The presentation summarizes a proposed clinical trial comparing two DOTS regimens for treating tuberculosis in HIV-positive and non-HIV patients. A project team was formed with defined roles. The objectives are to select trial sites, develop necessary documents, and prepare a budget. The trial aims to compare efficacy, safety, and quality of life outcomes between the regimens over 3 years. Standard operating procedures, a risk management plan, and project schedule were developed to manage the trial.
What is ICH- GCP?
Why is GCP important?
Outline the goals of GCP
Provide a historical perspective on GCP
WHO Principles of GCP
Principles: Defines, Application & Implementation.
What is ICH- GCP?
Why is GCP important?
Outline the goals of GCP
Provide a historical perspective on GCP
WHO Principles of GCP
Principles: Defines, Application & Implementation.
When Digital Meets Medical: The Next Generation Clinical TrialCeline Pering
Proteus Digital Health is pioneering a new product paradigm at the intersection of the medical and consumer worlds. We make regulated medical products that are used by regular people in everyday life, so they need to behave more like consumer products. User research, to refine medical products, is done using highly controlled clinical trials, while great consumer products are generally created using very different design research methodologies. Attendees will learn how cross-pollination of the clinical research with the best of consumer research opens up a whole new discipline ripe for exploration.
Laura Briz Ponce, Juan A. Juanes and Francisco J. García-Peñalvo
VisualMed System
Research Group in InterAction and eLearning (GRIAL)
University of Salamanca
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.
When Digital Meets Medical: The Next Generation Clinical TrialCeline Pering
Proteus Digital Health is pioneering a new product paradigm at the intersection of the medical and consumer worlds. We make regulated medical products that are used by regular people in everyday life, so they need to behave more like consumer products. User research, to refine medical products, is done using highly controlled clinical trials, while great consumer products are generally created using very different design research methodologies. Attendees will learn how cross-pollination of the clinical research with the best of consumer research opens up a whole new discipline ripe for exploration.
Laura Briz Ponce, Juan A. Juanes and Francisco J. García-Peñalvo
VisualMed System
Research Group in InterAction and eLearning (GRIAL)
University of Salamanca
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.
La presentazione usata nel webinar dedicato alle novità del CSS introdotte con i nuovi moduli. All'interno della presentazione trovi tutte le specifiche CSS che ci mostrano la compatibilità con i browser moderni!
Puoi vedere la registrazione della LIVE a questo link: http://skillsandmore.org/futuro-css/
Webinar Series on Demystifying Phases in Clinical Trials & COVID-19 Updates organized by Institute for Clinical Research (ICR), NIH
Speaker: Dato Dr Chang Kian Meng, Haematologist from Sunway Medical Centre
More information, please visit: https://clinupcovid.mailerpage.com/resources/p9f2i7-introduction-to-phase-2-3-trial-s
Presentation on theme: "GCP (GOOD CLINICAL PRACTISE)"Nevin Francis
Creating a comprehensive 3000-word essay on Good Clinical Practice (GCP) would be quite extensive and may not fit within the scope of our conversation here. However, I can provide you with a detailed outline and key points that you could expand upon to reach the desired word count.
**Introduction to Good Clinical Practice (GCP)**
- Definition and importance of GCP in clinical research.
- Historical development and international harmonization efforts.
**Ethical Considerations in GCP**
- The role of ethics in clinical trials.
- Informed consent process and protection of participants' rights.
**Designing Clinical Trials under GCP Guidelines**
- Key elements in the design of a clinical trial.
- Considerations for protocol development.
**Conducting Clinical Trials According to GCP**
- Responsibilities of sponsors and investigators.
- Patient recruitment and data management strategies.
**Safety Monitoring and Adverse Event Reporting**
- Monitoring patient safety and reporting adverse events.
- The role of Data Safety Monitoring Boards (DSMBs).
**Quality Assurance in Clinical Trials**
- Audits, inspections, and ensuring compliance with GCP.
- The significance of documentation and record-keeping.
**Statistical Considerations in Clinical Trials**
- Importance of statistical methods in trial design and analysis.
- Interpreting results and determining clinical significance.
**The Future of GCP and Clinical Research**
- Innovations in clinical trial methodology.
- The impact of technology on GCP and patient engagement.
**Conclusion**
- The ongoing importance of GCP for the integrity of clinical research.
- The global impact of GCP on healthcare and medicine.
Each of these sections can be elaborated to create a full essay that discusses the principles and practices of GCP in depth. For the most current and detailed information, you can refer to the ICH E6 (R2) Good Clinical Practice guidelines¹, which are recognized internationally and provide a comprehensive framework for conducting clinical trials that involve human subjects. Additionally, the draft version of the ICH E6 (R3) principles provides updated guidance on ethical trial conduct, participant safety, and reliable results².
Remember, while expanding on these points, it's essential to cite relevant guidelines, regulations, and literature to support your discussion and provide a well-rounded view of GCP.
Source: Conversation with Bing, 19/02/2024
(1) ICH E6 (R2) Good clinical practice - Scientific guideline. https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice-scientific-guideline.
