This document provides guidance on reporting serious adverse events (SAEs) that occur during clinical trials in India. It outlines the key stakeholders involved in SAE reporting, including the investigator, sponsor/CRO, ethics committee, and Drug Controller General of India (DCGI). The timelines and process for initial and follow-up SAE reporting are defined. Requirements for the documents to be submitted in SAE reports, such as the checklist, case report form pages, and discharge summary, are also reviewed to ensure completeness and accuracy of reporting. Common errors made in SAE documentation are highlighted.
This document provides guidance on reporting serious adverse events (SAEs) that occur during clinical trials in India. It outlines the key stakeholders involved in SAE reporting, including the investigator, sponsor/CRO, ethics committee, and Drug Controller General of India (DCGI). The timelines and process for initial and follow-up SAE reporting are defined. Requirements for the documents to be submitted in SAE reports, such as the checklist, case report form pages, and discharge summary, are also reviewed to ensure completeness and accuracy of the reports. Common errors made in SAE documentation are highlighted.
Adverse Events and Serious Adverse Events - Katalyst HLSKatalyst HLS
This document discusses adverse events and serious adverse events in clinical trials. It reviews FDA inspection findings related to reporting adverse events and the regulations surrounding adverse event reporting. It outlines how adverse events should be recorded, including source documentation and attribution. It also discusses reporting criteria and timelines for reporting adverse events to sponsors and regulatory bodies. Finally, it reviews considerations for auditing adverse events, such as whether events were properly graded and reported.
The document discusses adverse event and serious adverse event reporting in clinical trials. It provides definitions for key terms like adverse event, serious adverse event, and unexpected adverse reaction. It outlines ICH-GCP guidelines for safety reporting, including immediate reporting of SAEs to sponsors. Finally, it presents a case study describing a subject's experience of accelerated hypertension as an SAE during a clinical trial and the appropriate reporting steps taken.
This document discusses audits and inspections in clinical trials. It defines an audit as a systematic examination of trial activities and documents to determine compliance, while an inspection involves a regulatory review of documents, facilities, and resources related to a trial. The key differences between audits and inspections are that audits are conducted internally by sponsors or CROs, while inspections are done by regulatory authorities. Routine audits ensure compliance, while for-cause audits investigate non-compliance issues. Audits and inspections evaluate areas like personnel, trial conduct, documentation, drug accountability, and computer systems. Proper preparation and responding to document requests within time limits are important for audits and inspections.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
Clinical research involves systematic studies on humans to test new drugs, devices, or procedures for safety and effectiveness. The document outlines the various phases of clinical research and drug development process. It describes the roles and responsibilities of key players on a research team including the principal investigator, clinical research coordinator, clinical research associate, and others. It also discusses ethical principles in clinical research and important considerations like informed consent and safety monitoring.
This document provides guidance on reporting serious adverse events (SAEs) that occur during clinical trials in India. It outlines the key stakeholders involved in SAE reporting, including the investigator, sponsor/CRO, ethics committee, and Drug Controller General of India (DCGI). The timelines and process for initial and follow-up SAE reporting are defined. Requirements for the documents to be submitted in SAE reports, such as the checklist, case report form pages, and discharge summary, are also reviewed to ensure completeness and accuracy of the reports. Common errors made in SAE documentation are highlighted.
Adverse Events and Serious Adverse Events - Katalyst HLSKatalyst HLS
This document discusses adverse events and serious adverse events in clinical trials. It reviews FDA inspection findings related to reporting adverse events and the regulations surrounding adverse event reporting. It outlines how adverse events should be recorded, including source documentation and attribution. It also discusses reporting criteria and timelines for reporting adverse events to sponsors and regulatory bodies. Finally, it reviews considerations for auditing adverse events, such as whether events were properly graded and reported.
The document discusses adverse event and serious adverse event reporting in clinical trials. It provides definitions for key terms like adverse event, serious adverse event, and unexpected adverse reaction. It outlines ICH-GCP guidelines for safety reporting, including immediate reporting of SAEs to sponsors. Finally, it presents a case study describing a subject's experience of accelerated hypertension as an SAE during a clinical trial and the appropriate reporting steps taken.
This document discusses audits and inspections in clinical trials. It defines an audit as a systematic examination of trial activities and documents to determine compliance, while an inspection involves a regulatory review of documents, facilities, and resources related to a trial. The key differences between audits and inspections are that audits are conducted internally by sponsors or CROs, while inspections are done by regulatory authorities. Routine audits ensure compliance, while for-cause audits investigate non-compliance issues. Audits and inspections evaluate areas like personnel, trial conduct, documentation, drug accountability, and computer systems. Proper preparation and responding to document requests within time limits are important for audits and inspections.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
Clinical research involves systematic studies on humans to test new drugs, devices, or procedures for safety and effectiveness. The document outlines the various phases of clinical research and drug development process. It describes the roles and responsibilities of key players on a research team including the principal investigator, clinical research coordinator, clinical research associate, and others. It also discusses ethical principles in clinical research and important considerations like informed consent and safety monitoring.
