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
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.
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
Drug development - Background informationXplore Health
This guide provides background information on the drug development process including the different phases and the ethical, legal and social aspects associated.
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
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.
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
Drug development - Background informationXplore Health
This guide provides background information on the drug development process including the different phases and the ethical, legal and social aspects associated.
2a. The Institutional Review Boards (IRB) are entrusted to protect t.pdfnipuns1983
2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of
participants undergoing clinical research studies. The regulations formulated for reviewing,
approving and conductiong research on humans generally refer to such independant boards like
IRB. IRB has been recognised as one component of Human Research Protection Program
(HRPP) of the Asssociation for the Accreditation of Human Research Protection Program
(AAHRPP) formed in 2001.
The IRB shoulkd have atleast FIVE members from diverse scientific and non-scientific
backgrounds; professional domains, and cultural interests including gender, race and attitude
toward community issues. Atleast one memebr should be from scientific area (having primary
concern in scientific area such as physician, Ph D level physical or biological scientists) and
atleast one from non-scientific area (FDA regulation: 21 CFR 56.107 (C)). Also atleast one
member should not be affiliated with the institution directly or be a community member.
Primary source of information: Jacobs M R (2014) Institutional Review Boards and Independant
Ethics Committees, White paper. Technical report.
b. Most IRB\'s consist of more than five members to encompass additional expertise while
convening the meetings. As per the regulations of International Conference on Harmonisation
(ICH), department of Health and Human sciences (DHHS) and the Food and Drug
Administration (FAD), the memebers of IRB should have adequate expertise in assessing the
quality of science, medical aspects of proposed research and the ethics of conducting
studies.This implies the need to have atleast one member as physician. IRB can also approve an
alternate member in the absence of the primary member. Even outside consultants can be invited
to have opinion on scientific and ethical issues beyond the expertise of the convened committee,
however, they do not have the right to vote for approving the research.
When the research involve vulnerable populations such as children, prisoners, pregnant women,
handicapped and mentally impaired, the individuals having expertise and understanding on the
issue should be included. So also, the participants or subjects in the research study who can
become potential vulnerable groups should also be considered.
c. The IRB reviews the clinical trial protocols and ensure that the participants have minimal risks
in relation to the benefits from the research. Such reviews are done before and during the trials.
The IRB perform periodic reviews or continuing reviews through out the entire duration of the
trial. Such reviews happen atleast once a year and cover the entire trials and not just changes.
The IRB also seek additional information about the payments and compenations to study
participants and informed consent process.
Solution
2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of
participants undergoing clinical research studies. The regulations formulated for.
CDSCO Biologicals - Rules, Regulations, Guidelines and Standards for Regulato...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Regulations and Legislation for Biologics (MRA 104T)
Unit 2 - Rules, Regulations, Guidelines and Standards for Regulatory Filing of Biologicals
CDSCO Biologicals
Regulatory requirements for drug approval - industrial pharmacy IIJafarali Masi
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
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.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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2a. The Institutional Review Boards (IRB) are entrusted to protect t.pdfnipuns1983
2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of
participants undergoing clinical research studies. The regulations formulated for reviewing,
approving and conductiong research on humans generally refer to such independant boards like
IRB. IRB has been recognised as one component of Human Research Protection Program
(HRPP) of the Asssociation for the Accreditation of Human Research Protection Program
(AAHRPP) formed in 2001.
The IRB shoulkd have atleast FIVE members from diverse scientific and non-scientific
backgrounds; professional domains, and cultural interests including gender, race and attitude
toward community issues. Atleast one memebr should be from scientific area (having primary
concern in scientific area such as physician, Ph D level physical or biological scientists) and
atleast one from non-scientific area (FDA regulation: 21 CFR 56.107 (C)). Also atleast one
member should not be affiliated with the institution directly or be a community member.