(2) ICH-E6 Good Clinical Practice (GCP). https://database.ich.org/sites/default/files/ICH_E6-R3_GCP-Principles_Draft_2021_0419.pdf.
(3) ICH Guidance Documents | FDA. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/ich-guidance-documents.
(4) Good Clinical Practice Guidelines (India) - Rajiv Gandhi Centre for .... https://www.rgcb.res.in/documents/Good-Clinical-Practice-Gu
MAYBE WE ALL DON'T EVEN KNOW WHAT "CLINICAL TRIAL" ACTUALLY MEANS...
I THINK THIS SLIDES WILL HELP YOU TO KNOW...
PLEASE LIKE AND FOLLOW IF OUR WORK HAVE ANSWERED YOUR QUESTIONS...
THANK YOU;)
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
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.
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
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Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
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.
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.
Are There Any Natural Remedies To Treat Syphilis.pdf
Effects of dots in HIV infected patients suffering from Tuberculosis
1. GROUP PROJECT PRESENTATION
PRESENTED BY
LEARNING GROUP 16
HUMAN WELFARE
GROUPS
TO COMAPARE THE SAFETY & EFFICACY OF TWO DIFFERENT
DOTS REGIMEN IN HIV +ve AND NON HIV PATIENTS, INFECTED
WITH TUBERCULOSIS
A Multicentre Phase III Open-Label Study
2. PROJECT OBJECTIVE
• To conduct market research for selection of
potential site and feasibility of carrying out the
trial in those sites.
• To develop all trial related ethical submission
deliverables.
• To prepare the budget for carrying out the trial.
• To develop SOPs for all trial related activities.
3. TASK DELEGATION
NAME OF THE PERSON ROLES RESPONSIBILITIES
SUBENDU MUKHERJEE PROJECT MANAGER PROTOCOL, RMP,
MEETING AGENDA’S,
SYSTEMATIC REVIEW
SARAH TAREEN DEPUTY PROJECT
MANAGER
IB, LITERATURE SEARCH
, SYSTEMATIC REVIEW
P.SHEELA CLINICAL OPERATION
MANAGER
CRF, QOL, REGULATORY
REQUIREMENTS.
PANKAJA GOHAIN ADMINISTRATIVE &
OPERATION CO-
ORDINATOR
ICF, MEDICAL
INSURANCE, SITE
FEASIBILITY CHECKLIST,
RECORDING MINUTES
OF MEETING
SUNITA KUMARI FINANCIAL PLANNER CONFIDENTIALITY
REPORT, RMP,BUDGET,
SLIDES
A.MADHURI QUALITY CONTROL &
QUALITY ASSURANCE
MANAGER
SOP’s, PRESENTATION
DAY CO-
ORDINATOR,POSTER.
4. Management plan
• Adherence to Team SOP’s
• Weekly project team status reports
• Summary of tasks completed in the previous week
• Summary of tasks scheduled for completion in the next week
• Compliance with the communication plan and Delegation plan
• Monitoring and tracking individual work
• Meeting with sponsors and reporting project progress in
periodic basis.
5. PROPOSAL STRATEGY
• Detailed literature search was done for selecting appropriate site;
sites were to be personally visited.
• Sites were to be reviewed via site selection checklist.
• Trial related essential documents were to be submitted as per
Indian GCP.
• Standard cost criteria were to be adopted for the budget.
• SOPs were to be developed in accordance with applicable
regulatory requirements, sponsor’s demands and company
standards.
7. BACKGROUND OF THE PROJECT
• In last two years 1.8 million cases of TB have been reported in
India.
• 2009 figure says, there are 2.5 million people suffering from HIV
in India.
• 26% of the cause for death in HIV infected patients is due to TB.
• No trial in India has been conducted yet.
• 95% cases of TB are reported in South India and Maharashtra
• Number of deaths per year is next to cancer and cardiac
diseases.
8. BENEFITS OF THE STUDY
• Will walkout with better health conditions..
• Study will enrich their quality of life
• Will be exposed to the best treatment to
tackle their health hazards.
Individual-
wise
• Help reduce mortality rate for developing
countries like India
• Improve the QOL for people suffering with
TB
Society-
wise
• This trial can help come up with newer
findings for DOTS regimen as only a few
trial regarding this therapy have been
conducted.
Science-
wise
11. CRITICAL CONSTRAINTS
• No previous experience in such projects
• Tasks may take longer time than expected
• Absenteeism of group member
• Loss of data
• Delay in work due to power cuts
12. PROTOCOL
• AIM : :
COMAPARE THE SAFETY & EFFICACY OF TWO DIFFERENT DOTS
REGIMEN IN HIV +ve AND NON HIV PATIENTS, INFECTED WITH
TUBERCULOSIS
• OBJECTIVE:
PRIMARY: To compare the efficacy parameters of two different DOTS
regimen in HIV and non HIV patients, in treating tuberculosis.
