Preclinical studies are performed using in vitro, in vivo, ex vivo, and in silico models to obtain basic safety and efficacy information on drug candidates before human testing. The data from preclinical trials must be accurate, reliable, and based on suitable models comparable to the target population. This data is submitted to regulatory agencies like the FDA/EMA along with the Investigational New Drug (IND) application to get approval to begin clinical trials. Clinical trials are then conducted in four phases to continue evaluating safety and efficacy in humans.
This document summarizes the key components of a clinical trial protocol. It discusses the types of clinical trials, phases of clinical trials, and the typical sections included in a protocol such as the title, objectives, study design, study population criteria, safety and efficacy assessments, statistics, and quality control plans. Protocols provide a formal design and plan for how a clinical trial will be conducted, managed, and reported.
Regulatory documents are required by health authorities before approval of new drugs, devices, or biologics. These documents include protocols, clinical study reports, investigator brochures, common technical documents, informed consent forms, and risk management plans. Protocols describe the study procedures and analysis plans. Clinical study reports integrate full study reports according to ICH guidelines. Investigator brochures provide safety information to investigators. Common technical documents assemble quality, safety, and efficacy data for regulatory submissions. Informed consent forms provide study information for participants. Risk management plans describe safety profiles and risk minimization plans.
DEVELOPING CLINICAL TRIAL PROTOCOL BY PRANAV LENDHEY.pptx36PranavLendhey
This document outlines the key components that should be included in a clinical trial protocol. It discusses that a protocol defines the objectives, methodology, organization and statistical analysis of a clinical trial. It provides details on important sections such as background information, study design, selection and withdrawal of subjects, assessment of safety and efficacy, statistics, quality control and assurance, ethics and financing. The development of a rigorous clinical trial protocol is essential to ensure the scientific integrity and credibility of the data obtained from the study.
The document provides an overview of the key components that should be included when developing a clinical trial protocol. It discusses that a protocol establishes the objectives, methodology, and organization of a clinical trial to ensure safety and integrity. The document then outlines the specific sections that are typically included in a protocol according to ICH guidelines, such as title, background, objectives, study design, eligibility criteria, treatment plan, safety monitoring, statistics, and informed consent procedures. It emphasizes that a protocol provides the details necessary to properly conduct a clinical investigation.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
This document summarizes the key components of a clinical trial protocol. It discusses the types of clinical trials, phases of clinical trials, and the typical sections included in a protocol such as the title, objectives, study design, study population criteria, safety and efficacy assessments, statistics, and quality control plans. Protocols provide a formal design and plan for how a clinical trial will be conducted, managed, and reported.
Regulatory documents are required by health authorities before approval of new drugs, devices, or biologics. These documents include protocols, clinical study reports, investigator brochures, common technical documents, informed consent forms, and risk management plans. Protocols describe the study procedures and analysis plans. Clinical study reports integrate full study reports according to ICH guidelines. Investigator brochures provide safety information to investigators. Common technical documents assemble quality, safety, and efficacy data for regulatory submissions. Informed consent forms provide study information for participants. Risk management plans describe safety profiles and risk minimization plans.
DEVELOPING CLINICAL TRIAL PROTOCOL BY PRANAV LENDHEY.pptx36PranavLendhey
This document outlines the key components that should be included in a clinical trial protocol. It discusses that a protocol defines the objectives, methodology, organization and statistical analysis of a clinical trial. It provides details on important sections such as background information, study design, selection and withdrawal of subjects, assessment of safety and efficacy, statistics, quality control and assurance, ethics and financing. The development of a rigorous clinical trial protocol is essential to ensure the scientific integrity and credibility of the data obtained from the study.
The document provides an overview of the key components that should be included when developing a clinical trial protocol. It discusses that a protocol establishes the objectives, methodology, and organization of a clinical trial to ensure safety and integrity. The document then outlines the specific sections that are typically included in a protocol according to ICH guidelines, such as title, background, objectives, study design, eligibility criteria, treatment plan, safety monitoring, statistics, and informed consent procedures. It emphasizes that a protocol provides the details necessary to properly conduct a clinical investigation.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
This document outlines a clinical research protocol template. It begins with an introduction section defining clinical research and clinical trials. It then describes the purpose and contents of a clinical research protocol, including sections for objectives, background/rationale, study design, eligibility criteria, treatments, assessments, data collection and analysis, monitoring, ethics and regulations. The protocol template provides guidance on the level of detail needed for each section to clearly explain the research question, methodology, and procedures to ensure scientific validity and participant safety.
