This document summarizes the key guidelines of ICH GCP (E6), which provides a unified quality standard for clinical trials involving human subjects. It outlines standards for clinical trial design, conduct, oversight and reporting. The objectives are to protect subject rights and safety, and ensure credibility of trial data. Key sections describe principles of GCP, responsibilities of investigators, sponsors and oversight bodies like IRBs/IECs, requirements for protocols, informed consent, safety reporting and essential trial documents. Compliance with GCP provides public assurance that trial data can be relied upon to support regulatory approval.
The presentation on ICHGCP guidelines overview.The presentation gives a detailed view of What is ICHGCP, Principles of ICH & GCP
IRB & IEC, Investigator, Sponsor, Clinical trial Protocol
Investigator brochures & Essential documents.
The document provides guidelines on International Conference on Harmonization-Good Clinical Practice (ICH-GCP). It discusses the aims and objectives of ICH-GCP which are to ensure clinical trials are scientifically and ethically sound. It describes the origin and development of GCP from the Nuremberg Code and Declaration of Helsinki. The key sections of ICH-GCP are summarized, including the responsibilities of ethics committees, investigators, sponsors, and the components of clinical trial protocols. In summary, the document outlines the international standards for conducting clinical research involving human subjects in a safe, ethical and rigorous manner.
Assignment on Regulatory Prespectives of Clinical TrialsDeepak Kumar
Assignment on Origin and Principles of International Conference on Harmonization - Good Clinical Practice, (ICH-GCP) guidelines Ethical Committee- Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR
This document provides an overview of ICH E6(R1) guidelines for good clinical practice. The key points are:
1. ICH E6(R1) provides ethical and quality standards for clinical trial design, conduct, recording and reporting to protect subject rights and ensure data credibility.
2. The guidelines aim to harmonize standards across Europe, Japan and the US to facilitate mutual acceptance of clinical data by regulatory authorities.
3. The document outlines principles like prioritizing subject safety, obtaining informed consent, and ensuring trial conduct follows approved protocols.
4. It also describes responsibilities of parties involved like investigators, sponsors, and ethics committees. Proper documentation and oversight are important to demonstrate
The document provides an overview of ICH GCP guidelines. It defines ICH GCP as standards that ensure clinical trial data and results are credible and accurate, and protect subject rights and confidentiality. It summarizes key responsibilities of sponsors, such as overseeing trial conduct and monitoring, and of investigators, such as obtaining informed consent and maintaining accurate records. Adverse events and serious adverse events are also defined.
institutional review board and independent ethics committeeMOHAMMAD ASIM
The document discusses the role and responsibilities of institutional review boards (IRBs) in protecting human subjects in clinical research. It provides details on:
- The composition and quorum requirements of IRBs, including the need for diverse expertise and community representation.
- The functions of IRBs, which include reviewing research protocols, approving studies, overseeing informed consent processes, and ensuring ongoing ethical review of approved studies.
- The responsibilities of IRBs in evaluating risks and benefits to research participants, assessing payment amounts and methods, and requiring modifications or halting studies when necessary.
- The necessary components of informed consent forms used in clinical studies, including study details, risks/benefits, confidentiality
Investigators Responsibilities during Clinical trialsBHAVYARAJAN2
This Presentation was presented by Pruthvi raj, Tejaswini, and myself Bhavya Rajan at Clinosol Research Pvt Ltd. We would like to thank Clinosol and Mujeeb sir for this opportunity. for constantly supporting and encouraging us
The presentation on ICHGCP guidelines overview.The presentation gives a detailed view of What is ICHGCP, Principles of ICH & GCP
IRB & IEC, Investigator, Sponsor, Clinical trial Protocol
Investigator brochures & Essential documents.
The document provides guidelines on International Conference on Harmonization-Good Clinical Practice (ICH-GCP). It discusses the aims and objectives of ICH-GCP which are to ensure clinical trials are scientifically and ethically sound. It describes the origin and development of GCP from the Nuremberg Code and Declaration of Helsinki. The key sections of ICH-GCP are summarized, including the responsibilities of ethics committees, investigators, sponsors, and the components of clinical trial protocols. In summary, the document outlines the international standards for conducting clinical research involving human subjects in a safe, ethical and rigorous manner.
Assignment on Regulatory Prespectives of Clinical TrialsDeepak Kumar
Assignment on Origin and Principles of International Conference on Harmonization - Good Clinical Practice, (ICH-GCP) guidelines Ethical Committee- Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR
This document provides an overview of ICH E6(R1) guidelines for good clinical practice. The key points are:
1. ICH E6(R1) provides ethical and quality standards for clinical trial design, conduct, recording and reporting to protect subject rights and ensure data credibility.
