This document provides an overview of Good Clinical Practice (GCP) guidelines, including:
- The historical background and development of GCP from codes like the Nuremberg Code to modern guidelines.
- The key principles of GCP including ethics, informed consent, responsibilities of sponsors, investigators, and monitors.
- Requirements for ethics committees and special considerations for trials involving vulnerable groups.
- Guidelines address the design, conduct, monitoring, recording, analysis and reporting of clinical trials involving human subjects.
This document discusses the process of informed consent for clinical research studies. It defines informed consent as a voluntary confirmation by a research subject of their willingness to participate after being informed of all relevant study details. The goal is to provide sufficient information for subjects to make an informed choice about participation. Key aspects of the informed consent process include guidelines from regulatory bodies, ensuring subjects' comprehension and voluntariness, obtaining consent at the right time and place, addressing any questions, and documenting consent with a signed form. The form should include essential elements like the study purpose, risks, benefits, and subjects' rights, as well as additional details like withdrawal criteria and contact information.
This document provides an introduction to pharmacoepidemiology. It defines pharmacoepidemiology as the study of drug use and effects in large populations. It discusses study designs used in pharmacoepidemiology including randomized trials, cohort studies, case-control studies, and case reports. Reasons for performing pharmacoepidemiology studies include fulfilling regulatory and legal obligations, assessing drug safety, and generating or testing hypotheses. Sources of data include spontaneous adverse event reporting, prescription databases, and electronic health records. The document also briefly discusses molecular pharmacoepidemiology, bioethics, pharmacoeconomics, and measuring quality of life outcomes.
The IRB/IEC is an independent body that reviews clinical trial protocols and protects participant rights and well-being. It consists of at least five qualified members from diverse backgrounds. The IRB/IEC reviews trials annually, ensures informed consent, and maintains documentation for regulatory review.
This document provides an overview of Good Clinical Practice (GCP) guidelines, including:
- The historical background and development of GCP from codes like the Nuremberg Code to modern guidelines.
- The key principles of GCP including ethics, informed consent, responsibilities of sponsors, investigators, and monitors.
- Requirements for ethics committees and special considerations for trials involving vulnerable groups.
- Guidelines address the design, conduct, monitoring, recording, analysis and reporting of clinical trials involving human subjects.
This document discusses the process of informed consent for clinical research studies. It defines informed consent as a voluntary confirmation by a research subject of their willingness to participate after being informed of all relevant study details. The goal is to provide sufficient information for subjects to make an informed choice about participation. Key aspects of the informed consent process include guidelines from regulatory bodies, ensuring subjects' comprehension and voluntariness, obtaining consent at the right time and place, addressing any questions, and documenting consent with a signed form. The form should include essential elements like the study purpose, risks, benefits, and subjects' rights, as well as additional details like withdrawal criteria and contact information.
This document provides an introduction to pharmacoepidemiology. It defines pharmacoepidemiology as the study of drug use and effects in large populations. It discusses study designs used in pharmacoepidemiology including randomized trials, cohort studies, case-control studies, and case reports. Reasons for performing pharmacoepidemiology studies include fulfilling regulatory and legal obligations, assessing drug safety, and generating or testing hypotheses. Sources of data include spontaneous adverse event reporting, prescription databases, and electronic health records. The document also briefly discusses molecular pharmacoepidemiology, bioethics, pharmacoeconomics, and measuring quality of life outcomes.
The IRB/IEC is an independent body that reviews clinical trial protocols and protects participant rights and well-being. It consists of at least five qualified members from diverse backgrounds. The IRB/IEC reviews trials annually, ensures informed consent, and maintains documentation for regulatory review.
The document outlines the regulatory requirements and guidelines in India for permission to import, manufacture, and conduct clinical trials of new drugs. It discusses the relevant sections of Schedule Y and the Drugs and Cosmetics Rules, 1945. Key points include the application process for import/manufacture using Form 44, responsibilities of sponsors and investigators, ethics committee oversight, and guidelines for the different phases of clinical trials from Phase I to Phase IV. It also addresses requirements for special populations like pediatrics, geriatrics, and pregnant/nursing women. Post-marketing surveillance and periodic safety update reporting are mandated.