A Trial Master File (TMF) is set up at the beginning of the trial. It is a collection of all essential documents pertaining to the trial, which in turn will allow for effective monitoring and supervision (audit). In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential.
According to the GCP guidelines, it is the responsibility of the sponsor to ensure that the TMF includes all relevant essential documents, and is stored in a secure location, with restricted access. Generally, the TMF is maintained at the sponsor’s office, co-ordinating site or by the Contract Research Organisation (CRO), if contracted. In addition to the TMF, copies of all relevant documents must be kept at each participating site, in an Investigator Site File (ISF). The ISF will also include all site-specific essential documents. For example, site preparedness log or site visit logs, etc.
A member of the research or trial team should be delegated with the task of updating, maintaining and reviewing the TMF and ISF, periodically throughout the course of the clinical trial as per the defined SOPs. Ideally, the documents included in the TMF are:
Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
Training documentation for the trial team
Details of the laboratories, if applicable.
Contracts, agreements, budgets, etc.
Monitoring visit reports (for each site visit onsite or central)
Documents related to the safety reporting
Ethics Committees documents (composition of the EC, approvals, notifications, reports, etc.)
Site-specific documents (list of site staff and their curriculum vitae, investigator’s undertaking, site preparedness documents, training of site staff, etc.)
Audit related documents, if available (if an audit was conducted).
Significant communications
Others
The GCP guidelines provide comprehensive guidance regarding the documents to be included in a Trial Master File categorised according to the lifecycle of the trial. This information can also be accessed here.
It shall be the responsibility of the sponsor to make arrangements for the safe and secure custody of all study-related documents and material for a period of three years after the completion of the study or submission of the data to the regulatory authority(ies) whichever is later.
Investigator Site File (ISF) / Trial Master file in trial (TMF)KiranRajput38
This document discusses the investigator site file (ISF) for a Phase 3 clinical trial of COVAXINE, a COVID-19 vaccine. It notes that the principal investigator is responsible for creating and maintaining the ISF. The contents of the ISF include essential documents like the protocol, informed consent forms, and case report forms. The document outlines procedures for maintaining the ISF, including updating it ongoing, filing documents without delay, and replacing outdated versions of documents. It also discusses who is responsible for single site studies and maintaining organization and version control of important documents in the ISF.
The document discusses factors to consider when selecting clinical trial sites and investigators. Key criteria for site selection include the experience and qualifications of staff, availability of suitable patients, and ability to perform required assessments. Important considerations for investigator selection are their education, training, experience recruiting patients, and ability to properly conduct the trial within the required timelines. The selection process involves sponsors asking CROs to evaluate potential sites and investigators through feasibility interviews and assessments of qualifications.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
The document defines key terms related to clinical trial monitoring such as monitoring, monitoring visits, and monitoring reports. It describes the purpose of monitoring is to protect subjects, ensure accurate data, and ensure compliance. It discusses selecting qualified monitors and different types of monitoring visits including site evaluation, initiation, routine monitoring, and close-out visits. The key responsibilities of monitors during visits are also summarized.
The document outlines new rules for drugs and clinical trials in India established by the Ministry of Health and Family Welfare in 2019. Key aspects include:
- Establishing authorities like the Central Licensing Authority to oversee drug approval and clinical trials.
- Requiring Ethics Committee approval and registration for clinical trials and bioavailability/bioequivalence studies.
- Detailing processes for approval and oversight of clinical trials, including applications, inspections, and suspending trials.
- Establishing compensation amounts in cases of injury or death in clinical trials based on risk factors and disability percentages.
This document outlines the steps for conducting a clinical trial and conducting a site qualification visit. It discusses preparing essential documents, selecting an investigator and site, conducting the qualification visit to assess the site's capabilities, and reviewing requirements like the protocol, informed consent, reporting procedures, documentation, facilities, staff experience, and regulatory approvals. The qualification visit confirms the site's readiness before initiating a clinical trial.
The clinical research associate (CRA), also known as the monitor, acts as the main line of communication between the sponsor and investigator. The CRA is responsible for evaluating investigators to ensure they are qualified through training and experience and have adequate resources to properly conduct the trial. Additional responsibilities include conducting pre-study visits to assess investigator experience and facilities, site initiation visits to detail study obligations, and routine monitoring visits to ensure subjects' rights and data accuracy and compliance with regulations. The CRA also performs site closeout visits when enrollment and subjects' activities are complete and data are finalized.