The document discusses the process of clinical trials, including the phases involved from pre-clinical to post-marketing. It describes the goals of each phase from evaluating safety and efficacy on healthy volunteers to large patient groups. Regulatory authorities ensure quality and protect subject rights through establishing legal frameworks. Pharmacists play roles in storage, supply, patient education and conducting research to improve outcomes.
The document provides an overview of clinical study protocols, including their purpose, key components, and importance. It describes the various sections of a protocol, such as the background and objectives, study design, subject selection criteria, study procedures, safety and efficacy assessments, and data handling. Maintaining adherence to the protocol is important to ensure the safety of participants and integrity of the clinical trial.
This document discusses clinical trials and their various components. It begins with an introduction to clinical trials, their purpose and importance. It then describes the key elements of a clinical trial protocol including the trial design, eligibility criteria, safety measures, statistical analysis plan and informed consent process. It also discusses the role and composition of the Institutional Review Board/Independent Ethics Committee which reviews and approves clinical trial protocols and procedures. Finally, it provides an overview of the four phases of clinical trials and concludes with references.
This document provides an overview of conducting drug trials in cardiology. It discusses the definition and types of clinical trials, guidelines for trials including Good Clinical Practice and regulatory guidelines in India. Key elements of trials are covered such as the protocol, investigators, ethics committees, data collection and analysis. Equipoise, randomization, blinding and important considerations for trial design and conduct are also summarized.
Final navigating multiple clinical trial requirements for the usBhaswat Chakraborty
The title of the given topic mainly asks for technical, ethical and strategic aspects of multiple clinical trials that would result in a successful approval of an NDA by the US FDA. Other than Phase I studies aimed at safety and tolerance in healthy subjects, usually one or two exploratory (Phase II) and multiple confirmatory (Phase III) studies are required. Studies in Phase III need to be designed to confirm the findings in Phase II that a drug is safe and effective for use in the intended indication and recipient population. These studies provide an adequate basis for marketing approval. All clinical studies giving evidence of efficacy & safety must be adequate and well-controlled investigations entailing a valid comparison to a control and an accurate quantitative assessment of the drug’s effect. In rare situations, only a single, adequate and well-controlled study of a specific new use (that can be supported by information from other related adequate and well-controlled studies) will suffice for approval. However, when a single study is used, there should be hardly any room for study imperfections or non-supportive information.
In addition to addressing the strategies for multiple clinical trial requirements, the speaker would also discuss the documentation requirements and best practice on conducting effective clinical trials for the US to establish a roadmap for success and also a swift approval. Both documentation and best practices must contain a complete, entirely accurate, representation of study plans, conduct and outcomes. Incompleteness, lack of clarity, unmentioned deviation from prospectively planned analyses, or an inadequate description of how critical endpoint judgments or assessments were made, are seen to be common problems.
Genable Technologies is developing RhoNova, a gene therapy using two AAV vectors, for the treatment of rhodopsin-linked autosomal dominant retinitis pigmentosa (RHO-adRP), a genetic disorder causing progressive vision loss. RhoNova aims to overcome the diversity of over 200 RHO mutations by using RNA interference to destroy mutant RHO mRNA and replacing RHO through a gene resistant to mutations. Proof of concept has been shown in animal models. Orphan drug status has been granted and GMP manufacturing and preclinical toxicology studies are underway to enable clinical trials in 2017.
Therapeutic Goods Evaluation Panel Roadshow - Overview of Clinical EvaluationsTGA Australia
The document provides an overview of external evaluations of prescription medicines conducted by the Therapeutic Goods Administration (TGA) in Australia. It discusses the role of the TGA in regulating medicines and evaluating clinical data in applications. Clinical evaluators within the TGA are responsible for independently assessing application dossiers, summarizing the clinical data, and writing Clinical Evaluation Reports which make recommendations regarding approval and product information. The reports follow a template and guidelines to ensure a high-quality and rigorous evaluation is conducted.
Clinical trials involve several phases to test a drug's safety and efficacy. Phase I trials test safety in healthy volunteers. Phase II trials test dosage and side effects in patients. Phase III trials test efficacy in large patient groups. Legal and procedural aspects require ethics committee approval, informed consent, and regulatory oversight. Clinical trials involve clinical investigators, institutions to host the trial, sponsors to fund the trial, and regulatory authorities to provide legal approval. The clinical trial protocol, informed consent process, and role of ethics committees are important to protect patient rights and welfare in clinical research.
