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
A presentation on INFORMED CONSENT FORM which is easy to understand and easy to explain and in very understandable language. Do give it a heart if you like this presentation and do give your valuable comments on it. I will be reading them all. Do contact me if you want some other presentation related to pharmaceutical science.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
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
A presentation on INFORMED CONSENT FORM which is easy to understand and easy to explain and in very understandable language. Do give it a heart if you like this presentation and do give your valuable comments on it. I will be reading them all. Do contact me if you want some other presentation related to pharmaceutical science.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
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.
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
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.
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Informed consent is a process in which a patient or research participant is provided with information about a medical procedure or research study, including its risks and benefits, in order to make an informed decision about whether or not to participate. The informed consent process is a critical component of ethical medical practice and research and is intended to protect the rights and welfare of patients and research participants.
Here are some key elements of the informed consent process:
Information: The patient or research participant must be provided with information about the medical procedure or research study, including its purpose, procedures, risks, benefits, and alternatives.
Capacity: The patient or research participant must have the capacity to understand the information provided and make a decision based on that understanding.
Voluntariness: The decision to participate must be made voluntarily, without coercion or undue influence.
Documentation: The informed consent process must be documented in writing, including the information provided, the decision made, and any questions or concerns raised by the patient or research participant.
Ongoing consent: Informed consent is an ongoing process and must be re-evaluated if there are changes to the procedure or study, or if new information becomes available.
Consent for minors: In the case of minors, informed consent must be obtained from a legal guardian or parent.
The informed consent process is a fundamental aspect of ethical medical practice and research. It ensures that patients and research participants are fully informed about the procedures and risks involved and that they have the opportunity to make an informed decision about whether or not to participate.
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
inform consent form in clinical research process.defination of inform consent form .documents required for inform consent form
elements required for inform consent form
The Declaration of Helsinki is a set of ethical principles and guidelines for medical research involving human subjects. It was first adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times, with the most recent version released in 2013. The Declaration provides a framework to protect the rights, safety, and well-being of individuals participating in research studies. Here are the key elements of the Declaration of Helsinki:
Respect for Autonomy and Informed Consent: The Declaration emphasizes the importance of respecting the autonomy of individuals and their right to make informed decisions about participating in research. It requires researchers to obtain informed consent from participants or their legally authorized representatives, ensuring they have been adequately informed about the study's purpose, procedures, potential risks and benefits, and their right to withdraw at any time.
Beneficence and Risk Assessment: Researchers have a responsibility to maximize potential benefits and minimize potential harm to research participants. The Declaration states that research protocols should be based on a thorough scientific assessment of risks and benefits and should prioritize the well-being of participants.
Ethical Review and Approval: The Declaration highlights the necessity of independent ethical review of research protocols by an appropriate research ethics committee or institutional review board (IRB). The committee should ensure that the study is scientifically valid, ethically sound, and compliant with relevant regulations and guidelines.
Privacy and Confidentiality: The Declaration emphasizes the importance of protecting the privacy and confidentiality of research participants. Researchers should ensure that participants' personal information is kept confidential, and data should be anonymized or pseudonymized whenever possible to protect participant identities.
Data and Safety Monitoring: The Declaration emphasizes the importance of ongoing data monitoring and safety assessments during the research study. Researchers should have plans in place to detect and manage any adverse events or unanticipated risks that may arise during the study.
Vulnerable Populations: Special protections are outlined for vulnerable populations, such as children, pregnant women, prisoners, and individuals with impaired decision-making capacity. Researchers should take extra precautions to ensure their well-being, and their involvement in research should be justified based on the potential benefits to their own population.
Publication and Dissemination of Results: The Declaration emphasizes the responsibility of researchers to publish and share the results of their research in a timely manner. The results should be accurately reported, and negative or inconclusive results should also be disseminated to prevent publication bias.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
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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
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
2. What is Informed Consent?
Informed consent is first and foremost a continuing
process. This includes a person voluntarily agreeing to
participate in a research study after being fully
informed about it via verbal discussion with study staff,
followed by documentation in a written, signed, and
dated informed consent form.