The CRA oversees all stages of clinical trials from site selection to completion. They identify investigators, set up trial sites, train staff, monitor compliance, and verify informed consent and data collection. The CRA ensures protocols are followed, documents are collected, and supplies are accounted for throughout the trial. Effective communication, relationship building, attention to detail, and strong organizational skills are important for this role.
Understanding Contracts in the Clinical Research ProcessMichael Swit
Presentation on key aspects of clinical trial agreements, with an emphasis on clauses impacting indemnification, confidentiality, material transfers, record retention, ownership of data,
The document discusses investigational product (IMP) management at clinical trial sites. It provides guidance on proper IMP storage, dispensing, accountability, and documentation. The key points are:
1) IMP must be stored according to good manufacturing practices and protocol specifications, with temperature monitoring and documentation.
2) Sites must have procedures for IMP receipt, dispensing only to enrolled subjects, compliance monitoring, and documentation of use and returns in inventory and source records.
3) Sponsors are responsible for IMP supply and ensuring proper site procedures through monitoring and documentation of IMP accountability.
Essential Documents For the Conduct of Clinical TrialClinosolIndia
This document outlines essential documents that should be generated and maintained before, during, and after a clinical trial. It lists key documents such as the investigator brochure, signed protocol and consent forms, financial agreements, IRB approval, investigator qualifications, safety reporting procedures, and monitoring visit reports. Maintaining these documents allows evaluation of trial conduct and data quality. The documents are to be located in both investigator and sponsor files, with some only requiring location in one file. Proper documentation helps ensure compliance with regulations and good clinical practice standards.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
Clinical Data Management Plan_Katalyst HLSKatalyst HLS
A data management plan (DMP) ensures consistent and effective clinical data management practices throughout a clinical trial. The DMP describes all data management activities, roles, and responsibilities to promote standardized data handling. It provides an agreement between parties on data management deliverables. The DMP covers components like data flow, capture, setup, entry, transfer, processing, coding, safety handling, external data, and database locking. It serves to plan, communicate, and reference data management tasks. Developing a thorough DMP helps ensure quality and regulatory compliance in data collection and analysis.
This document outlines procedures for reporting and managing serious adverse events (SAEs) related to research. It defines an SAE as an untoward medical occurrence that may not be causally related to the research. Investigators are responsible for reporting SAEs using a study-specific form within a specified timeframe. The chief investigator then reviews the SAE for seriousness, causality, and expectedness. For related or unexpected SAEs, the trial manager submits reports to the approving research ethics committee. The trial management group may provide consensus on SAE classifications as needed. The document provides detailed guidance on procedures for classifying, documenting, reporting and following up on SAEs.
A Clinical Research Coordinator (CRC) is a healthcare professional who plays a crucial role in the execution and management of clinical research studies. The CRC acts as a liaison between the study sponsor, principal investigator (PI), study participants, and other members of the research team. Their primary responsibility is to ensure the smooth conduct of clinical trials and adherence to protocol requirements. Here are some key responsibilities of a Clinical Research Coordinator
The document discusses case report forms (CRFs), which are used in clinical trials to record patient data. It defines CRFs and explains that they contain all protocol-required information including adverse events. The goals of CRFs are to collect verifiable data according to Good Clinical Practice standards. CRFs can be paper-based or electronic. Well-designed CRFs are structured and formatted consistently to facilitate accurate data collection while avoiding duplication. CRFs provide essential standardized data that is analyzed to advance medical research.
The document provides guidance on reporting unanticipated problems involving risks to subjects or others (UPIRTSO) and protocol deviations according to the policies of IUPUI's Institutional Review Board (IRB). It explains what types of events require prompt reporting using the UPIRTSO form within 10 or 30 days and what information should be included. Events not meeting the UPIRTSO criteria can be reported at continuing review. The document emphasizes following these policies carefully to avoid risks to subjects and ensure compliance.
Life insurance is a contract between you and the life insurance company (the insurer), which provides you (the assured) or your beneficiary for whose benefit the policy is taken with a pre-determined amount on the happening of a particular event contingent on the duration of human life
A Trial Master File (TMF) is set up at the beginning of the trial. It is a collection of all essential documents pertaining to the trial, which in turn will allow for effective monitoring and supervision (audit). In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential.
According to the GCP guidelines, it is the responsibility of the sponsor to ensure that the TMF includes all relevant essential documents, and is stored in a secure location, with restricted access. Generally, the TMF is maintained at the sponsor’s office, co-ordinating site or by the Contract Research Organisation (CRO), if contracted. In addition to the TMF, copies of all relevant documents must be kept at each participating site, in an Investigator Site File (ISF). The ISF will also include all site-specific essential documents. For example, site preparedness log or site visit logs, etc.
