MBAT-Goos clinical Pratice.pptx
Good clinical practices (GCP) are international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects. GCP provides protection for trial subjects, enhances the quality and integrity of trial data, and helps ensure that trial results are credible and reported appropriately. The seminar discussed the history and development of GCP, from the Nuremberg Code to the ICH guidelines, with the goal of establishing consistent standards that are acceptable globally.
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The document discusses ethical guidelines for clinical research involving human subjects, particularly for drug and vaccine trials. It outlines the history of ethical guidelines in India, the role of institutional ethics committees in approving research, and 12 basic ethical principles including voluntary informed consent, risk minimization, and public interest. Guidelines for drug trials require approval from regulatory authorities and adherence to phases for testing safety, efficacy, and post-marketing surveillance. Vaccine trial guidelines also involve three phases of testing safety, immunogenicity, and effectiveness in preventing disease.
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OVERVIEW OF ICH-GCP GUIDELINES
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.ppt
The document discusses ICH-GCP (International Council for Harmonization - Good Clinical Practice) guidelines. ICH-GCP is an international ethical and quality standard for clinical trial design and conduct. It aims to protect trial subjects and ensure data credibility. ICH involves regulators and industry from the US, EU, and Japan. The guidelines include 13 principles for ethical trial conduct in accordance with the Declaration of Helsinki and regulatory requirements. Principles address informed consent, qualifications of investigators, monitoring trial quality systems, and protecting subject confidentiality. ICH-GCP ensures ethical research by providing guidelines that must be followed by institutional review boards, investigators, and sponsors.
Good Clinical Practice By: Swapnil L. patil
Good Clinical Practice (GCP) provides quality standards for clinical research to ensure human subjects are protected and study results are reliable. Key responsibilities include Institutional Review Boards overseeing studies, investigators providing medical care and adhering to protocols, and sponsors manufacturing products and monitoring trials. GCP aims to conduct ethical research through informed consent, qualifications of researchers, and quality management systems.
ICH GCP guidelines
This document reviews Good Clinical Practice (GCP) guidelines. It aims to study GCP principles and their application. The document outlines the objectives, contents, and introduction to GCP. It describes 14 GCP principles regarding ethical conduct of clinical trials, including protocol development, risk identification, benefit-risk assessment, review by ethics committees, informed consent, qualifications of investigators and staff, record keeping, confidentiality, manufacturing standards, and quality systems. The document provides examples of how each principle is applied in clinical research. It concludes with a bibliography on GCP guidelines and resources.
Good clinical practice by vijay
The document discusses the history and purpose of Good Clinical Practice (GCP) guidelines. It aimed to harmonize clinical trial regulations across regions to facilitate acceptance of trial data internationally and remove inefficiencies. GCP provides a quality standard for trial conduct that protects rights and welfare of subjects. It developed guidelines for drugs, biologics and devices approved by regulatory agencies. GCP ensures trials are scientifically sound and ethically conducted according to principles like informed consent, risk-benefit assessment and independent review.
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This document provides an overview of the Indian GCP guideline. It discusses key aspects of GCP including principles, the role of the independent ethics committee, informed consent process, responsibilities of sponsors, investigators and monitors, special considerations for vulnerable populations in clinical trials, and comparisons between Indian GCP and ICH GCP.
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The document discusses ethical guidelines for clinical research involving human subjects, particularly for drug and vaccine trials. It outlines the history of ethical guidelines in India, the role of institutional ethics committees in approving research, and 12 basic ethical principles including voluntary informed consent, risk minimization, and public interest. Guidelines for drug trials require approval from regulatory authorities and adherence to phases for testing safety, efficacy, and post-marketing surveillance. Vaccine trial guidelines also involve three phases of testing safety, immunogenicity, and effectiveness in preventing disease.
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Good Clinical Practice (GCP) is an international quality standard that provides protection for human subjects in clinical trials. It outlines ethical and scientific standards for trial design, conduct, and reporting. The key principles of GCP are that clinical trials must be justified based on prior evidence; subject well-being must be prioritized over scientific objectives; and trials require oversight from ethics committees and qualified investigators. GCP aims to ensure clinical trial data are credible and that subjects' rights and safety are protected.
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3) The ICH facilitates harmonization across countries/regions to streamline drug development and avoid duplicative trials through consensus guidelines.
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This document provides an overview of Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH). It discusses key events that led to the development of ethical standards in clinical research. The ICH was formed to harmonize technical requirements for drug approval among regions. It establishes guidelines covering non-clinical studies, clinical safety, efficacy, quality, and multidisciplinary topics. The core purpose of GCP and ICH guidelines is to protect research participants and ensure valid clinical trial conduct and data.
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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.