Primary source of information: Jacobs M R (2014) Institutional Review Boards and Independant
Ethics Committees, White paper. Technical report.
b. Most IRB\'s consist of more than five members to encompass additional expertise while
convening the meetings. As per the regulations of International Conference on Harmonisation
(ICH), department of Health and Human sciences (DHHS) and the Food and Drug
Administration (FAD), the memebers of IRB should have adequate expertise in assessing the
quality of science, medical aspects of proposed research and the ethics of conducting
studies.This implies the need to have atleast one member as physician. IRB can also approve an
alternate member in the absence of the primary member. Even outside consultants can be invited
to have opinion on scientific and ethical issues beyond the expertise of the convened committee,
however, they do not have the right to vote for approving the research.
When the research involve vulnerable populations such as children, prisoners, pregnant women,
handicapped and mentally impaired, the individuals having expertise and understanding on the
issue should be included. So also, the participants or subjects in the research study who can
become potential vulnerable groups should also be considered.
c. The IRB reviews the clinical trial protocols and ensure that the participants have minimal risks
in relation to the benefits from the research. Such reviews are done before and during the trials.
The IRB perform periodic reviews or continuing reviews through out the entire duration of the
trial. Such reviews happen atleast once a year and cover the entire trials and not just changes.
The IRB also seek additional information about the payments and compenations to study
participants and informed consent process.
Solution
2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of
participants undergoing clinical research studies. The regulations formulated for.
CDSCO Biologicals - Rules, Regulations, Guidelines and Standards for Regulato...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Regulations and Legislation for Biologics (MRA 104T)
Unit 2 - Rules, Regulations, Guidelines and Standards for Regulatory Filing of Biologicals
CDSCO Biologicals
Regulatory requirements for drug approval - industrial pharmacy IIJafarali Masi
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
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.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
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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
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Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
2. Bio-equivalence
Bioequivalence is the property of two dosage forms or active
ingredients with similar blood concentration levels that produce the
same effect at the site of physiologic activity.
3. Bio-Equivalence Studies
Bio-equivalence studies are done for:
Comparison the bioavailability of generic drug products to the
brand name product.
To check that the bioequivalent drugs have same systemic
bioavailability will have same predictable drug response.
To monitor the pharmacokinetic and pharmacodynamic parameters
after the administration of tested drugs.
For intervention study to examine effects e.g Food and concomitant
medication.
4. Types of Bio-equivalence Studies
In vivo
1. Oral immediate release product with systemic action.
2. Non-Oral immediate release product.
3. Modified release product with systemic action.
In vitro
1. The drug product can be differ only in strength, must follow the
conditions like:
a) Same ratio between active compounds and excipients.
b) Same qualitative composition.
c) Pharmacokinetics linear.
5. 1. Should meet all the requirements like:
a) Solution or solubilized form.
b) Topical administration.
c) Oral administration.
d) By inhalation as a gas or vapor.
6. Assessment of Bio-equivalence
BE studies are generally recommended by using the following
endpoints:
Pharmacokinetic studies
Pharmacodynamic studies
Comparative Clinical studies
In vitro dissolution studies
7. Pharmacokinetics method to assess BE
The two major pharmacokinetic methods used to assess BE are:
1. Plasma level-time studies
2. Urinary excretion studies
8. Design of Bio-Equivalence Studies
The basic design is determined by:
The nature of reference material and dose form to be tested.
The availability of analytical method.
Scientific questions to be answered.
Benefit-risk and ethical consideration with regard to testing in
humans. For some drugs, FDA offers general guidelines for
conducting these studies.
9. ETHICS
Ethics are a personal code of conduct based on respect for one's
self, others and surroundings and is governed by the principles or
assumptions underpinning the way individuals or organizations
ought to conduct themselves.
Research ethics involves the application of fundamental ethical
principles to research activities which include the design and
implementation of research, respect towards society and others,
the use of resources and research outputs, scientific misconduct
and the regulation of research.