A member of the research or trial team should be delegated with the task of updating, maintaining and reviewing the TMF and ISF, periodically throughout the course of the clinical trial as per the defined SOPs. Ideally, the documents included in the TMF are:
Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
Training documentation for the trial team
Details of the laboratories, if applicable.
Contracts, agreements, budgets, etc.
Monitoring visit reports (for each site visit onsite or central)
Documents related to the safety reporting
Ethics Committees documents (composition of the EC, approvals, notifications, reports, etc.)
Site-specific documents (list of site staff and their curriculum vitae, investigator’s undertaking, site preparedness documents, training of site staff, etc.)
Audit related documents, if available (if an audit was conducted).
Significant communications
Others
The GCP guidelines provide comprehensive guidance regarding the documents to be included in a Trial Master File categorised according to the lifecycle of the trial. This information can also be accessed here.
It shall be the responsibility of the sponsor to make arrangements for the safe and secure custody of all study-related documents and material for a period of three years after the completion of the study or submission of the data to the regulatory authority(ies) whichever is later.
Investigator Site File (ISF) / Trial Master file in trial (TMF)KiranRajput38
This document discusses the investigator site file (ISF) for a Phase 3 clinical trial of COVAXINE, a COVID-19 vaccine. It notes that the principal investigator is responsible for creating and maintaining the ISF. The contents of the ISF include essential documents like the protocol, informed consent forms, and case report forms. The document outlines procedures for maintaining the ISF, including updating it ongoing, filing documents without delay, and replacing outdated versions of documents. It also discusses who is responsible for single site studies and maintaining organization and version control of important documents in the ISF.
The document discusses factors to consider when selecting clinical trial sites and investigators. Key criteria for site selection include the experience and qualifications of staff, availability of suitable patients, and ability to perform required assessments. Important considerations for investigator selection are their education, training, experience recruiting patients, and ability to properly conduct the trial within the required timelines. The selection process involves sponsors asking CROs to evaluate potential sites and investigators through feasibility interviews and assessments of qualifications.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
The document defines key terms related to clinical trial monitoring such as monitoring, monitoring visits, and monitoring reports. It describes the purpose of monitoring is to protect subjects, ensure accurate data, and ensure compliance. It discusses selecting qualified monitors and different types of monitoring visits including site evaluation, initiation, routine monitoring, and close-out visits. The key responsibilities of monitors during visits are also summarized.
The document outlines new rules for drugs and clinical trials in India established by the Ministry of Health and Family Welfare in 2019. Key aspects include:
- Establishing authorities like the Central Licensing Authority to oversee drug approval and clinical trials.
- Requiring Ethics Committee approval and registration for clinical trials and bioavailability/bioequivalence studies.
- Detailing processes for approval and oversight of clinical trials, including applications, inspections, and suspending trials.
- Establishing compensation amounts in cases of injury or death in clinical trials based on risk factors and disability percentages.
This document outlines the steps for conducting a clinical trial and conducting a site qualification visit. It discusses preparing essential documents, selecting an investigator and site, conducting the qualification visit to assess the site's capabilities, and reviewing requirements like the protocol, informed consent, reporting procedures, documentation, facilities, staff experience, and regulatory approvals. The qualification visit confirms the site's readiness before initiating a clinical trial.
The clinical research associate (CRA), also known as the monitor, acts as the main line of communication between the sponsor and investigator. The CRA is responsible for evaluating investigators to ensure they are qualified through training and experience and have adequate resources to properly conduct the trial. Additional responsibilities include conducting pre-study visits to assess investigator experience and facilities, site initiation visits to detail study obligations, and routine monitoring visits to ensure subjects' rights and data accuracy and compliance with regulations. The CRA also performs site closeout visits when enrollment and subjects' activities are complete and data are finalized.
The CRA oversees all stages of clinical trials from site selection to completion. They identify investigators, set up trial sites, train staff, monitor compliance, and verify informed consent and data collection. The CRA ensures protocols are followed, documents are collected, and supplies are accounted for throughout the trial. Effective communication, relationship building, attention to detail, and strong organizational skills are important for this role.
Understanding Contracts in the Clinical Research ProcessMichael Swit
Presentation on key aspects of clinical trial agreements, with an emphasis on clauses impacting indemnification, confidentiality, material transfers, record retention, ownership of data,
The document discusses investigational product (IMP) management at clinical trial sites. It provides guidance on proper IMP storage, dispensing, accountability, and documentation. The key points are:
1) IMP must be stored according to good manufacturing practices and protocol specifications, with temperature monitoring and documentation.