2. The guidelines aim to harmonize standards across Europe, Japan and the US to facilitate mutual acceptance of clinical data by regulatory authorities.
3. The document outlines principles like prioritizing subject safety, obtaining informed consent, and ensuring trial conduct follows approved protocols.
4. It also describes responsibilities of parties involved like investigators, sponsors, and ethics committees. Proper documentation and oversight are important to demonstrate
The document provides an overview of ICH GCP guidelines. It defines ICH GCP as standards that ensure clinical trial data and results are credible and accurate, and protect subject rights and confidentiality. It summarizes key responsibilities of sponsors, such as overseeing trial conduct and monitoring, and of investigators, such as obtaining informed consent and maintaining accurate records. Adverse events and serious adverse events are also defined.
institutional review board and independent ethics committeeMOHAMMAD ASIM
The document discusses the role and responsibilities of institutional review boards (IRBs) in protecting human subjects in clinical research. It provides details on:
- The composition and quorum requirements of IRBs, including the need for diverse expertise and community representation.
- The functions of IRBs, which include reviewing research protocols, approving studies, overseeing informed consent processes, and ensuring ongoing ethical review of approved studies.
- The responsibilities of IRBs in evaluating risks and benefits to research participants, assessing payment amounts and methods, and requiring modifications or halting studies when necessary.
- The necessary components of informed consent forms used in clinical studies, including study details, risks/benefits, confidentiality
Investigators Responsibilities during Clinical trialsBHAVYARAJAN2
This Presentation was presented by Pruthvi raj, Tejaswini, and myself Bhavya Rajan at Clinosol Research Pvt Ltd. We would like to thank Clinosol and Mujeeb sir for this opportunity. for constantly supporting and encouraging us
The document discusses the roles and responsibilities of an Institutional Review Board (IRB) in protecting human subjects in clinical research. It describes the composition of an IRB including required member types and qualifications. The IRB's functions include reviewing and approving research protocols, informed consent forms, and ensuring risks to subjects are minimized while research is conducted ethically.
The document discusses the roles and responsibilities of an Institutional Review Board (IRB) in protecting human subjects in clinical research. It outlines that the IRB reviews research protocols, ensures ethical standards are upheld, and provides oversight of informed consent processes. The IRB should have at least seven qualified members and meet quorum requirements. It is responsible for initial and ongoing review of research and for notifying investigators of its decisions. Informed consent forms must provide all key information about research risks, benefits, procedures, and subjects' rights in language they can understand.
This presentation focuses on Institutional Review Board/ Institutional Ethics Committee, Informed Consent Form and Protocol for a Research. The responsibilities of various personals have also been covered.
The document discusses the ICH GCP guidelines for conducting clinical trials. The key points are:
1) GCP guidelines provide ethical and quality standards for clinical trial conduct to protect subject safety and ensure data credibility.
2) The guidelines establish responsibilities for investigators, sponsors, and ethics committees to follow principles where subject welfare prevails over science and trials must be scientifically sound.
3) The ICH facilitates harmonization across countries/regions to streamline drug development and avoid duplicative trials through consensus guidelines.
Role and Responsiblities of Sponsor as per ICH GCP.pptxsreesujithra
The sponsor is responsible for the overall conduct of the clinical trial according to GCP guidelines. This includes proper trial design, monitoring, data handling, record keeping, reporting safety issues and audit. The sponsor designates appropriate medical and scientific experts to oversee the trial. It also selects and monitors investigators and ensures ethics committee approval and participant consent are obtained. The sponsor manufactures, supplies and handles the investigational product and maintains its quality. It is responsible for reporting adverse events and trial results to regulatory authorities.
This educational module describes Good Clinical Practice (GCP) standards developed by ICH for conducting clinical trials involving human subjects ethically and scientifically. It provides guidance to investigators on their roles and responsibilities, including obtaining informed consent, complying with protocols, safety reporting, and maintaining accurate records. Adherence to GCP assures trial credibility and subjects' well-being consistent with the Declaration of Helsinki.
Investigators play a crucial role in conducting clinical research studies and ensuring the integrity, safety, and ethical conduct of the trials. Here are some key responsibilities of investigators in clinical research
The document outlines the responsibilities of investigators conducting clinical trials. It discusses that investigators should be qualified, have adequate resources, provide medical care for subjects, communicate with regulatory bodies, comply with the study protocol, ensure drug accountability, obtain informed consent, maintain accurate records and reports, and promptly report safety issues. Investigators are responsible for the conduct of the trial and protection of subject safety and rights.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
The document discusses regulations related to good clinical practices (GCPs) and good manufacturing practices (GMPs). It provides background on the history and development of GCPs and GMPs, which were created to harmonize standards across countries and ensure safety, quality and efficacy in clinical trials and manufacturing. The core principles of GCPs are described, including ethical treatment of subjects, scientific validity of trials, and quality management. Key aspects of clinical trials such as institutional review boards, investigators, sponsors and essential documents are also covered. The presentation concludes with an introduction to GMPs and descriptions of documentation requirements, production controls and other quality standards they aim to ensure.