SECONDARY :
1. To determine the Frequency of ADR in each group of population
2. To determine the survival rate
3. To assess the quality of life of both the population
13. PROTOCOL CONTD.
• Study Design: Phase III, non-randomized, open -label, cross-over assignment,
multicentre.
• SETTINGS: BANGALORE, PUNE, CHENNAI, COCHIN, PUNE.
• SAMPLE : 9 0 0 subjects
• STUDY DURATION : 3 Years and 2 months.
• Primary Endpoints:
Reduction in mycobacterium infection in both groups, i.e., reduction in amount of
M.Tuberculli infection in sputum test, pulmonary tapping, chest x-ray
• Secondary Endpoints:
Number of ADR’s in both the groups will be collected and evaluated; number of
deaths in both the groups, periodic scores of WHO HIV tool quality of life
questionnaire will be assessed.
14. PROTOCOL CONTD.
• Safety Endpoint:
Occurrence of any ADR or SAE will be considered as safety endpoint.
• INCLUSION CRITERIA for HIV + ve + TB group:
i. Confirmed diagnosed HIV infection within last 2 years.
ii. Confirmed diagnosed TB infection – TB rapid test or sputum smear +ve for acid fast bacilli in last 2
years.
iii. Age > 18
iv. Both gender
v. Life expectancy of atleast 6 months.
vi. Should comply with all study procedures
vii. Should provide voluntary written informed consent.
Clinical parameters:
Neutrophill count > 0.75 * 109 /L
Platelet count > 50 * 109/L
Hb > 80g/L
CD4 + cells < 200 and > 80
15. PROTOCOL CONTD.
EFFICACY ASSESSMENT:
1, 2,3,4th month under both the regimen for both the study groups .
To check reduction in M. tuberculli infection from the baseline score.
Via. Sputum test, pulmonary tapping.
Chest X-ray – to check the reduction in cough.
During follow-up along with the above parameters,
survival rate and quality of life by WHO standard HIV-TB tool questionnaire will be
assessed.
• SAFETY ASSESSMENT:
• Routine safety assessment test include various test like, physical examination and vital
stats parameters. Clinical lab values of CD4 cell count. Reports of any adverse events
throughout the trial of every individual subject will be considered for safety assessment.
17. SYSTEMATIC LITERATURE REVIEW
• Comprehensive search of published article was done
• Clinical trials using rifampin, pyrazinamide, isoniazid
and rifabutin drug as investigational product were
selected
• Retrospective and prospective studies.
• No standard inclusion or exclusion criteria
• All possible databases were included- PUBMED,
NEJM, BMJ
• Keywords used for search: , tuberculosis and HIV,
DOTS regimen, treatment outcome with Rifampin,
Isoniazid, Pyrazinamide, rifabutin
18. INVESTIGATOR’S BROCHURE
• IB was prepared in accordance with the Indian GCP.
• IB included all the necessary information about the drugs used in the
study: Isoniazid, Rifampin, Rifabutin, Pyrazinamide.
• For the above mentioned drugs, along with a brief summary of each
drug, the following information was included:
• Chemical, Physical and formulation parameters.
• Data from nonclinical studies
• Data from clinical studies
• Post marketing experience of each drug
• Summary of data and guidance for the investigator
19. INFORMED CONSENT dOCUMENT
• PATIENT INFORMATION SHEET:
• Patients were formally invited for the trial
• They were informed about all the details of the trial
• Information about all the personnel involved in the trial
• INFORMED CONSENT FORM:
• A document containing all the terms and conditions related to the participation in the
trial-to be read and signed and dated by the participant or LAR.
• Investigator’s certificate declaring that the informed consent was read and signed by
the participant.
• ICF for TB in non-HIV final.doc
• ICF for TB+HIV final.doc
20. SITE SELECTION CKECKLIST
• Market research was done for selecting
potential site
• Telephonic interview was done with the
shortlisted sites
• F:SITE SELECTION CHECKLIST.docx
21. CASE REPORT FORM
• The following headings included all the
necessary information needed to be
recorded, as per the requirements of
the protocol:
• CASE REPORT FORM 2.docx
• QOL_Questionnare.docx
22. Risk management plan
Risk to participants right
• Fully IC
• Failure to protect participants privacy
Risk to participants safety
• Hazard of the trial medication
• Hazards of study assessment methods
Risk to researchers
• Staff competence / experience to carry out responsibilities
• Contact with harmful chemicals, substances, equipment or organisms
• Trial proceeding without the necessary regulatory approvals
23. RISKS TO COMPLETION OF THE TRIAL
• Study Power & Recruitment
• Organisational Complexity
• Adequacy of trial management
RISKS TO RELIABILITY OF THE RESULTS
• Study result
• Completeness and accuracy of assessment / data
• Adherence to the protocol
RISKS TO THE ORGANISATION
• Impact on clinical services
• Liability
26. Close out to include a discussion of lessons learnt
• To work as a team
• Time management
• Quality work
• Effective communication
• Understand the importance of roles and
responsibilities
• Identify and overcome the constraints