2) Sites must have procedures for IMP receipt, dispensing only to enrolled subjects, compliance monitoring, and documentation of use and returns in inventory and source records.
3) Sponsors are responsible for IMP supply and ensuring proper site procedures through monitoring and documentation of IMP accountability.
Essential Documents For the Conduct of Clinical TrialClinosolIndia
This document outlines essential documents that should be generated and maintained before, during, and after a clinical trial. It lists key documents such as the investigator brochure, signed protocol and consent forms, financial agreements, IRB approval, investigator qualifications, safety reporting procedures, and monitoring visit reports. Maintaining these documents allows evaluation of trial conduct and data quality. The documents are to be located in both investigator and sponsor files, with some only requiring location in one file. Proper documentation helps ensure compliance with regulations and good clinical practice standards.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
Clinical Data Management Plan_Katalyst HLSKatalyst HLS
A data management plan (DMP) ensures consistent and effective clinical data management practices throughout a clinical trial. The DMP describes all data management activities, roles, and responsibilities to promote standardized data handling. It provides an agreement between parties on data management deliverables. The DMP covers components like data flow, capture, setup, entry, transfer, processing, coding, safety handling, external data, and database locking. It serves to plan, communicate, and reference data management tasks. Developing a thorough DMP helps ensure quality and regulatory compliance in data collection and analysis.
This document outlines procedures for reporting and managing serious adverse events (SAEs) related to research. It defines an SAE as an untoward medical occurrence that may not be causally related to the research. Investigators are responsible for reporting SAEs using a study-specific form within a specified timeframe. The chief investigator then reviews the SAE for seriousness, causality, and expectedness. For related or unexpected SAEs, the trial manager submits reports to the approving research ethics committee. The trial management group may provide consensus on SAE classifications as needed. The document provides detailed guidance on procedures for classifying, documenting, reporting and following up on SAEs.
A Clinical Research Coordinator (CRC) is a healthcare professional who plays a crucial role in the execution and management of clinical research studies. The CRC acts as a liaison between the study sponsor, principal investigator (PI), study participants, and other members of the research team. Their primary responsibility is to ensure the smooth conduct of clinical trials and adherence to protocol requirements. Here are some key responsibilities of a Clinical Research Coordinator
The document discusses case report forms (CRFs), which are used in clinical trials to record patient data. It defines CRFs and explains that they contain all protocol-required information including adverse events. The goals of CRFs are to collect verifiable data according to Good Clinical Practice standards. CRFs can be paper-based or electronic. Well-designed CRFs are structured and formatted consistently to facilitate accurate data collection while avoiding duplication. CRFs provide essential standardized data that is analyzed to advance medical research.
The document provides guidance on reporting unanticipated problems involving risks to subjects or others (UPIRTSO) and protocol deviations according to the policies of IUPUI's Institutional Review Board (IRB). It explains what types of events require prompt reporting using the UPIRTSO form within 10 or 30 days and what information should be included. Events not meeting the UPIRTSO criteria can be reported at continuing review. The document emphasizes following these policies carefully to avoid risks to subjects and ensure compliance.
Life insurance is a contract between you and the life insurance company (the insurer), which provides you (the assured) or your beneficiary for whose benefit the policy is taken with a pre-determined amount on the happening of a particular event contingent on the duration of human life
Health plus claim intimation form is for Health Insurance Policies (HCB & MSB Claims).Form must be completed & signed by Policy Holder / Principal Insured only and submitted to the TPA.
1. This document appears to be a bill submitted by Tie-up Hospital to ESIC (Employee State Insurance Corporation) for reimbursement for medical services provided.
2. It includes details of a cataract surgery performed on a patient named Vallavan R., including diagnosis, treatment provided, costs claimed, and certifications that cashless treatment was provided according to the agreement between the hospital and ESIC.
3. The total amount claimed is Rs. 15,175 and various forms are included as required documentation for the bill to be processed by ESIC, such as discharge records, referral documents, and patient satisfaction certification.
The document provides information and forms related to registration for new postgraduate students at the Institute of Postgraduate Studies. It includes:
1. Steps and checklists for registration for research mode and coursework/mixed mode students.
2. Medical examination report forms for international students and accompanying persons for immigration purposes.
3. Various registration forms including confirmation of registration, change of address, and smart card application.
4. Contact details for important offices are also listed.
This document provides guidance on properly completing a Plan of Care (POC) or 485 form. It reviews the purpose and contents of each section or "locator box" of the form. Key points include properly documenting patient information, diagnoses, orders, goals and ensuring the form is updated at recertification. Audit trends that are commonly found like missing dates or diagnoses not matching medications are also highlighted to improve documentation quality.
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.
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.