The document outlines the key roles and responsibilities of an investigator in clinical research. It discusses that the investigator is responsible for ensuring ethical conduct of the research study, obtaining informed consent, overseeing all aspects of the clinical trial from design to results. The investigator must qualify by training and experience, submit required documents to the IRB for review, monitor the trial, report adverse events, interact with subjects, and assist in audits. The investigator plays a critical role in successfully meeting research expectations and regulatory requirements.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
The document outlines the roles and responsibilities of sponsors according to ICH-GCP guidelines. It discusses that sponsors are responsible for initiating, managing, financing, and monitoring clinical trials. They must ensure trials are conducted according to GCP standards, applicable regulations, and the approved protocol. Sponsors are also responsible for safety monitoring, reporting adverse events, quality assurance, selecting and compensating investigators, and maintaining required trial documentation.
Roles and responsibilities of investigatorPavani555
This document defines key roles in clinical trials including sponsors, investigators, clinical research associates (CRAs), auditors, contract research coordinators, and regulatory authorities. Sponsors are responsible for initiating, managing, and financing trials. Investigators conduct trials and ensure participant safety and protocol compliance. CRAs monitor trials to ensure data quality and safety reporting. Auditors ensure compliance with regulations. Coordinators record trial data. Regulatory authorities review trials and ensure drug safety.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
ROLES AND RESPONSIBILITIES OF sponsor and CRO.pptxPraveen kumar S
The document discusses the roles and responsibilities of clinical trial sponsors and contract research organizations (CROs). It outlines that sponsors are responsible for initiating, managing, and financing clinical trials in accordance with good clinical practice guidelines. They must select investigators, monitor trials, ensure regulatory approval is obtained, and address safety issues. CROs assist sponsors by providing outsourced clinical research services like monitoring, data management, and regulatory support. Sponsors and CROs have legal contracts defining their responsibilities for conducting research properly and protecting participant safety.
This document provides a summary of guidelines for good clinical practice (GCP) according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It discusses the purpose and scope of GCP, which is to ensure proper design, conduct, and reporting of clinical trials involving human subjects. Key topics covered include ethics review, responsibilities of investigators and sponsors, informed consent of subjects, clinical trial documentation and record keeping. The document emphasizes protecting the rights, safety and well-being of clinical trial subjects.
INDIAN GCP GUIDELINE. for Regulatory affair 1st sem CRRsarwankumar4524
This document provides an overview of the Indian GCP guideline. It discusses key aspects of GCP including principles, the role of the independent ethics committee, informed consent process, responsibilities of sponsors, investigators and monitors, special considerations for vulnerable populations in clinical trials, and comparisons between Indian GCP and ICH GCP.
The document discusses the various stakeholders involved in clinical trials and their responsibilities. The key stakeholders mentioned are sponsors, investigators, study subjects/patients, monitors, ethics committees, and regulatory authorities.
It provides details on the responsibilities of sponsors such as quality control, trial design, compensation, safety reporting, and submitting the study report. Investigator responsibilities include protocol compliance, medical care of subjects, record keeping, and safety reporting. Ethics committees are responsible for reviewing trials and protecting subject rights and safety. Study subjects must meet eligibility criteria and provide informed consent. Monitors ensure compliance by investigating sites. Regulatory authorities review and approve clinical trial applications.
Schedule Y is the law in India that regulates clinical trials. It was established in 1988 under the Drugs and Cosmetics Act and amended in 2005 to better protect citizens and ensure data is acceptable internationally. Schedule Y outlines requirements for permission to import or manufacture new drugs and conduct clinical trials. It describes the responsibilities of sponsors, investigators, and ethics committees. It provides guidelines for informed consent, different trial phases, and special populations. Overall, Schedule Y aims to enable stringent yet favorable regulations for clinical trials in India.
The document discusses the roles and responsibilities of an Institutional Review Board (IRB) in protecting human subjects in clinical research. It describes the composition of an IRB including required member types and qualifications. The IRB's functions include reviewing and approving research protocols, informed consent forms, and ensuring risks to subjects are minimized while research is conducted ethically.
The document discusses the roles and responsibilities of an Institutional Review Board (IRB) in protecting human subjects in clinical research. It outlines that the IRB reviews research protocols, ensures ethical standards are upheld, and provides oversight of informed consent processes. The IRB should have at least seven qualified members and meet quorum requirements. It is responsible for initial and ongoing review of research and for notifying investigators of its decisions. Informed consent forms must provide all key information about research risks, benefits, procedures, and subjects' rights in language they can understand.