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
Clinical trial protocol, ammendments, Protocol deviations and violationsAmol Patil
This document provides guidelines for developing a clinical trial protocol including general information, background, aims and objectives, inclusion/exclusion criteria, study design, methodology, statistics, ethics, quality control, and protocol amendments. Key elements that must be addressed in the protocol are enumerated such as the research question, treatment characteristics, data collection and analysis, and legal responsibilities. Protocol deviations and violations that occur during the study are also discussed along with examples and regulatory requirements for reporting them. Adherence to good clinical practice and obtaining necessary approvals are emphasized.
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.
This document discusses clinical trials and their various components. It begins with an introduction to clinical trials, their purpose and importance. It then describes the key elements of a clinical trial protocol including the trial design, eligibility criteria, safety measures, statistical analysis plan and informed consent process. It also discusses the role and composition of the Institutional Review Board/Independent Ethics Committee which reviews and approves clinical trial protocols and procedures. Finally, it provides an overview of the four phases of clinical trials and concludes with references.
This document discusses microdosing studies, which involve administering very small, sub-therapeutic doses of drug candidates to humans early in clinical trials. The goals are to obtain human pharmacokinetic and metabolic data prior to traditional Phase 1 trials in order to select promising candidates and eliminate unsuccessful ones earlier. Microdosing studies have advantages like accelerating development timelines and reducing costs by focusing resources on candidates more likely to succeed in later trials. The document covers the concept, goals, procedures, uses, advantages, and regulatory guidelines of microdosing studies.
Overview regulatory environment in usa,europe,indiashabana parveen
The document summarizes the process for clinical research and drug approval by the FDA. It describes the multi-step process including pre-clinical research in animals, Phase 1-3 clinical trials in humans to test safety and efficacy, and the submission of a New Drug Application. The FDA rigorously reviews data at each stage before approving progression to the next stage to ensure safety. The overall process aims to establish that new drugs are safe and effective for use by the American public.
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
Dr. Kaushik Mukhopadhyay's presentation discusses the importance of informed consent in clinical research. It provides an overview of the historical events that led to the formalization of informed consent standards, including the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The presentation outlines the key components of informed consent as defined by international and Indian regulatory guidelines, including providing study information, assessing participant comprehension, and ensuring voluntary participation. It emphasizes that informed consent is a process rather than just a signed form and discusses challenges in obtaining proper consent.
This document provides a summary of guidelines for good clinical practice (GCP) according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It discusses the purpose and scope of GCP, which is to ensure proper design, conduct, and reporting of clinical trials involving human subjects. Key topics covered include ethics review, responsibilities of investigators and sponsors, informed consent of subjects, clinical trial documentation and record keeping. The document emphasizes protecting the rights, safety and well-being of clinical trial subjects.
New drugs and clinical trial rules 2019.pdfcrazyboy92
The document summarizes key highlights of the New Drugs and Clinical Trial Rules, 2019 in India. Some of the major changes include defined timelines for approval of clinical trial applications, increased application fees, changes to ethics committee composition and registration validity. It also outlines new definitions, documentation requirements, and provisions for post-trial access and academic clinical trials. The rules supersede the existing Drugs and Cosmetics Rules and aim to encourage new drug development in India while strengthening the clinical trial approval process.
This document outlines the key components and considerations for developing a clinical trial protocol. It discusses that a protocol is a complete written plan for a research study involving human subjects. It identifies important sections such as the title page, objectives, study design, safety reporting, statistical analysis, and informed consent. It emphasizes that the protocol language should be clear, concise, and understandable for diverse readers. It also provides guidance on properly writing eligibility criteria, adverse event definitions, and obtaining informed consent to protect human subjects.
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The document discusses the role and responsibilities of an Institutional Review Board/Independent Ethics Committee (IRB/IEC). It states that an IRB/IEC reviews clinical trial protocols to ensure the ethical treatment of study participants and protection of their rights and well-being. The IRB/IEC is composed of at least five members with diverse qualifications and one member from a non-scientific discipline. It is responsible for approving, monitoring and reviewing research involving humans. The IRB/IEC conducts initial and annual reviews of trial procedures and documentation. All records are maintained for at least three years.