A participant’s consent will be continually sought during
the course of the study, and the participant will be
notified of any changes to the study, along with any
other pertinent information that may influence their
decision to remain in the study
3. All researchers must ensure that the process of
obtaining informed consent from study participants
not only conforms to federal, state, and local
regulations but also respects each individual’s right
to make a voluntary, informed decision.
4. The Informed Consent Document
1. Study Purpose:
The consent document must state :
• That the trial involves research.
• The purpose of the trial.
2. Study Treatment and Randomization
The consent document must state :
• The trial treatment and the probability for random
assignment to each treatment (if a randomized clinical
trial).
3. Study Procedures
The consent document must state :
• The trial procedures to be followed, including all invasive
procedures.
• The participant’s responsibilities.
• Those aspects of the trial that are experimental.
5. 4. Risks of Taking Part in the Study
The consent document must state :
• The reasonably foreseeable risks or inconveniences to
the participant and, when applicable, to an embryo, fetus,
or nursing infant.
5. Benefits of Taking Part in the Study
The consent document must state :
• The reasonably expected benefits. When there is no
intended clinical benefit to the participant, the participant
should be made aware of this.
6. Alternatives to Taking Part in the Study
The consent document must state :
• The alternative procedure(s) or course(s) of treatment
that may be available to the participant, and their
important potential benefits and risks.
6. 7. Costs of Participation and Compensation in the Event of
Injury
The consent document must state :
• The compensation and/or treatment available to the
participant in the event of trial-related injury. The
anticipated expenses, if any, to the participant for
participating in the trial.
8. Payment for Taking Part in the Study
The consent document must state :
• The anticipated prorated payment, if any, to the
participant for participating in the trial.
9. Voluntary Nature of Study
The consent document must state :
• That the participant’s participation in the trial is voluntary
and that the participant may refuse to participate or
withdraw from the trial, at any time, without penalty or
loss of benefits to which the participant is otherwise
7. 10. Confidentiality of Personal Information
The consent document must state :
• That the monitor(s), the auditor(s), the IRB, and the
regulatory authority will be granted direct access to the
participant’s original medical records for verification of
clinical trial procedures and/or data, without violating the
confidentiality of the participant, to the extent permitted
by the applicable laws and regulations and that, by
signing a written informed consent form, the participant
or the participant’s legal representative is authorizing
such access.
11. New Information that may Affect Study Participation
The consent document must state :
• That the participant or the participant’s legally
acceptable representative will be informed in a timely
manner if information becomes available that may be
relevant to the participant’s willingness to continue
8. 12. Study Contacts
The consent document must state :
• The person(s) to contact for further information
regarding the trial and the rights of trial participants in
the event of trial-related injury.
13. Duration of Participation and Number of People
Taking Part in the Study
The consent document must state :
• The expected duration of the participant's participation
in the trial. The approximate number of participants
involved in the trial.
9.
10. Elements of the Informed Consent
Process:
To be valid, informed consent must be based on the
following:
1)Capacity to Give Informed Consent
A person who has a court-appointed legal guardian or who has
been determined by a court to be legally incompetent cannot
sign an Informed Consent Form even if he or she has the
capacity to make a decision. This determination is made by the
legal system and not by clinicians.
2) Disclosure of all Relevant Information
This information generally includes:
• The purpose of the study.
• The nature of the procedure or intervention that is being
studied.
• The potential risks and benefits as well as the uncertainties of
study participation.
• Reasonable alternatives to participation in the study.
• The participants obligations for the duration of the study.
11. 3)Comprehension by the Participant
The potential participant must understand the
information disclosed to him or her about the research
study. The participant is free to ask questions to the
study team as well as take additional time to make a
decision regarding participation.
4)Voluntary Agreement by the Participant
The participant must agree to participate in the
research study and his or her agreement must be
voluntary and free from coercion or undue influence.
5)Right to Withdraw
The participant must be informed that he or she has a
right to withdraw from the study at any time and for any
reason, without penalty or loss of benefits that he or she
would otherwise be entitled to receive.