This presentation focuses on Institutional Review Board/ Institutional Ethics Committee, Informed Consent Form and Protocol for a Research. The responsibilities of various personals have also been covered.
The document discusses the ICH GCP guidelines for conducting clinical trials. The key points are:
1) GCP guidelines provide ethical and quality standards for clinical trial conduct to protect subject safety and ensure data credibility.
2) The guidelines establish responsibilities for investigators, sponsors, and ethics committees to follow principles where subject welfare prevails over science and trials must be scientifically sound.
3) The ICH facilitates harmonization across countries/regions to streamline drug development and avoid duplicative trials through consensus guidelines.
Role and Responsiblities of Sponsor as per ICH GCP.pptxsreesujithra
The sponsor is responsible for the overall conduct of the clinical trial according to GCP guidelines. This includes proper trial design, monitoring, data handling, record keeping, reporting safety issues and audit. The sponsor designates appropriate medical and scientific experts to oversee the trial. It also selects and monitors investigators and ensures ethics committee approval and participant consent are obtained. The sponsor manufactures, supplies and handles the investigational product and maintains its quality. It is responsible for reporting adverse events and trial results to regulatory authorities.
This educational module describes Good Clinical Practice (GCP) standards developed by ICH for conducting clinical trials involving human subjects ethically and scientifically. It provides guidance to investigators on their roles and responsibilities, including obtaining informed consent, complying with protocols, safety reporting, and maintaining accurate records. Adherence to GCP assures trial credibility and subjects' well-being consistent with the Declaration of Helsinki.
Investigators play a crucial role in conducting clinical research studies and ensuring the integrity, safety, and ethical conduct of the trials. Here are some key responsibilities of investigators in clinical research
The document outlines the responsibilities of investigators conducting clinical trials. It discusses that investigators should be qualified, have adequate resources, provide medical care for subjects, communicate with regulatory bodies, comply with the study protocol, ensure drug accountability, obtain informed consent, maintain accurate records and reports, and promptly report safety issues. Investigators are responsible for the conduct of the trial and protection of subject safety and rights.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
The document discusses regulations related to good clinical practices (GCPs) and good manufacturing practices (GMPs). It provides background on the history and development of GCPs and GMPs, which were created to harmonize standards across countries and ensure safety, quality and efficacy in clinical trials and manufacturing. The core principles of GCPs are described, including ethical treatment of subjects, scientific validity of trials, and quality management. Key aspects of clinical trials such as institutional review boards, investigators, sponsors and essential documents are also covered. The presentation concludes with an introduction to GMPs and descriptions of documentation requirements, production controls and other quality standards they aim to ensure.
The document outlines the key roles and responsibilities of an investigator in clinical research. It discusses that the investigator is responsible for ensuring ethical conduct of the research study, obtaining informed consent, overseeing all aspects of the clinical trial from design to results. The investigator must qualify by training and experience, submit required documents to the IRB for review, monitor the trial, report adverse events, interact with subjects, and assist in audits. The investigator plays a critical role in successfully meeting research expectations and regulatory requirements.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
The document outlines the roles and responsibilities of sponsors according to ICH-GCP guidelines. It discusses that sponsors are responsible for initiating, managing, financing, and monitoring clinical trials. They must ensure trials are conducted according to GCP standards, applicable regulations, and the approved protocol. Sponsors are also responsible for safety monitoring, reporting adverse events, quality assurance, selecting and compensating investigators, and maintaining required trial documentation.
Roles and responsibilities of investigatorPavani555
This document defines key roles in clinical trials including sponsors, investigators, clinical research associates (CRAs), auditors, contract research coordinators, and regulatory authorities. Sponsors are responsible for initiating, managing, and financing trials. Investigators conduct trials and ensure participant safety and protocol compliance. CRAs monitor trials to ensure data quality and safety reporting. Auditors ensure compliance with regulations. Coordinators record trial data. Regulatory authorities review trials and ensure drug safety.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
ROLES AND RESPONSIBILITIES OF sponsor and CRO.pptxPraveen kumar S
The document discusses the roles and responsibilities of clinical trial sponsors and contract research organizations (CROs). It outlines that sponsors are responsible for initiating, managing, and financing clinical trials in accordance with good clinical practice guidelines. They must select investigators, monitor trials, ensure regulatory approval is obtained, and address safety issues. CROs assist sponsors by providing outsourced clinical research services like monitoring, data management, and regulatory support. Sponsors and CROs have legal contracts defining their responsibilities for conducting research properly and protecting participant safety.