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Good Clinical Practice (GCP) provides standards for conducting clinical trials to ensure protection of human subjects, credibility of data, and compliance with regulations. GCP defines roles and responsibilities in trials and requires risks to subjects be justified by anticipated benefits. Adherence to GCP principles like informed consent and IRB approval provides public assurance that subject rights and safety are protected in research.
Ethical guidelines for biomedical research in human participants
This document provides ethical guidelines for biomedical research involving human participants. It discusses the history of human research ethics beginning with the Nuremberg Code and Declaration of Helsinki. It establishes the role of institutional ethics committees in reviewing all proposed research and provides general ethical principles of respect for persons, beneficence, and justice. It outlines 12 basic principles and specific ethical principles for informed consent, vulnerable populations, privacy/confidentiality, and more. The document aims to ensure the ethical conduct of research and protection of human subjects.
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Ich e6(r1)
This document provides an overview of ICH E6(R1) guidelines for good clinical practice. The key points are:
1. ICH E6(R1) provides ethical and quality standards for clinical trial design, conduct, recording and reporting to protect subject rights and ensure data credibility.
2. The guidelines aim to harmonize standards across Europe, Japan and the US to facilitate mutual acceptance of clinical data by regulatory authorities.
3. The document outlines principles like prioritizing subject safety, obtaining informed consent, and ensuring trial conduct follows approved protocols.
4. It also describes responsibilities of parties involved like investigators, sponsors, and ethics committees. Proper documentation and oversight are important to demonstrate
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Institutional ethics committee & informed consent
The document discusses various topics related to medical ethics and research involving human subjects, including:
1. Historical events that shaped ethical guidelines like the Nuremberg Code and Declaration of Helsinki.
2. The structure and functions of Institutional Ethics Committees, including their role in reviewing research proposals and providing oversight.
3. Key principles of ethical research like informed consent, minimizing risks, and protecting participant privacy and welfare.
4. Issues around informed consent processes and the review of research by ethics committees.
GCP-Good Clinical Practice
The Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clinical trials with human participants
Institutional review board/Independent ethics Committee
The document discusses the role and functions of an Institutional Review Board (IRB) or Independent Ethics Committee (IEC). The IRB protects the rights and welfare of human subjects in research. It reviews research proposals to ensure they are ethical and in compliance with regulations. The IRB upholds principles like respect for persons, beneficence, and justice. It is composed of members from varying backgrounds who review research proposals and can approve, require modifications to, or disapprove research.
ICH-GCP Guidelines
The document provides an overview of ICH-GCP (Good Clinical Practice) guidelines, which are international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects. The summary discusses the key sections and principles of ICH-GCP, which aim to protect trial subjects and ensure valid clinical trial data. It outlines the historical background and development of GCP standards from the Nuremberg Code to the ICH-GCP guidelines of 1996. The document reviews responsibilities of ethics committees, sponsors, investigators, clinical trial protocols, and informed consent processes.
ICH GCP GUIDELINES FOR CONDUCT OF TRIAL
The document discusses the ICH GCP guidelines for conducting clinical trials. The key points are:
1) GCP guidelines provide ethical and quality standards for clinical trial conduct to protect subject safety and ensure data credibility.
2) The guidelines establish responsibilities for investigators, sponsors, and ethics committees to follow principles where subject welfare prevails over science and trials must be scientifically sound.
3) The ICH facilitates harmonization across countries/regions to streamline drug development and avoid duplicative trials through consensus guidelines.
Gcp
The document discusses Good Clinical Practices (GCP), which are international ethical and scientific quality standards for clinical research involving human subjects. It outlines the goals and foundations of GCP, including protecting subjects' rights and safety, ensuring quality data collection, and providing guidelines for clinical research conduct. The key principles discussed are from the Nuremberg Code, Declaration of Helsinki, Belmont Report, ICH-GCP guidelines, and ISO 14155. Compliance with GCP provides assurance that clinical trials are properly designed, monitored, recorded and reported to protect subject welfare and ensure results credibility.
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Ethical guidelines for biomedical research in human participants
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In this webinar, participants learned how to utilize Generative AI to streamline operations and elevate member engagement. Amazon Web Service experts provided a customer specific use cases and dived into low/no-code tools that are quick and easy to deploy through Amazon Web Service (AWS.)
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- 1. PRINCIPLES OF ICH – GOODCLINICAL PRACTICEGUIDELINES Presented by : Sakshi Nalkande M pharm ( Pharmacology) II Sem Smt. Kishoritai Bhoyar College of Pharmacy, Kamptee Nagpur.
- 2. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
- 3. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
- 4. A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion. The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
- 5. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task. Freely given informed consent should be obtained from every subject prior to clinical trial participation. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
- 6. Thank You!