Pre- Authorization form is to be filled in case of hospitalization. It is basically a declaration by the patient to make claim for the expenses incurred during the hospitalization. While seeking health insurance coverage under Optima Restore, the Pre- Authorization form must be filled to avail the policy support. Through this Apollo Munich seek information about the patient or the insured person like name of the patient, contact details, age, policy number and card ID number, name of the hospital, nature of illness and other related details. All columns must be closely examined to provide genuine information to the insurer. The form must be duly filled and then must be attached with all the necessary documents absence of which can lead to complication.
Aridis Pharmaceuticals Inc is a late-stage biopharmaceutical company. It is engaged in the discovery and development of targeted immunotherapy using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections.
Aridis Pharmaceuticals Inc is a late-stage biopharmaceutical company. It is engaged in the discovery and development of targeted immunotherapy using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections.
Regulatory Challenges to Successful Global Clinical StudiesMichael Swit
A review of key issues that can make or break the success of a clinical study conducted outside the United States, with an emphasis on site, GCP issues, challenges that vary nationally, and enforcement concerns.
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.
Informed consent documents are required to explain clinical trials to participants and obtain their signed agreement to participate. They must include the study purpose, procedures, risks/benefits, alternatives to participation, and participant rights. Case report forms are used to record all required study data for each participant and facilitate data collection, management, and analysis while protecting privacy. The investigator's brochure provides investigators details on the investigational product and guidance for the study based on nonclinical and clinical data.
This document discusses clinical trial safety and pharmacovigilance responsibilities in Europe. It outlines legislation and definitions for adverse events, serious adverse reactions, and unexpected serious adverse reactions. It describes investigator responsibilities to notify sponsors of suspected unexpected serious adverse reactions within 24 hours. It also outlines sponsor responsibilities to report fatal or life-threatening unexpected serious adverse reactions to competent authorities and ethics committees within 7 days. Finally, it discusses periodic safety reporting requirements including annual safety reports and periodic safety update reports required for marketed products.
This document is a questionnaire for liability insurance for a single clinical trial. It requests information about the named insured, study details like the protocol number and title, trial period, number of subjects, hospital locations, and documents like the protocol, patient information, and consent forms. It is collecting details on the clinical trial to provide liability insurance for that specific study.
Discrediting the Consultative Social Security Exam Before During and After th...socialsecurityneil
How to discredit the consultative social security exam before, during and after the exam. Discredit the exam when it is: inaccurate; allows for bias of the examiner; where the claimant has difficulty getting to the exam; it costs the government money; it hurts the claimant; it scares the claimant.
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This is part 1 of my Java Learning Journey. This Contains Custom methods, classes, constructors, packages, multithreading , try- catch block, finally block and more.
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ISO/IEC 27001, ISO/IEC 42001, and GDPR: Best Practices for Implementation and...PECB
Denis is a dynamic and results-driven Chief Information Officer (CIO) with a distinguished career spanning information systems analysis and technical project management. With a proven track record of spearheading the design and delivery of cutting-edge Information Management solutions, he has consistently elevated business operations, streamlined reporting functions, and maximized process efficiency.
Certified as an ISO/IEC 27001: Information Security Management Systems (ISMS) Lead Implementer, Data Protection Officer, and Cyber Risks Analyst, Denis brings a heightened focus on data security, privacy, and cyber resilience to every endeavor.
His expertise extends across a diverse spectrum of reporting, database, and web development applications, underpinned by an exceptional grasp of data storage and virtualization technologies. His proficiency in application testing, database administration, and data cleansing ensures seamless execution of complex projects.
What sets Denis apart is his comprehensive understanding of Business and Systems Analysis technologies, honed through involvement in all phases of the Software Development Lifecycle (SDLC). From meticulous requirements gathering to precise analysis, innovative design, rigorous development, thorough testing, and successful implementation, he has consistently delivered exceptional results.
Throughout his career, he has taken on multifaceted roles, from leading technical project management teams to owning solutions that drive operational excellence. His conscientious and proactive approach is unwavering, whether he is working independently or collaboratively within a team. His ability to connect with colleagues on a personal level underscores his commitment to fostering a harmonious and productive workplace environment.
Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
Let’s explore the intersection of technology and equity in the final session of our DEI series. Discover how AI tools, like ChatGPT, can be used to support and enhance your nonprofit's DEI initiatives. Participants will gain insights into practical AI applications and get tips for leveraging technology to advance their DEI goals.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
How to Fix the Import Error in the Odoo 17Celine George
An import error occurs when a program fails to import a module or library, disrupting its execution. In languages like Python, this issue arises when the specified module cannot be found or accessed, hindering the program's functionality. Resolving import errors is crucial for maintaining smooth software operation and uninterrupted development processes.