The document discusses case report forms (CRFs), which are used in clinical trials to record patient data. It defines CRFs and explains that they contain all protocol-required information including adverse events. The goals of CRFs are to collect verifiable data according to Good Clinical Practice standards. CRFs can be paper-based or electronic. Well-designed CRFs are structured and formatted consistently to facilitate accurate data collection while avoiding duplication. CRFs provide essential standardized data that is analyzed to advance medical research.
Institutional review board/Research and ethical committeeMerrinJoseph1
Dr. Merrin Joseph,Department of pharmacy practice,Institutional Review board /Research and ethical committee,definition,scope,members,responsibilities,procedures,records,for safeguard the rights of human subject in clinical trial
This document summarizes the regulations and history around generic drug applications (ANDAs) in the United States. It explains that an ANDA is an application to produce a generic version of an approved drug that is the same in dosage, strength, and use. The document outlines the basic requirements for generic drugs and discusses the historical approval pathways including ANDAs, paper NDAs, and monographs that preceded the modern system established by the Hatch-Waxman Act of 1984. This law standardized the ANDA process and established provisions to balance generic competition with patent protections for brand drugs.
Before the enrollment of a patient in a clinical trial and beginning of any trial-related procedures, an informed consent is obtained from the potential participants. This informed consent form (ICF) provides the participants with the information related to the clinical trial. TSDP provides regulatory medical writing training on preparation of ICF.
Phase III clinical trials involve 300 to 3,000 volunteers and last 1 to 4 years. They are designed to further assess a drug's safety, efficacy, and effectiveness. Only about 25-30% of drugs proceed from Phase II to Phase III. Phase III trials provide most of the safety data needed for regulatory approval and marketing. If results are satisfactory, trial findings are compiled into a regulatory submission for review by health authorities. Approximately 50% of drug candidates either fail Phase III trials or are rejected by regulatory agencies.
The document summarizes the key changes to clinical trial regulations in India in 2019. Some of the major changes include shorter approval timelines for clinical trials (45 days from 100 days previously), increased application fees, stricter timelines for reporting serious adverse events, and new pre-submission and post-submission meetings with regulators. The new rules aim to streamline processes, ensure patient safety, and align certain aspects of regulation with international guidelines like ICH. Overall, the changes brought greater clarity and transparency to various aspects of conducting clinical trials in India.
Clinical evaluation is the process of assessing clinical data to verify the safety and performance of a medical device for its intended use. It involves three main stages: 1) identifying existing clinical data from literature and reports, 2) appraising individual data sets for sufficiency, and 3) analyzing the overall strength of evidence and conclusions about safety and performance. If existing data is insufficient, new clinical evaluations must be conducted. A clinical evaluation report is prepared when existing data demonstrates conformity with essential requirements.
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
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.
The document outlines the regulatory requirements and guidelines in India for permission to import, manufacture, and conduct clinical trials of new drugs. It discusses the relevant sections of Schedule Y and the Drugs and Cosmetics Rules, 1945. Key points include the application process for import/manufacture using Form 44, responsibilities of sponsors and investigators, ethics committee oversight, and guidelines for the different phases of clinical trials from Phase I to Phase IV. It also addresses requirements for special populations like pediatrics, geriatrics, and pregnant/nursing women. Post-marketing surveillance and periodic safety update reporting are mandated.
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
Clinical trial protocol, ammendments, Protocol deviations and violationsAmol Patil
This document provides guidelines for developing a clinical trial protocol including general information, background, aims and objectives, inclusion/exclusion criteria, study design, methodology, statistics, ethics, quality control, and protocol amendments. Key elements that must be addressed in the protocol are enumerated such as the research question, treatment characteristics, data collection and analysis, and legal responsibilities. Protocol deviations and violations that occur during the study are also discussed along with examples and regulatory requirements for reporting them. Adherence to good clinical practice and obtaining necessary approvals are emphasized.