This document provides a summary of guidelines for good clinical practice (GCP) according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It discusses the purpose and scope of GCP, which is to ensure proper design, conduct, and reporting of clinical trials involving human subjects. Key topics covered include ethics review, responsibilities of investigators and sponsors, informed consent of subjects, clinical trial documentation and record keeping. The document emphasizes protecting the rights, safety and well-being of clinical trial subjects.
INDIAN GCP GUIDELINE. for Regulatory affair 1st sem CRRsarwankumar4524
This document provides an overview of the Indian GCP guideline. It discusses key aspects of GCP including principles, the role of the independent ethics committee, informed consent process, responsibilities of sponsors, investigators and monitors, special considerations for vulnerable populations in clinical trials, and comparisons between Indian GCP and ICH GCP.
The document discusses the various stakeholders involved in clinical trials and their responsibilities. The key stakeholders mentioned are sponsors, investigators, study subjects/patients, monitors, ethics committees, and regulatory authorities.
It provides details on the responsibilities of sponsors such as quality control, trial design, compensation, safety reporting, and submitting the study report. Investigator responsibilities include protocol compliance, medical care of subjects, record keeping, and safety reporting. Ethics committees are responsible for reviewing trials and protecting subject rights and safety. Study subjects must meet eligibility criteria and provide informed consent. Monitors ensure compliance by investigating sites. Regulatory authorities review and approve clinical trial applications.
Schedule Y is the law in India that regulates clinical trials. It was established in 1988 under the Drugs and Cosmetics Act and amended in 2005 to better protect citizens and ensure data is acceptable internationally. Schedule Y outlines requirements for permission to import or manufacture new drugs and conduct clinical trials. It describes the responsibilities of sponsors, investigators, and ethics committees. It provides guidelines for informed consent, different trial phases, and special populations. Overall, Schedule Y aims to enable stringent yet favorable regulations for clinical trials in India.
Mental Health and well-being Presentation. Exploring innovative approaches and strategies for enhancing mental well-being. Discover cutting-edge research, effective strategies, and practical methods for fostering mental well-being.
This particular slides consist of- what is Pneumothorax,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is a summary of Pneumothorax:
Pneumothorax, also known as a collapsed lung, is a condition that occurs when air leaks into the space between the lung and chest wall. This air buildup puts pressure on the lung, preventing it from expanding fully when you breathe. A pneumothorax can cause a complete or partial collapse of the lung.
End-tidal carbon dioxide (ETCO2) is the level of carbon dioxide that is released at the end of an exhaled breath. ETCO2 levels reflect the adequacy with which carbon dioxide (CO2) is carried in the blood back to the lungs and exhaled.
Non-invasive methods for ETCO2 measurement include capnometry and capnography. Capnometry provides a numerical value for ETCO2. In contrast, capnography delivers a more comprehensive measurement that is displayed in both graphical (waveform) and numerical form.
Sidestream devices can monitor both intubated and non-intubated patients, while mainstream devices are most often limited to intubated patients.
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CHAPTER 1 SEMESTER V COMMUNICATION TECHNIQUES FOR CHILDREN.pdfSachin Sharma
Here are some key objectives of communication with children:
Build Trust and Security:
Establish a safe and supportive environment where children feel comfortable expressing themselves.
Encourage Expression:
Enable children to articulate their thoughts, feelings, and experiences.
Promote Emotional Understanding:
Help children identify and understand their own emotions and the emotions of others.
Enhance Listening Skills:
Develop children’s ability to listen attentively and respond appropriately.
Foster Positive Relationships:
Strengthen the bond between children and caregivers, peers, and other adults.
Support Learning and Development:
Aid cognitive and language development through engaging and meaningful conversations.
Teach Social Skills:
Encourage polite, respectful, and empathetic interactions with others.
Resolve Conflicts:
Provide tools and guidance for children to handle disagreements constructively.
Encourage Independence:
Support children in making decisions and solving problems on their own.
Provide Reassurance and Comfort:
Offer comfort and understanding during times of distress or uncertainty.
Reinforce Positive Behavior:
Acknowledge and encourage positive actions and behaviors.
Guide and Educate:
Offer clear instructions and explanations to help children understand expectations and learn new concepts.
By focusing on these objectives, communication with children can be both effective and nurturing, supporting their overall growth and well-being.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...rightmanforbloodline
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
Digital Health in India_Health Informatics Trained Manpower _DrDevTaneja_15.0...DrDevTaneja1
Digital India will need a big trained army of Health Informatics educated & trained manpower in India.
Presently, generalist IT manpower does most of the work in the healthcare industry in India. Academic Health Informatics education is not readily available at school & health university level or IT education institutions in India.
We look into the evolution of health informatics and its applications in the healthcare industry.
HIMMS TIGER resources are available to assist Health Informatics education.
Indian Health universities, IT Education institutions, and the healthcare industry must proactively collaborate to start health informatics courses on a big scale. An advocacy push from various stakeholders is also needed for this goal.