2. OBJECTIVES
SAE reporting timelines
Familiarizing with the Checklist
Documents to be submitted
Adequacy of the documents
Responsibilities of the stake holders
2
3. Serious Adverse Event : Definition
An SAE or SAR is any untoward medical occurrence
that:
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
Is of medical importance
3
5. SAE Occurrence
Initial
Report
Within 24 hours
of SAE occurrence
Investigator
DCGI
Chairman EC
Sponsor/CRO
Within 10 Calendar
Days of SAE
occurrence
Analyzed
Report
Head of
Institution
Chairman of EC
DCGI
Within 21 Calendar
Days of SAE
occurrence
Analyzed Report
& Compensation
recommendation
DCGI
Within 30 days of
Receiving report
From EC
Recommendation
on Compensation
Sponsor/CRO
Patient/Relative
Within 3 months of
Receipt of SAE
report
Order for
Compensation
Within 30 days of
Order of receipt
Final Compensation
to be paid
Chairman of Expert
Committee (DCGI)
Chairman of Expert
Committee (DCGI)
In case of Death
5
6. SAE Reporting Requirement
Time lines..
The timelines discussed is the maximum time limit to send the
information but the information should be send as early as
possible
Clear and unequivocal information should be provided in the
SAE report.
Keep adequate margins in the Left hand side
The documents printed on both sides of a page, can be
submitted. However, one should take care that the information
is not obscured when the page is placed in a binder.
6
7. Reporting of SAEs
PI/Designee will report the SAE to (in the SAE form)
• DCGI dci@nic.in
• Sponsor
• EC chairman
Please note to use the site letter head wherever required
7
8. How to report? … completing the
Index page
8
• Include a cover page
with every report
(Initial/follow ups).
• Please ensure that all
listed documents are
enclosed
• The SSE to assist the
Investigator to prepare
the SAE reports for
Submission to
CDSCO as per
Appendix XI of
Schedule-Y
• The set of documents
as per the checklist to
be arranged with
proper indexing and
page number
INDEX
Sl No Details Page No:
1 Checklist for submission of Serious Adverse Events
Report (SAE) occurring in Clinical Trials
1-2
2 Covering letter to DCGI 3-4
3 Filled Appendix XI 5-8
4 Lab reports/Discharge summary/Autopsy report 9-17
5 Additional Information 17-19
6 EC notification of SAE (initial/follow up) with
acknowledgement from the EC
20-21
7 DCGI approval letter /NOC 22-26
8 Blinded copy of signed ICF in patient’s native language 27-42
9 Blank copy of English ICF 43-63
10 Copy of eCRF pages 64-71
9. 1. Completed Checklist page 1
9
All items mentioned in the checklist may not be applicable for all SAEs. The items not relevant to a
particular SAE should be marked “Not Applicable (NA)”.
11. 2. Covering letter to the DCGI
On the letter head of the PI/Institution
Date:
The Drug Controller General of India,
Directorate General of Health Services,
Ministry of Health & Family Welfare,
FDA Bhawan, ITO, Kotla Road,
Delhi – 110 002
Sub: Initial information of the Serious Adverse Event reported for a subject
participating in the trial mentioned
Ref: Trial ID: Protocol Name
Respected Sir,
With respect to the above mentioned study please find enclosed the documents related to
the SAE reported at <Name of the Hospital>. Please be informed that the above information
has been notified to the Sponsor, Institutional Ethic Committee and Head of the Institution
on <date>
Please find below the brief information of the event
Adverse Event
term
Date of Onset Subject No Relationship to the
Investigational
Product
Outcome
I request you to review the documents and provide the acknowledgement. In case you require
any further information please contact the undersigned
Thank you
Yours truly
Name of the PI/Designated person
Attachments:
As per the checklist
11
12. ADEQUACY IN COMPLETING
THE DOCUMENTS
3. Appendix XI
Check for the completeness and correctness
SAE form should be filled only from the source
Review Source, eCRF entry & Protocol before completion
Subject Details
Suspected Drug
Concomitant Drug History
Details of the Event
Outcome
Signed and Dated by the Investigator
12
13. Narrating the Event
Full description of the event (s)
Body site
Severity,
criterion (or criteria ) for regarding the report as serious.
description of the reported signs and symptoms,
Describe a specific diagnosis for the reaction
Event term may change during the follow up period
Outcome: Follow up till resolution.
All follow up reports to be notified to EC & Sponsor
13
14. Causality Assessment
SSE to provide all documents to the PI to make the
right assessment with reasoning for
Related/Unrelated/Possible/Probable .
Source notes before/during/after the Event
Relevant documents from other hospital (if
applicable).
14
15. Analysis of SAE
The analyzed report should contain following information:
Diagnosis/ConMed information if any.