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.
This document discusses clinical trials and their various components. It begins with an introduction to clinical trials, their purpose and importance. It then describes the key elements of a clinical trial protocol including the trial design, eligibility criteria, safety measures, statistical analysis plan and informed consent process. It also discusses the role and composition of the Institutional Review Board/Independent Ethics Committee which reviews and approves clinical trial protocols and procedures. Finally, it provides an overview of the four phases of clinical trials and concludes with references.
This document discusses microdosing studies, which involve administering very small, sub-therapeutic doses of drug candidates to humans early in clinical trials. The goals are to obtain human pharmacokinetic and metabolic data prior to traditional Phase 1 trials in order to select promising candidates and eliminate unsuccessful ones earlier. Microdosing studies have advantages like accelerating development timelines and reducing costs by focusing resources on candidates more likely to succeed in later trials. The document covers the concept, goals, procedures, uses, advantages, and regulatory guidelines of microdosing studies.
Overview regulatory environment in usa,europe,indiashabana parveen
The document summarizes the process for clinical research and drug approval by the FDA. It describes the multi-step process including pre-clinical research in animals, Phase 1-3 clinical trials in humans to test safety and efficacy, and the submission of a New Drug Application. The FDA rigorously reviews data at each stage before approving progression to the next stage to ensure safety. The overall process aims to establish that new drugs are safe and effective for use by the American public.
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
Dr. Kaushik Mukhopadhyay's presentation discusses the importance of informed consent in clinical research. It provides an overview of the historical events that led to the formalization of informed consent standards, including the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The presentation outlines the key components of informed consent as defined by international and Indian regulatory guidelines, including providing study information, assessing participant comprehension, and ensuring voluntary participation. It emphasizes that informed consent is a process rather than just a signed form and discusses challenges in obtaining proper consent.
This document provides a summary of guidelines for good clinical practice (GCP) according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It discusses the purpose and scope of GCP, which is to ensure proper design, conduct, and reporting of clinical trials involving human subjects. Key topics covered include ethics review, responsibilities of investigators and sponsors, informed consent of subjects, clinical trial documentation and record keeping. The document emphasizes protecting the rights, safety and well-being of clinical trial subjects.
New drugs and clinical trial rules 2019.pdfcrazyboy92
The document summarizes key highlights of the New Drugs and Clinical Trial Rules, 2019 in India. Some of the major changes include defined timelines for approval of clinical trial applications, increased application fees, changes to ethics committee composition and registration validity. It also outlines new definitions, documentation requirements, and provisions for post-trial access and academic clinical trials. The rules supersede the existing Drugs and Cosmetics Rules and aim to encourage new drug development in India while strengthening the clinical trial approval process.
This document outlines the key components and considerations for developing a clinical trial protocol. It discusses that a protocol is a complete written plan for a research study involving human subjects. It identifies important sections such as the title page, objectives, study design, safety reporting, statistical analysis, and informed consent. It emphasizes that the protocol language should be clear, concise, and understandable for diverse readers. It also provides guidance on properly writing eligibility criteria, adverse event definitions, and obtaining informed consent to protect human subjects.
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The document discusses the role and responsibilities of an Institutional Review Board/Independent Ethics Committee (IRB/IEC). It states that an IRB/IEC reviews clinical trial protocols to ensure the ethical treatment of study participants and protection of their rights and well-being. The IRB/IEC is composed of at least five members with diverse qualifications and one member from a non-scientific discipline. It is responsible for approving, monitoring and reviewing research involving humans. The IRB/IEC conducts initial and annual reviews of trial procedures and documentation. All records are maintained for at least three years.
The document discusses case report forms (CRFs), which are used in clinical trials to record patient data. It defines CRFs and explains that they contain all protocol-required information including adverse events. The goals of CRFs are to collect verifiable data according to Good Clinical Practice standards. CRFs can be paper-based or electronic. Well-designed CRFs are structured and formatted consistently to facilitate accurate data collection while avoiding duplication. CRFs provide essential standardized data that is analyzed to advance medical research.
