Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
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
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible (able to be believed), accurate and that the rights, integrity and confidentiality of trial subjects are protected.
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.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
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
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible (able to be believed), accurate and that the rights, integrity and confidentiality of trial subjects are protected.
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.
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
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
FOMAT Medical Research is a site research network specializes in developing clinical. We offer a wide range of solutions for Sponsors, Clinical Contract Organizations (CROs), and Sites throughout the Americas. Visit here- https://www.fomatmedical.com
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. Regulations are primarily at 21 C.F.R. 312. Similar procedures are followed in the European Union, Japan, and Canada
“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”.
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.
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
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
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
FOMAT Medical Research is a site research network specializes in developing clinical. We offer a wide range of solutions for Sponsors, Clinical Contract Organizations (CROs), and Sites throughout the Americas. Visit here- https://www.fomatmedical.com
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. Regulations are primarily at 21 C.F.R. 312. Similar procedures are followed in the European Union, Japan, and Canada
“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”.
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.
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
Un accord relatif aux modalités de fonctionnement et d'attribution de la commission paritaire nationale de l'emploi des cabinets d'avocats (IDCC 1000) a été signé le 25 novembre 2016.
L'accord précise la composition paritaire de la commission paritaire nationale de l’emploi mais aussi la qualité des représentants.
Le fonctionnement de la commission est déterminé par un règlement intérieur.
En ce qui concerne les missions de la commission, les partenaires sociaux soulignent que la CPNEFP a une attribution générale de promotion de la formation professionnelle dans son champ de compétence en liaison avec l'évolution de l'emploi dans la branche.
Les organismes patronaux signataires de l'accord sont le CNAE, la CNADA, la FNUJA, l'UPSA, le SAFE, le SEACE et l'AEF.
Les syndicats de salariés signataires de l'accord sont la CFDT, FEC-FO, CFTC-CSFV/CFTC, l'UNSA, la SPAAC-CFE-CGC et la CGT.
Transparencias utilizadas en el evento desarrollado el 21 de marzo de 2012 en CIBALL por KDE España denominado "Novedades de KDE para entornos empresariales".
Describe aspectos de interés sobre el proyecto y el software KDE para empresarios y profesionales.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
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Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Explore our infographic on 'Essential Metrics for Palliative Care Management' which highlights key performance indicators crucial for enhancing the quality and efficiency of palliative care services.
This visual guide breaks down important metrics across four categories: Patient-Centered Metrics, Care Efficiency Metrics, Quality of Life Metrics, and Staff Metrics. Each section is designed to help healthcare professionals monitor and improve care delivery for patients facing serious illnesses. Understand how to implement these metrics in your palliative care practices for better outcomes and higher satisfaction levels.
2. Presentation Outline:
Introduction
Content
1. Application to permission
2. Clinical trial
3. Studies in special population
4. Post marketing survelliance
5. Special studies-BA/BE
Conclusion
Reference
3. INTRODUCTION
What is Schedule Y?
Requirements and guidelines for permission to import and/or manufacture of
new drugs for sale or to undertake clinical trials.
Purpose of Schedule Y
To frame guidelines for conduct of clinical research
Control and regulation for new drugs
CDSCO and DTAB formulated GCP under schedule Y in 2005
Why India
Large patient pool
Well trained and experienced Investigators.
Considerable low per patient trial cost, as compared to developed countries.
4. Drugs and Cosmetics Act 1945
Rule
122 A
122 B
122 D
122 DA
122DAA
122 E
Permission for
To Import New Drugs
To manufacture New Drugs
To import or manufacture fixed dose
Combinations
To conduct Clinical Trials
for New Drug/Investigational New
Drug
Definition of Clinical Trial
Definition of New Drug
5. Requirements and guidelines on Clinical Trials for import and
manufacture of New Drug
1. Application for permission
2. Clinical Trial
3. Studies in special population
4. Post Marketing surveillance
5. Special Studies: BA/BE studies
6. 1. Application for permissionApplication for permission
It shall made in FORM 44 accompanied with following data in accordance with appendices , namely
1. Chemical and Pharmaceutical Information
2. Animal Pharmacology data
3. Animal Toxicology data
4. Human Clinical Pharmacology data
5. Regulatory status in other countries
6. Prescribing Information
FORM 12- To import Study drug for examination, test or analysis
7. 2.2.Clinical TrialClinical Trial
1.Approval for clinical trials
CT on a new drug shall be initiated only after permission by licensing authority and approval from
EC.
2.Responsibilities of sponsor
Implementing and Maintaining QA.
Submit status report to the licensing authority periodically.
SAE should be reported to the licensing authority within 14 calendar days.
3.Responsibilities of Investigator
Ensure adequate medical care is provided to the subject.
SAE and unexpected AE should be reported to the sponsor within 24hours and to the EC within
7 working days.
4.Informed Consent
freely given informed written consent.
Provide information about the study verbally.
Non-technical and understandable language.
8. 5.Responsibilities of Ethics Committee
Approval trial protocol to safeguard of all trial subject and to protect all vulnerable subjects
Conduct ongoing review of the trials.
6.Human Pharmacology (Phase l)
Safety and tolerability – Objective
7.Therapeutic Exploratory Trials (Phase ll)
To evaluate the effectiveness of a drug for particular indication.
To determine the short term side effects and risk associated with the drug
To determine the dose and regimen for phase lll trials.
8.Therapeutic confirmatory Trials (Phase lll)
Demonstration of therapeutic benefit
Drug is safe and effective for use and Provide and adequate basis for marketing approval.
9.Post Marketing Trials (Phase lV)
Performed after drug approval and related to the approved indication
Includes drug-drug interaction, dose-response or safety studies, mortality/morbidity studies.
9. 3.Studies in Special Population:
. 1. Geriatrics
2. Pediatrics
3. Pregnant or Nursing Women
4.Post Marketing Surveillance:
Closely monitored new drugs clinical safety
PSUR- to report all relevant new information
PSUR shall be submitted every 6 months for the first 2 years.
5.Special Studies-BA/BE studies:
Conducted according to the guidelines for BA and BE studies.
Evaluation of the effect of food on absorption following oral administration.
10. Conclusion:Conclusion:
With the Schedule Y, efforts are aligned in a single
direction to ensure that irrespective of the Country,
the data generated is of good quality & Standard
which can be accepted Worldwide.