This document outlines the principles of ICH GCP and the role of institutional review boards (IRBs) and independent ethics committees (IECs) in clinical trials. It discusses that clinical trials should be scientifically sound and protect subject safety, rights, and well-being. IRBs/IECs are responsible for reviewing trials and documents like protocols, consent forms and investigator qualifications to ensure these principles are followed. They must provide approval or disapproval of trials in writing and conduct continuing oversight, while maintaining independence from trial sponsors and investigators. The composition, functions, operations and review procedures of IRBs/IECs are also described.
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.
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
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
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.
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
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
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.
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.
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.
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.
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.
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.
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
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.
An overview of Institutional Review Board or Independent Ethics CommitteeClinosolIndia
An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) plays a crucial role in ensuring the ethical conduct of research involving human subjects. These boards are typically established by organizations, institutions, or agencies that conduct or sponsor research activities. The primary purpose of an IRB/IEC is to protect the rights, well-being, and confidentiality of human research participants.
Role of IRB and IEC in Safeguarding the Subjects in Clinical TrialsClinosolIndia
In clinical research, the protection of human subjects is of utmost importance to ensure ethical conduct and adherence to regulatory standards. Two key entities responsible for safeguarding the rights, safety, and well-being of subjects in clinical trials are Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). They play essential roles in the oversight and ethical review of clinical research protocols. Here's a breakdown of their roles in safeguarding clinical trial subjects:
Institutional Review Boards (IRBs):
Ethical Review: IRBs are responsible for conducting an ethical review of research protocols to ensure that the study is designed and conducted in an ethical and morally sound manner. They assess the study's potential risks, benefits, and the protection of subjects' rights.
Informed Consent: IRBs review and approve the informed consent process to ensure that subjects are provided with comprehensive and understandable information about the study, including its purpose, procedures, risks, and benefits. They assess the adequacy of the informed consent document.
Risk-Benefit Assessment: IRBs assess the risks and potential benefits of the research to determine whether they are balanced and reasonable. They weigh the scientific and societal value of the research against the risks posed to subjects.
Subject Recruitment and Selection: IRBs review the methods and materials used for subject recruitment and selection to ensure that they are non-coercive, fair, and do not discriminate against vulnerable populations.
Continual Oversight: IRBs provide ongoing oversight of approved studies. They monitor the progress of research, ensuring that it adheres to the approved protocol and that any deviations or adverse events are appropriately reported and addressed.
Conflict of Interest: IRBs evaluate potential conflicts of interest among researchers, ensuring that financial or non-financial interests do not compromise the rights or safety of research subjects.
Privacy and Confidentiality: IRBs assess how subjects' privacy and confidentiality will be protected, particularly in studies involving sensitive information or data.
Emergency Use of Investigational Products: In cases of emergency use of investigational products, IRBs may provide authorization, ensuring that the use is in the best interest of the subject.
This presentation focuses on Institutional Review Board/ Institutional Ethics Committee, Informed Consent Form and Protocol for a Research. The responsibilities of various personals have also been covered.
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 vitro antidiabetic activity like
Inhibition of Polysaccharide-Degrading Enzymes
Assay for α-Amylase
Assay for α-Glucosidase
Everted Sac Technique for Assaying α-Glucosidase
Assays forGLUT2TransportActivity
Perfusion of Jejunal Loops
Transport Activity of Brush Border Membrane Vesicles
Apical Expression of GLUT2
Evaluation of Glucose Absorption InVivo
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
2. Principles of ICH GCP
• 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(s).
• 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.
3. Continued…
• 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
• 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.
4. Continued…
• All clinical trial information should be recorded, handled, and stored in
a way that allows its accurate reporting, interpretation and verification.
• The confidentiality of records that could identify subjects should be
protected, respecting the privacy and confidentiality rules in
accordance with the applicable regulatory requirement(s).
• Investigational products should be manufactured, handled, and stored
in accordance with applicable good manufacturing practice (GMP).
They should be used in accordance with the approved protocol.
5. IRB / IEC
• Responsibility:
– An IRB/IEC should safeguard the rights, safety, and well-being of all
trial subjects. Special attention should be paid to trials that may
include vulnerable subjects.
– The IRB/IEC should obtain the following documents:
• Trial protocol(s)/amendment(s), written informed consent
form(s) and consent form updates that the investigator
proposes for use in the trial, subject recruitment procedures
(e.g. advertisements), written information to be provided to
subjects.