Institutional review board/Research and ethical committeeMerrinJoseph1
Dr. Merrin Joseph,Department of pharmacy practice,Institutional Review board /Research and ethical committee,definition,scope,members,responsibilities,procedures,records,for safeguard the rights of human subject in clinical trial
This document summarizes the regulations and history around generic drug applications (ANDAs) in the United States. It explains that an ANDA is an application to produce a generic version of an approved drug that is the same in dosage, strength, and use. The document outlines the basic requirements for generic drugs and discusses the historical approval pathways including ANDAs, paper NDAs, and monographs that preceded the modern system established by the Hatch-Waxman Act of 1984. This law standardized the ANDA process and established provisions to balance generic competition with patent protections for brand drugs.
Before the enrollment of a patient in a clinical trial and beginning of any trial-related procedures, an informed consent is obtained from the potential participants. This informed consent form (ICF) provides the participants with the information related to the clinical trial. TSDP provides regulatory medical writing training on preparation of ICF.
Phase III clinical trials involve 300 to 3,000 volunteers and last 1 to 4 years. They are designed to further assess a drug's safety, efficacy, and effectiveness. Only about 25-30% of drugs proceed from Phase II to Phase III. Phase III trials provide most of the safety data needed for regulatory approval and marketing. If results are satisfactory, trial findings are compiled into a regulatory submission for review by health authorities. Approximately 50% of drug candidates either fail Phase III trials or are rejected by regulatory agencies.
The document summarizes the key changes to clinical trial regulations in India in 2019. Some of the major changes include shorter approval timelines for clinical trials (45 days from 100 days previously), increased application fees, stricter timelines for reporting serious adverse events, and new pre-submission and post-submission meetings with regulators. The new rules aim to streamline processes, ensure patient safety, and align certain aspects of regulation with international guidelines like ICH. Overall, the changes brought greater clarity and transparency to various aspects of conducting clinical trials in India.
Clinical evaluation is the process of assessing clinical data to verify the safety and performance of a medical device for its intended use. It involves three main stages: 1) identifying existing clinical data from literature and reports, 2) appraising individual data sets for sufficiency, and 3) analyzing the overall strength of evidence and conclusions about safety and performance. If existing data is insufficient, new clinical evaluations must be conducted. A clinical evaluation report is prepared when existing data demonstrates conformity with essential requirements.
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
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.
This document provides an overview of training on Good Clinical Practice (GCP) and Schedule Y. It begins with the basics of clinical research and phases of clinical trials. It then covers the historical guidelines around medical ethics, including the Declaration of Helsinki and ICH GCP. An introduction to GCP discusses objectives, definitions, and principles. Schedule Y requirements for clinical research in India are also introduced. The roles of the regulatory authority, sponsor, investigator, and institutional ethics committee in clinical trials are outlined.
The document discusses the importance of clinical research for developing new diagnostic methods and treatments through systematic studies on pharmaceutical products in human subjects to evaluate safety, efficacy, and pharmacokinetics. It explains the different types of clinical trials including treatment, prevention, screening, diagnostic, and quality of life trials conducted in four phases to translate basic research findings into improved medical care. The key elements of a clinical trial protocol are also outlined including background information, objectives, methodology, and plans for administration, oversight, and regulation.
The document discusses clinical research and clinical trials, explaining that clinical trials are important for developing new treatments and furthering medical progress. It covers the different types of clinical trials including treatment, prevention, screening, diagnostic, and quality of life trials. The document also outlines the four phases of clinical trials and the purpose and typical size of participants in each phase.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
This document provides an overview of clinical trial teams and their responsibilities. It defines a clinical trial and outlines the approval process. The main stakeholders in a clinical trial are identified as the sponsor, investigators, ethics committee, regulatory authorities, and study subjects. Key responsibilities are described for each stakeholder. The clinical trial process is outlined as initiating a trial, conducting it, closing it, and registering/publishing results. Specific responsibilities are defined for investigators, study coordinators, sponsors, and contract research organizations.
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.