Whether the SAE was severe/moderate/mild
SAE falls under which criteria of seriousness as per SAE
definition
Whether the adverse events was serious and suspected or serious
and unexpected
Causality assessment i.e. related to the study drug or not
What action was taken with the study drug i.e. continued or
discontinued or interrupted for certain duration
Whether the dose of the study drug was increased or decreased or
continued as previous dose
Outcome of SAE i.e. resolved/not resolved/resolved with sequelae
If SAE related to death/if Autopsy is performed -detailed Autopsy
report. 15
16. Common Errors Observed..
Date of Birth discrepancy in the discharge summary/lab
report/Autopsy report etc.
Units not mentioned for Height, Weight etc
Writing the signs & Symptoms instead of mentioning the Event
name (e.g. abdominal pain instead of appendicitis)
If the severity of the baseline illness/lab abnormality later
developed into an SAE, mismatch noticed in the start and stop
dates of AE & SAE
Subject’s confidential information are not masked in the lab
report/discharge summary etc
Discrepancy in the start date/stop date entry of Concomitant
medication and AE/SAE start/stop date
Date and signature of the delegated person not present in the Lab
reports
Resolve the queries with adequate explanation, to avoid re-queries
16
17. Adequacy of Documents contd..
4. Lab reports/Discharge summary
Include lab reports showing baseline values of Investigations prior to
administration of IP & during the time of SAE (as required)
Mask the subject identifiers (name, MRD/OP/IP no:, address etc)
Ensure that PI/Sub I has reviewed the reports by confirming the date
and signature
5. Additional Information
Protocol Title/Study No/Code
CTRI Registration No
Sponsor/CRO details
Details about the Ethics Committee
Site No:, Site Address
Socio economic background of the subject viz qualification,
Occupation, monthly income
17
18. Additional InformationAdditional information for Serious Adverse Event (SAE) reported for <protocol name>
1. Protocol Title:
2. Protocol study No./ID/Code:
3. Copy of clinical Trail Permission obtained from CDSCO:
Attached
4. CTRI Registration No: CTRI/2014/xx/xxxxxx
5. Sponsor (Address with contact no and Email):
Address
Telephone No Fax: Email:
6. CRO (Address with contact no and Email:
Address
Telephone No Fax: Email:
7. Initial/Follow-up (FU):
8. In case of follow-up: Date & Diary no of initial or recently submitted report information:
9. Details about the Ethics committee:
Name & Address:
Name of Chairman & Address:
Telephone/Mobile Number: Email:
10. Site No:
11. Socioeconomic Background of the subject:
18
19. 6. EC Notification
Date:
To,
The Chairperson
Institutional Ethics Committee
Trial ID:
Protocol Title:
Subject: Initial/FUP information on serious adverse event reported for the <subject>on above
mentioned clinical study.
Dear sir/Madam,
The Institutional Ethics Committee has approved the referenced study in the meeting held on
<date> . We would like to inform you one SAE occurred at our site for the following subject.
Sl.No Adverse Event Term Date of Onset Subject no Relationship to
the trial drug as
per the
Investigator
Outcome
Please find the attached Appendix XI for the complete details of the event.
In case of any additional information required in this regard, please do contact undersigned.
Thanking you,
Yours faithfully,
Name & Address of the PI
Attachments: Copy of Appendix XI
Acknowledged By
Role in the EC ____________ Date:
19
SSE to ensure the
initial reporting has
happened within 24
hours of
occurrence of the
event.
Confirm the date of
submission and
date of
acknowledgement
mentioned in the
Notification letter
20. Documents Required..
7. DCGI Approval Letter
8.Signed ICF
Mask the subject identifiers except signatures (name, address,
name of the nominee address etc.)
9. English version of the ICF to be enclosed in case local
language ICF is used
10. eCRF pages
Relevant eCRF pages where the details of the SAE are
captured
20
21. SAE Reporting by Sponsor/CRO
Upon receiving initial SAE report from Investigator,
Sponsor will perform analysis in consultation with PI
Sponsor/ CRO will transform this information in
CIOMS Form and will submit this analyzed report
within 10 calendar days to DCGI, Chairman of EC and
Head of Institution where study is being conducted.
21
22. SAE Reporting by Ethics
Committee
The reports of SAEs of deaths should be prepared and
submitted in Red Cover.
The reports of SAE of injury other than deaths should be
prepared and submitted in Blue Cover
The SAE report other than death or injury is to be prepared
and submitted in White Cover. cover
22
Text and tables should be prepared using margins that allow the document to be printed clearly without losing any information and the left-hand margin should be sufficiently large so that information is not obscured by the method of binding.
Take the photocopy of the original ICF and mask the confidential information