• Investigator's Brochure (IB), available safety information,
information about payments and compensation available to
subjects, the investigator's current curriculum vitae and/or
other documentation evidencing qualifications, and any other
documents that the IRB/IEC may need to fulfill its
responsibilities
6. Continued…
• The IRB/IEC should review a proposed clinical trial within a
reasonable time and document its views in writing, clearly identifying
the trial, the documents reviewed and the dates for the following:
• approval/ favorable opinion;
• modifications required prior to its approval/ favorable opinion;
• disapproval / negative opinion; and
• termination/suspension of any prior approval/favorable opinion.
• The IRB/IEC should consider the qualifications of the investigator for
the proposed trial, as documented by a current curriculum vitae
and/or by any other relevant documentation the IRB/IEC requests.
7. Continued…
• The IRB/IEC should conduct continuing review of each ongoing trial at
intervals appropriate to the degree of risk to human subjects, but at
least once per year.
• Where the protocol indicates that prior consent of the trial subject or
the subjects legally acceptable representative is not possible, the
IRB/IEC should determine that the proposed protocol and/or other
document(s) adequately addresses relevant ethical concerns and
meets applicable regulatory requirements for such trials (i.e. in
emergency situations).
8. Continued…
• The IRB/IEC should review both the amount and method of payment to
subjects to assure that neither presents problems of coercion or undue
influence on the trial subjects payments to a subject should be
prorated and not wholly contingent on completion of the trial by the
subject.
• The IRB/IEC should ensure that information regarding payment to
subjects, including the methods, amounts, and schedule of payment to
trial subjects, is set forth in the written informed consent form and any
other written information to be provided to subjects. The way payment
will be prorated should be specified.
9. Composition, Functions and Operations of
Ethics committee
• The IRB/IEC should consist of a reasonable number of members, who
collectively have the qualifications and experience to review and
evaluate the science, medical aspects, and ethics of the proposed trial.
It is recommended that the IRB/IEC should include:
a) At least five members.
b) At least one member whose primary area of interest is in a
nonscientific area.
c) At least one member who is independent of the institution/trial site.
Only those IRB/IEC members who are independent of the investigator
and the sponsor of the trial should vote/provide opinion on a trial-
related matter.
A list of IRB/IEC members and their qualifications should be
maintained.
10. Continued…
• Only members who participate in the IRB/IEC review and discussion
should vote/provide their opinion and/or advise.
• The IRB/IEC should perform its functions according to written
operating procedures, should maintain written records of its activities
and minutes of its meetings, and should comply with GCP and with the
applicable regulatory requirement(s).
• The investigator may provide information on any aspect of the trial, but
should not participate in the deliberations of the IRB/IEC or in the
vote/opinion of the IRB/IEC.
11. Procedure of IRB / IEC
• The IRB/IEC should establish, document in writing which should
include:
– Determining its composition (names and qualifications of the
members)
– Providing, according to the applicable regulatory requirements,
expedited review and approval/favourable opinion of minor
change(s) in ongoing trials that have the approval/favourable
opinion of the IRB/IEC.
– Specifying that no subject should be admitted to a trial before the
IRB/IEC issues its written approval/favourable opinion of the trial.
12. Continued
• Specifying that no deviations from, or changes of, the protocol should
be initiated without prior written IRB/IEC approval/favourable
opinion of an appropriate amendment, except when necessary to
eliminate immediate hazards to the subjects or when the change(s)
involves only logistical or administrative aspects of the trial
• Specifying that the investigator should promptly report to the IRB/IEC:
– a) Deviations from, or changes of, the protocol to eliminate
immediate hazards to the trial subjects
– b) Changes increasing the risk to subjects and/or affecting
significantly the conduct of the trial
– c) All adverse drug reactions (ADRs) that are both serious and
unexpected.
– d) New information that may affect adversely the safety of the
subjects or the conduct of the trial.
13. Continued
• Ensuring that the IRB/IEC promptly notify in writing the
investigator/institution concerning:
– a) Its trial-related decisions/opinions.
– b) The reasons for its decisions/opinions.
– c) Procedures for appeal of its decisions/opinions.
• The IRB/IEC should retain all relevant records (e.g., written
procedures, membership lists, lists of occupations/affiliations of
members, submitted documents, minutes of meetings, and
correspondence) for a period of at least 3 years after completion of the
trial and make them available upon request from the regulatory
authority(ies).