Clinical Trials: Types and Design
Experimental Study- RCT and Non RCT, Observation Study: Cohort, Case Control, Cross sectional
Clinical Trial Study Team Roles and responsibilities of Clinical Trial Personnel: Investigator, Study Coordinator, Sponsor, Contract Research Organization and its management.
Clinical trials involve testing new drugs and treatments on humans to evaluate safety and efficacy. They are conducted in phases, starting with small groups and progressing to larger groups. Prior to conducting clinical trials, approval must be obtained from regulatory authorities like the FDA or DCGI. Trials must abide by ethical guidelines like the Declaration of Helsinki, which require minimizing risks and obtaining informed consent. The document outlines the various phases of clinical trials and legal requirements for conducting trials in India, including obtaining necessary permissions and following guidelines on ethics committee approval and compensation.
Pharmacovigilance safety Mon. in clinical trials.pptxRoshan Yadav
Pharmacovigilance involves monitoring drug safety and adverse effects during clinical trials. Safety monitoring is critical and requires collaboration between stakeholders like sponsors, investigators, ethics committees, and regulators. Common safety monitoring practices include sponsors developing protocols detailing reporting procedures, investigators collecting data in case report forms, and ethics committees and data safety monitoring boards regularly reviewing accumulating trial data to protect participants.
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
What is The Clinical Trial Approval Process In India.pdfPranshuCorpseed
Clinical trials are critical in the development of novel medications and cures, advancing medical science and patient care. The clinical trial ecosystem in India has grown dramatically, making it an appealing destination for pharmaceutical research. This article explores the regulatory framework, ethical concerns, phases of clinical trials, application processes, review, post-approval requirements, obstacles, case studies, and future prospects of clinical trial approval in India.
Preparation of Clinical Trial Protocol of India.Aakashdeep Raval
The document provides information on clinical trial protocols in India. It discusses the purpose of clinical trials and phases of clinical trials from Phase 0 to Phase 4. It explains that the clinical trial protocol is a document that states the background, objectives, design, methodology and statistical considerations of a clinical trial. The protocol describes inclusion/exclusion criteria, assessments of efficacy and safety, data management, quality control and other key elements to ensure proper conduct of the clinical trial. An effective clinical trial protocol provides all the necessary details to guide researchers in safely and ethically evaluating a medical treatment.
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
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
This document outlines the requirements and guidelines for conducting clinical trials and obtaining permission to import or manufacture new drugs in India. It discusses the need to frame guidelines for clinical research and regulation of new drugs. Key points include that clinical trials require permission from the licensing authority and approval from ethics committees. Sponsors must submit various data on the drug and trials must be conducted according to Good Clinical Practice guidelines. Informed consent is required from all subjects and safety of subjects must be protected at all stages of the drug development and approval process. Trials generally proceed through Phases I-III to evaluate safety, efficacy, and optimal dosing.
The document discusses the Bioresearch Monitoring (BIMO) program of the FDA, which aims to protect human subjects, ensure data quality and integrity, and audit clinical research and data. The BIMO program oversees clinical investigators, sponsors, IRBs, and ensures compliance with regulations through inspections and classifications (NAI, VAI, OAI). It also monitors contract research organizations, non-clinical laboratories, and applies regulations on informed consent, financial disclosure, and good clinical practices. The overall goal of the BIMO program is to provide oversight of clinical research and data submitted to the FDA to support new product approvals.
Clinical research teams have several important roles that work together to conduct clinical trials. The key roles include:
- The principal investigator oversees the entire clinical trial and is responsible for all study-related activities.
- Study coordinators manage the day-to-day operations of trials and ensure protocol compliance.
- Sponsors provide financial support and take overall responsibility for the trial.
- Clinical monitors directly evaluate clinical sites to ensure proper conduct and reporting.
- Contract research organizations provide additional operational and administrative support to help run trials. Together, these roles aim to safely and effectively evaluate new medical treatments.
How to Make a Field Mandatory in Odoo 17Celine George
In Odoo, making a field required can be done through both Python code and XML views. When you set the required attribute to True in Python code, it makes the field required across all views where it's used. Conversely, when you set the required attribute in XML views, it makes the field required only in the context of that particular view.