12. Documentation of informed consent:
Documentation of informed consent is the conclusion
of initial consent process. Whoever documents the
obtainment of informed consent must be qualified to
attest to the fact that the subject has provided legally
effective informed consent. While a number of
qualified research personnel can, and should, be
involved in the process of the consent, it should be
remembered that the principal Investigator(PI) is
ultimately responsible for all aspects of the research
including informed consent. Therefore, it is incumbent
upon the PI to be involved in both the process and
documentation of informed consent, particularly in
studies involving investigational drugs or devices
under an IDE(Investigational device exemption)
13. Quality Control in the Informed Consent
Process:
Protection of human research participants is the primary
goal of the IRB and the informed consent process.
Failure to comply with general requirements for informed
consent and documentation of informed consent may
result in suspension of a study. Errors in the informed
consent process are considered protocol violations and,
as such, must be reported to the relevant IRBs, along
with a description of the action taken to correct the error
and prevent it from occurring again.
ex : The Original Consent Form Has Been Lost
How did this happen?
How can this error be prevented?
and Corrective Action
14. Ongoing consent:
Compliance with regulations as well as ethical
conduct of research requires that subjects be
informed of new findings that may influence their
continued participation in the research .
In certain instances it is appropriate to actively
seek continued permission/consent from the
subjects. A subjects preferences and interests
may change overtime, even in the absence of
material changes it the research protocol.
Therefore, while regulations do not require re-
consent, good ethics may depending on the
nature of the research the PI should ensure that
the re-consent is obtained at regular various
intervals in the study.
15. Conclusion:
Respect for persons demands that legally
effective informed consent be obtained from
subjects before they participate in research.
Indeed, informed consent may be the most
important protection for human subjects
participating in the clinical trial studies.
16. The information that must be provided in an
informed consent document is specified in(US
FDA) 45 CFR 46.116, 21 CFR 50.20, and ICH
GCP 4.8.10.
45 CFR 46.116 & 21 CFR 50.20 - General
requirements for informed consent.
17. ICH GCP 4.8.10 GUIDELINES:
Both the informed consent discussion and the written
informed consent form and any other written information to
be provided to subjects should include explanations of the
following:
(a) That the trial involves research.
(b) The purpose of the trial.
(c) The trial treatment(s) and the probability for random
assignment to each treatment.
(d) The trial procedures to be followed, including all
invasive procedures.
(e) The subject's responsibilities.
(f) Those aspects of the trial that are experimental.
(g) The reasonably foreseeable risks or inconveniences to
the subject and, when applicable, to an embryo, fetus, or
nursing infant.
(h) The reasonably expected benefits. When there is no
intended clinical benefit to the subject, the subject should
be made aware of this.
18. (j) The compensation and/or treatment available to
the subject in the event of trial-related injury.
(k) The anticipated prorated payment, if any, to the
subject for participating in the trial.
(l) The anticipated expenses, if any, to the subject for
participating in the trial.
(m) That the subject's participation in the trial is
voluntary and that the subject may refuse to
participate or withdraw from the trial, at any time,
without penalty or loss of benefits to which the subject
is otherwise entitled.
(n) That the monitor(s), the auditor(s), the IRB/IEC,
and the regulatory authority will be granted direct
access to the subject's original medical records for
verification of clinical trial procedures and/or data,
without violating the confidentiality of the subject, to
the extent permitted by the applicable laws and
regulations and that, by signing a written informed
19. the subject's legally acceptable representative is
authorizing such access.
(o) That records identifying the subject will be kept
confidential and, to the extent permitted by the
applicable laws and/or regulations, will not be made
publicly available. If the results of the trial are
published, the subject’s identity will remain
confidential.
(p) That the subject or the subject's legally acceptable
representative will be informed in a timely manner if
information becomes available that may be relevant to
the subject's willingness to continue participation in
the trial.
(q) The person(s) to contact for further information
regarding the trial and the rights of trial subjects, and
whom to contact in the event of trial-related injury.
(r) The foreseeable circumstances and/or reasons
under which the subject's participation in the trial may
be terminated.
(s) The expected duration of the subject's participation