10. Ethical Consideration
Guidelines are specifically developed to guide researchers to conduct
bioequivalence studies by following international and national forums;
1. Declaration of Helsinki 1964 (Revised on 1975, 1983, 1989, 1996,
2000, and 2008)
2. World Health Organization (WHO; Technical Report Series # 996,
2016)
3. Drug Regulatory of Pakistan (DRAP; Guideline For Industry On
Investigation Of Bio-equivalence (BE) / Bioavailability (BA)
Studies For Multisource Generic Drug Products, 1st Edition, 2021)
4. Institutional Review Boards (IRB)/ Independent Ethics Committee
(IEC)
11. DRAP Statement regarding BA/BE
All research involving human subjects should be conducted in
accordance with the ethical principles contained in the current
version of the Declaration of Helsinki, including respect for persons,
beneficence (“maximize benefits and minimize harms and wrongs”)
and non-maleficence (“do no harm”), as defined by the International
Ethical Guidelines for Biomedical Research Involving Human
Subjects issued by the Council for International Organizations of
Medical Sciences (CIOMS), including rules/ regulations issued by
DRAP.
12. Basic Ethical Principles:
Respect for persons
Beneficence
Justice
Essential Parameters:
Informed Consent
Assessment of risks and benefits
Selection of subjects
13. Subject Selection
Subjects could be both male/female, however the risks should be
considered.
Subjects should be between 18-55 years old , capable of giving
informed consent and of weight within the normal range or Body
Mass Index (BMI) of 18-30.
They should be screened by clinical laboratory testing , medical
history and a comprehensive medical examination.
Subjects should be non-smoker and without a history of drug abuse
and alcohol.
14. Inclusion/Withdrawl of Volunteers
If the investigational active substance have adverse effects/risks
then it will be unacceptable for healthy volunteers, its necessary to
use patients under precautions and supervision.
Alternatives should be given.
15. Informed Consent
Process of providing research participants with information enables
them to make an informed decision whether they want to participate
in studies.
State the purpose and procedure of these studies
Potential risks/discomforts the participants may encounter.
Extents to which results will be confidential.
Potential benefits from participation.
List of names of other participants for their comfort.
Participants are free to withdraw from the study at any time.
Consents must be obtained from parents/guardians and must also
obtained from minors, old enough/have enough capacity to show
willingness for participation
16. Deception
Providing false information to the participants about the nature or
purpose of studies.
Although its discouraged by the AREA but not disallowed in all cases.
Sometimes deception is required in order to conduct a valid
research study. The researcher must justify the use of deception.
17. Protection From Mental and Physical
Harm
It’s the most fundamental ethical issue, must be followed by the
researchers
These studies generally poses minimal risk to participants although
state of stress, anxiety, and irritability documented in subjects.
18. Institutional Review Board (IRB)
Institutional review boards (IRB), also known as independent ethics
committees (IEC) in the European Union, are formally designated
independent bodies that safeguard the rights, safety, and well-being of all
human subjects involved in a trial.
The IRB has the authority to approve, require modifications prior to giving
a favorable opinion, disapprove, or terminate/suspend any prior approval
of the research.
IRBs are composed of medical and nonmedical members that have no
conflicting interest with the BE. Regulations require IRBs to have a
diverse membership, which can be in terms of race, gender, cultural
background, and community members. The recommended composition
of an IRB includes at least five members, with at least one whose primary
area of interest is in a nonscientific area, and at least one member who is
independent of the institution or trial site. Nonmembers with expertise in
special areas may be invited. The investigator may attend an IRB
19. Adverse reactions and Emergency
procedures
Adverse Events (Adverse event means any untoward medical
occurrence associated with the use of a drug in humans, whether
or not considered drug related.)
Suspect adverse reactions
Adverse Reactions (An adverse reaction means any adverse event
caused by a drug. Adverse reactions are a subset of all suspected
adverse reactions where there is reason to conclude that the drug
caused the event.)
Unexpected
Serious
Life Threatening
* 21 Code for Federal Regulation 312/320 USA