Health informatics has huge employment potential and provides a big business opportunity for the healthcare industry. A big pool of trained health informatics manpower can lead to product & service innovations on a global scale in India.
As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
1. ICH GCP (E6)GUIDELINES
Dr. SUMAN BAISHNAB
ICH GCP
Good Clinical Practices (GCP) is an international ethical &
scientific quality standard for designing, conducting,
recording & reporting trials that involve the participation of
human subjects
Compliance with this standard provides public assurance
that rights, safety & well being of trial subjects are
protected, consistent with the principles that have their
origin in the declaration of Helsinki, and that the clinical trial
data are credible
Objectives of ICH – GCP:
To provide a unified standard for the EU, Japan & the US to
facilitate the mutual acceptance of clinical data by regulatory
authorities in these jurisdictions
Should be followed when generating data that are intended
to be submitted to regulatory authorities.
ICH GCP…
Sections of ICH-E6 (GCP)
1. Glossary
2. Principles of GCP
3. EC/IRB Responsibilities
4. Investigator Responsibilities
5. Sponsor Responsibilities
6. Protocols and Amendments
7. Investigator’s Brochure
8. Essential Documents
Section 1- Glossary of various terms
Adverse drug reaction & Adverse Event
Case report form & Clinical Study Report
Coordinating Committee & Contract Research
Organization
Independent Ethics Committee & Institutional Review
Board
Investigator & Investigator’s Brochure
Monitoring & Monitoring report
Protocol & Protocol Amendment
Serious Adverse Event
Source data & Source documents
Sponsor & Sponsor investigator
Standard Operating Procedures
Vulnerable subjects
ICH GCP…
Section 2- Principles of GCP
Clinical Trials should be conducted in accordance with the
ethical principles consistent with GCP and applicable
regulatory requirements
Before a trial is initiated, foreseeable risks & inconveniences
should be weighed against anticipated benefit for the trial
subject & society
The rights, safety, and well being of the trial subjects are the
most important considerations & should prevail over
interests of science and society
The available nonclinical & clinical information on an
investigational product should adequately support the
proposed clinical trial
ICH GCP…
Section 2- Principles of GCP…
Clinical trials should be scientifically sound, & described in a
clear, detailed protocol; which has received prior IRB/IEC
approval
The medical care and medical decisions for subjects should
be the responsibility of a qualified physician
Each individual involved in conducting a trial should be
qualified by education, training & experience to perform his
respective task
Freely given informed consent should be obtained from
every subject prior to clinical trial participation
ICH GCP…
2. Section 2- Principles of GCP…
All clinical information should be recorded, handled, and
stored in a way that allows its accurate reporting,
interpretation and verification
The confidentiality of records that could identify patients
should be protected, respecting the privacy and
confidentiality rules in accordance with the applicable
regulatory requirements
Investigational products should be manufactured, handled
and stored in accordance with applicable GMP, and used in
accordance with the protocol
Systems with procedures that assure the quality of every
aspect of the trial should be implemented
ICH GCP…
Section 3- EC / IRB Responsibilities
Should safeguard the rights, safety & well being of all trial subjects
Review Protocol / Informed Consent Document / Recruitment
Procedures / Investigator’s Brochure / Remunerations
Ongoing Progress/Adverse events
IRB/IEC Composition
At least 5 members
At least one non scientific member
At least one independent member
Maintain list of members and qualifications
Only independent members to vote
Quorum to be present
ICH GCP…
IRB/IEC Documented Procedures
Composition
Meeting Scheduling & conduct
Specify that trial starts only after IRB review
Specify regarding changes in protocol
Specify prompt reporting of adverse events
All these documents should be made available for a period of
at least 3 years after completion of the trial and make them
available upon request from the regulatory authorities
The IRB/IEC may be asked by investigators, sponsors or
regulatory authorities to provide its written procedures and
membership lists
ICH GCP…
Informed Consent Document
The trial involves research
Purpose of the trial
Trial treatments & probability of random assignment to each
treatment
All trial procedures
Subject’s responsibility
Reasonably foreseeable risks or inconveniences to the
subject, embryo, infant
Reasonably expected benefits
Alternate course of treatment available
Compensation &/or treatment available for trial related
injury
ICH GCP…
Informed Consent Document…
Anticipated payment for participation
Anticipated expenses for participation
Participation is voluntary & subject may refuse or withdraw