Chapter wise All Notes of First year Basic Civil Engineering.pptxDenish Jangid
Chapter wise All Notes of First year Basic Civil Engineering
Syllabus
Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
Linear Measurements: Instruments used. Linear Measurement by Tape, Ranging out Survey Lines and overcoming Obstructions; Measurements on sloping ground; Tape corrections, conventional symbols. Angular Measurements: Instruments used; Introduction to Compass Surveying, Bearings and Longitude & Latitude of a Line, Introduction to total station.
Levelling: Instrument used Object of levelling, Methods of levelling in brief, and Contour maps.
Chapter 4
Buildings: Selection of site for Buildings, Layout of Building Plan, Types of buildings, Plinth area, carpet area, floor space index, Introduction to building byelaws, concept of sun light & ventilation. Components of Buildings & their functions, Basic concept of R.C.C., Introduction to types of foundation
Chapter 5
Transportation: Introduction to Transportation Engineering; Traffic and Road Safety: Types and Characteristics of Various Modes of Transportation; Various Road Traffic Signs, Causes of Accidents and Road Safety Measures.
Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
Text Books:
1. Palancharmy, Basic Civil Engineering, McGraw Hill publishers.
2. Satheesh Gopi, Basic Civil Engineering, Pearson Publishers.
3. Ketki Rangwala Dalal, Essentials of Civil Engineering, Charotar Publishing House.
4. BCP, Surveying volume 1
Temple of Asclepius in Thrace. Excavation resultsKrassimira Luka
The temple and the sanctuary around were dedicated to Asklepios Zmidrenus. This name has been known since 1875 when an inscription dedicated to him was discovered in Rome. The inscription is dated in 227 AD and was left by soldiers originating from the city of Philippopolis (modern Plovdiv).
Communicating effectively and consistently with students can help them feel at ease during their learning experience and provide the instructor with a communication trail to track the course's progress. This workshop will take you through constructing an engaging course container to facilitate effective communication.
How to Setup Warehouse & Location in Odoo 17 InventoryCeline George
In this slide, we'll explore how to set up warehouses and locations in Odoo 17 Inventory. This will help us manage our stock effectively, track inventory levels, and streamline warehouse operations.
it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
2. INTRODUCTION
Any investigation in human subjects intended to
discover or verify the clinical, pharmacological
and/or other pharmacodynamic effects of an
investigational product(s), and/or to identify any
adverse reactions to an investigational product(s),
and/or to study absorption, distribution, metabolism,
and excretion of an investigational product(s) with
the object of ascertaining its safety and/or efficacy.
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3. Clinical trials are conducted only when
satisfactory information has been gathered on the
quality of the new drug
health authority/ethics committee approval is
granted in the country
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4. STEPS BEFORE CLINICAL TRIAL
Need or Demand
Concept or Idea
Research and Study
Pre Clinical Trial
Satisfactory Result
Ethical clearance
Informed Consent
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5. PHASES OF CLINICAL TRIAL
Phase 0 (Micro Dosing)
For cost cutting
Subject :- 10 to 15
Days :- 7 days
Purpose :- pharmacokinetic and pharmacodynamic
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6. Phase 1 (safety phase)
Subject :- 20 to 80
Purpose :- Safety, tolerability and potentially
damage effect
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7. Phase 2 (Therapeutic exploration)
Subject :- 100 to 500
Purpose :- Efficacy and dose range
NOTE :- first phase where the drug is given to the
diseased patient.
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8. Phase 3 (Therapeutic conformation)
Subject :- 500 to 3000
Purpose :- safety and tolerability
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9. Phase 4 (Post marketing phase )
Conducted after the drug is consumed by the
patients
Purpose :- safety, acceptability, ADR and off label
use.
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11. ETHICS OF CLINICAL TRIAL
According to the ICH-GCP guidelines,all clinical trials should
be conducted in compliance with ethical standards, clear
scientific proof, and benefit overweigh risk; and a clear well-
documented protocol is required.