any time during the trial without penalty or loss of benefits
Access to original medical records to auditor, monitor, IRB,
regulatory authorities
Subject identification would be confidential
Any new information that may affect willingness to
participate would be made available
Contact name, address in case of need
Foreseeable circumstances for trial termination
Expected duration of trial
Approximate number of subjects involved in the trial
ICH GCP…
Section 4- Investigator Responsibilities
Qualified (documented) by education, training & experience
to assume responsibility for proper trial conduct
Should be familiar with the appropriate use of the
investigational product, IB, and other information provided
by sponsor
Should be aware of, & should comply with, GCP and the
applicable regulatory requirements
Should permit monitoring, auditing and inspection
Delegation of duties to appropriately qualified persons
ICH GCP…
3. Section 4- Investigator Responsibilities…
Potential for recruitment of required number of subjects
Sufficient time for trial conduct and completion
Staff, facilities
Ensure training to staff
Qualified physician investigator/sub investigator for the
trial, should be responsible for all trial related medical
decisions
Adequate medical care during and after trail participation
Make reasonable efforts ascertaining for premature
withdrawal from trial
ICH GCP…
Section 4- Investigator Responsibilities…
Written & dated approval for trial protocol, ICD, recruitment
procedures etc. prior to trial initiation
Should provide latest copies of IB to IRB
Should provide all relevant documents for review during trial
Should conduct trial in accordance with the protocol version
agreed & documented by the sponsor, IRB and regulatory
authority
No changes allowed in the protocol except in case of
immediate hazard to the patient; which should be submitted
to all immediately
ICH GCP…
Section 4- Investigator Responsibilities…
Responsible for accountability at site
May be assigned to pharmacist/individual
Stored as specified by sponsor or regulatory authority
Used only in accordance with the protocol
Should follow the trial’s randomization procedure
Any premature unblinding to be explained to sponsor
Comply with regulatory requirement, GCP and ethical
principles
ICH GCP…
Section 4- Investigator Responsibilities…
Documented Communication of revised ICD to IRB and
patient
Subject or their legal representative should be fully informed
in their own language
Non technical language
Ample time for consent and opportunity for questions
Impartial witness for illiterate patients
Subject should receive a copy of the signed and dated ICD/
amendment
ICH GCP…
Section 4- Investigator Responsibilities…
Should ensure accuracy, completeness, legibility and
timeliness of data to sponsor in CRF
Correction in CRF should be signed, dated
Maintain trial related documents
Financial agreements in place
Access to records by monitor, regulatory agency or auditors
Progress reports to IRB
ICH GCP…
Section 4- Investigator Responsibilities…
Serious Adverse Events (SAE) should be reported
immediately to sponsor, and timely as required to
IRB/regulatory agency
Deaths reported as per requirement
SAE
Any untoward medical occurrence that at any dose:
Results in death
Is life threatening
Requires inpatient hospitalization or prolongation of
existing hospitalization
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect
ICH GCP…
4. Section 4- Investigator Responsibilities…
Should inform subjects
Should assure therapy and follow up
Should inform regulatory authorities
Should inform sponsor/IRB with explanation
Upon completion, should inform institution, IRB, and
regulatory authorities with a summary of the trial’s outcome
ICH GCP…
Section 5- Sponsor Responsibilities
An individual, company, institution, or organization which
takes responsibility for the initiation, management, and/or
financing of a clinical trial
Implementing & maintaining QA and QC systems with
written SOPs to ensure GCP compliance
Securing agreements from all sites for monitoring, auditing,
and inspections
QC of data handling
Payment agreements
ICH GCP…
Section 5- Sponsor Responsibilities…
CRO - A person or an organization (commercial, academic, or
other) contracted by the sponsor to perform one or more of a
sponsor’s trial related duties and functions
Sponsor may transfer all or some duties to CRO
Ultimate responsibility for quality lies with the sponsor
Document of all duty delegation required
ICH GCP…
Section 5- Sponsor Responsibilities…
Trial design
Trial management, data handling
Investigator selection
Financing
Submission to regulatory authorities
Confirmation of review by IRBs
Information on investigational product
Manufacturing, labeling, packaging & coding of product
Safety Evaluation
Monitoring
The act of overseeing the progress of a clinical trial, and of
ensuring that it is conducted, recorded, and reported in
accordance with the protocol, SOPs, GCP, and the applicable
regulatory requirements.
ICH GCP…
Section 6- Protocol and Amendments…
Document describing all aspects of the study
Well designed and thoroughly considered
Well structured
Complete
Components:
General Information
Objectives and Justification
Ethical considerations
Study design
Inclusion, Exclusions & withdrawal of subjects
Handling of products
ICH GCP…
Section 6- Protocol and Amendments…
Components:…
Assessment of Efficacy
Assessment of safety
Statistics
Data handling & management
Quality control & quality assurance
Finance and Insurance
Publication policy
Evaluation
Supplementaries & Appendices
ICH GCP…
5. Section 6- Protocol and Amendments…
General Information:
Protocol Title, identifying number & date. Amendment
number
Contact names, addresses
Name and title of Authorized signatory
Contact medical expert
Contact investigator(s)
Institution(s), Laboratories, department contact
ICH GCP…
Section 6- Protocol and Amendments…
Objective and Justification:
Aims & objectives, phase of study
Name & description of Investigational product
Summary of non clinical & clinical studies
Summary of risks & benefits
Description of route of administration, dosage
Statement of GCP compliance
Ethical Consideration:
Description of how patients/volunteers would be informed
ICH GCP…
Section 6- Protocol and Amendments…
Study Design:
Primary & secondary endpoints
Randomized/comparator/blinded/open, placebo controlled
Blinding technique(double blind/single blind)
Randomization(method & procedure)
Diagram of design, procedure & stages
Medications permitted & not permitted during study
Description of study treatments, dose, route during study
conduct
Packing/labeling description
Duration of subject participation & sequence of all study
periods, including follow up
ICH GCP…
Section 6- Protocol and Amendments…
Study Design:…
Proposed date of initiation of study
Discontinuation criteria for subjects
Instructions on suspending or terminating the study
Procedures for monitoring compliance
Inclusion Exclusion criteria:
Specifications of the subjects to be included (age, gender,
ethnic groups, prognostic factors, diagnostic criteria)
Specify exclusion criteria
Subject withdrawal criteria & procedures
ICH GCP…
Section 6- Protocol and Amendments…
Handling of Products:
Safe handling and storage measures
System to be followed for labeling
Labeling specifications
Efficacy assessment :
Specifications of efficacy parameters
Descriptions of how these are measured and recorded
Time & periodicity of recording
Description of special analysis/ tests(PK, clinical, lab,
radiology)
ICH GCP…
Section 6- Protocol and Amendments…
Safety assessment :
Specifications of safety parameters
Procedures for eliciting reports of and reporting ADR
Time & method of recording
Type, duration of follow up after adverse events
Statistics:
Description of statistical methods employed
Timing of interim analysis, if any
Significance level, power
Procedures for reporting any deviations from the original
statistical plan
Selection of subjects to be included in final analysis
ICH GCP…
6. Section 6- Protocol and Amendments…
Data Management :
Procedures for handling & processing records of effects and
adverse events
QC & QA:
Steps & procedures for monitoring study
Instructions for protocol deviations
Quality control of methods & evaluation procedures
Finance & insurance:
Budget, financial aspects
Sources of economic support
Subject payments
Reimbursement to team members
Insurance details of study subjects
ICH GCP…
Section 7- Investigator’s Brochure
Compilation of the clinical and nonclinical data on the
investigational product(s) that are relevant to the study of
the product(s) in human subjects
Provide the investigators and others involved in the trial
with the information to facilitate their understanding of the
rationale for, and their compliance with, many key features
of the protocol, such as the dose, dose frequency/interval,
methods of administration: and safety monitoring
procedures
ICH GCP…
Section 7- Investigator’s Brochure…
The IB also provides insight to support the clinical
management of the study subjects during the course of the
clinical trial
The information should be presented in a concise, simple,
objective, balanced, and non-promotional form that enables
a clinician, or potential investigator, to understand it and
make his/her own unbiased risk-benefit assessment of the
appropriateness of the proposed trial
Generally, the sponsor is responsible for ensuring that an up-
to-date IB is made available to the investigator(s) and the
investigators are responsible for providing the up-to-date IB
to the responsible IRBs/IECs
ICH GCP…
Section 7- Investigator’s Brochure…
The IB should include:
Title Page
Confidentiality Statement
Table of Contents
Summary of the investigational product
Introduction
Physical, Chemical, and Pharmaceutical Properties and
Formulation
Nonclinical Studies
Effects in Humans
Summary of Data and Guidance for the Investigator
ICH GCP…
Section 8- Essential Documents for the Conduct
of a Clinical Trial
Documents which individually and collectively permit
evaluation of the conduct of a trial and the quality of the
data produced
These documents serve to demonstrate the compliance of
the investigator, sponsor and monitor with the standards of
Good Clinical Practice and with all applicable regulatory
requirements
Various documents are grouped in three sections according
to the stage of the trial during which they will normally be
generated:
Before the clinical phase of the trial commences
During the clinical conduct of the trial
After completion or termination of the trial
ICH GCP…
Section 8- Essential Documents for the Conduct
of a Clinical Trial
Trial master files should be established at the beginning of
the trial, both at the investigator/institution’s site and at the
sponsor’s office
A final close-out of a trial can only be done when the monitor
has reviewed both investigator/institution and sponsor files
and confirmed that all necessary documents are in the
appropriate files
Any or all of the documents addressed in this guideline may
be subject to, and should be available for, audit by the
sponsor’s auditor and inspection by the regulatory
authorities
ICH GCP…