Obtaining an informed consent and affirming confidentiality.
The trial staff should receive adequate training along with their
appropriate qualifications.
Data should be documented accurately and easily accessible
and available.
Manufacturing the investigational products should be in
accordance with Good Manufacturing Practice (GMP)
guidelines.
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12. ICH-GCP GUIDELINES
Was issued by the International Conference for
Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) in
1996
Representatives of regulatory bodies and pharmaceutical
companies from Japan, United States, European Union,
Australia, Canada, and Nordic Countries as well World
Health Organization (WHO) participated in the
development of these guidelines.
In January1997, the guideline became effective and
implemented for clinical trials involving human subjects
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14. THE PRINCIPLES OF ICH GCP
Clinical trials should be conducted in accordance with the ethical
principles.
Before a trial is initiated, foreseeable risks and inconveniences
should be weighed against the anticipated benefit for the
individual trial subject and society.
The rights, safety, and well-being of the trial subjects are the
most important considerations
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.
Each individual involved in conducting a trial should be
qualified by education, training, and experience to perform his or
her respective task(s).
All clinical trial information should be recorded, handled, and
stored in a way that allows its accurate reporting, interpretation
and verification.
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15. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE
(IRB/IEC)
An independent body (a review board or a committee,
institutional, regional, national, or supranational),
constituted of medical professionals and non-medical
members, whose responsibility it is to ensure the protection
of the rights, safety and well-being of human subjects
involved in a trial and to provide public assurance of that
protection, by, among other things, reviewing and
approving/providing favourable opinion on, the trial
protocol, the suitability of the investigator(s), facilities, and
the methods and material to be used in obtaining and
documenting informed consent of the trial subjects
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16. INVESTIGATOR
A person responsible for the conduct of the clinical trial
at a trial site.
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.
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17. SPONSOR
An individual, company, institution, or organization
which takes responsibility for the initiation,
management, and/or financing of a clinical trial.
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18. PROTOCOL
A document that describes the objective(s), design,
methodology, statistical considerations, and organization
of a trial.
The protocol usually also gives the background and
rationale for the trial.
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19. INVESTIGATOR'S BROCHURE
A compilation of the clinical and nonclinical data on the
investigational product(s) which is relevant to the study of
the investigational product(s) in human subjects.
Contents of the Investigator’s Brochure
• Table of Contents
• Summary
• Introduction
• Physical, Chemical, and Pharmaceutical Properties and Formulation
• Nonclinical Studies
• Effects in Humans
• Summary of Data and Guidance for the Investigator
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20. DOCUMENTATION
All records, in any form (including, but not limited to,
written, electronic, magnetic, and optical records, and
scans, x-rays, and electrocardiograms) that describe or
record the methods, conduct, and/or results of a trial, the
factors affecting a trial, and the actions taken.
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21. ROLE OF PHARMACISTS
Once the pharmacologist has demonstrated a new compound to be
effective and safe in animal test, clinical trials are invariably
commenced.
These trials usually proceed in two steps-preliminary and extended.
During the preliminary stage, the principal investigator cautiously
administers the drug to a limited number of selected patients and closely
follows the results.
After having gained experience and confidence in its use, the
investigator is generally ready to conduct an extended comprehensive
evaluation of its efficacy.
During this stage, the pharmacist can play an important role by assisting
in the development of the protocol and the control of a double blind
test/study—having the experimental drug and placebo prepared exactly
the same dosage form and presentation. Neither the patient nor the
doctor informed as to whether the placebo and the potent article.
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22. CONT…
To safeguard subjects, pharmacist can ensuring that investigated
drugs are appropriate for use and are procured, handled, stored and
used safely and correctly
To ensure that investigated drugs are managed and dispensed to
patients in accordance with the protocol
To ensure that all pharmacy clinical trial procedures comply with
relevant guidelines and regulations
To ensure that the ID is in good condition for use, verify the drug
product packaging and labeling, pharmaceutical form, lot number,
manufacturing and expiration dates, the correct use, handling and
storing conditions
To ensure that the ID is stored according to the room conditions
(temperature, light and humidity)
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