This document discusses the process of new drug evaluation, which involves 3 phases - drug discovery, preclinical testing, and clinical trials. In the drug discovery phase, candidate molecules are selected. Preclinical testing involves animal studies to evaluate safety. Clinical trials with human subjects are then conducted in 3 phases to evaluate efficacy, safety, and adverse effects. The clinical trials process is highly regulated to ensure safety and data integrity. If successful, a New Drug Application is filed with regulatory authorities for approval to market the new drug.
Preparation of Clinical Trial Protocol of India.Aakashdeep Raval
The document provides information on clinical trial protocols in India. It discusses the purpose of clinical trials and phases of clinical trials from Phase 0 to Phase 4. It explains that the clinical trial protocol is a document that states the background, objectives, design, methodology and statistical considerations of a clinical trial. The protocol describes inclusion/exclusion criteria, assessments of efficacy and safety, data management, quality control and other key elements to ensure proper conduct of the clinical trial. An effective clinical trial protocol provides all the necessary details to guide researchers in safely and ethically evaluating a medical treatment.
This document discusses pharmacovigilance in clinical trials, which involves monitoring the safety of medicines being tested. It outlines the responsibilities of various stakeholders like sponsors, investigators, and regulators in pharmacovigilance activities like adverse event reporting, risk assessment, and safety monitoring. Key aspects covered are the protocol guidance for safety reporting, use of case report forms and investigator brochures to document adverse drug reactions, and management of safety issues that arise during trials.
Health Canada's Clinical Evaluation Division chief Jian Wang presented on clinical data requirements and key issues for market authorization of biotherapeutics. Wang discussed Health Canada's international collaborations and highlighted regulatory authorities' decision-making based on efficacy and safety. He outlined submission data requirements including quality, non-clinical, clinical, and risk management data. Wang also reviewed key clinical trial design considerations and common efficacy and safety issues with biologics. He emphasized that benefit-risk assessments are context-specific and can lead different regulatory decisions in different jurisdictions based on the same data.
This document outlines the requirements and contents of an Investigator's Brochure (IB), which provides investigators involved in clinical trials with information on the investigational product. The IB includes a summary of relevant nonclinical and clinical data, including pharmacology, toxicology from animal studies, pharmacokinetics in humans, safety and efficacy results from previous clinical trials, and marketing experience with the product. It also provides guidance to investigators on conducting the clinical trial safely and effectively. The goal of the IB is to inform investigators about the rationale for the clinical trial and enable them to independently assess the risk-benefit of the investigational product.
This document discusses the requirements and contents of an Investigator's Brochure (IB) and Investigational Medicinal Product Dossier (IMPD). The IB is intended to inform investigators about the investigational product and facilitate their understanding of the clinical trial. It includes summaries of nonclinical and clinical data, adverse reactions, and guidance for investigators. The IMPD provides the basis for approval of clinical trials in the EU. It includes quality, nonclinical, clinical, and risk-benefit data for the investigational product as well as other required documents and forms. Both the IB and IMPD aim to ensure the safety of clinical trials and protection of human subjects.
The document provides details on clinical trial protocols, investigator's brochures, and case report forms (CRFs). It discusses the key elements that should be included in clinical trial protocols like background information, objectives, trial design, selection and withdrawal of subjects, treatment, efficacy and safety assessments, and statistics. It also describes the purpose and contents of investigator's brochures and CRFs which are important documents used in clinical trials to capture subject data and report trial results. CRFs help ensure accurate collection, analysis and reporting of trial data.
summary report of inspections of clinical trials conducted from April 2004 to...mahmoudnasseri
This document summarizes Health Canada inspections of clinical trials conducted from 2004 to 2011. During this period, 329 inspections found 3148 observations of non-compliance, mostly related to quality systems/procedures and record keeping. 92% of inspections were rated compliant and 8% non-compliant. Common deficiencies included lack of standard operating procedures, inadequate documentation and personnel training. The report aims to increase awareness of regulatory requirements and improve compliance for protecting clinical trial participants.
1. The document discusses regulatory requirements for drug approval, including non-clinical and clinical studies that must be conducted and submitted to regulatory agencies like the FDA.
2. It describes the various teams involved in drug development, including discovery, preclinical, clinical, manufacturing, and marketing teams. The responsibilities and roles of each team are provided.
3. The approval process is outlined, including requirements for an Investigational New Drug (IND) application to the FDA. The IND must provide data from animal and other preclinical studies. It allows clinical trials to proceed if approved by the FDA within 30 days.
Authoring a personal GPT for your research and practice: How we created the Q...Leonel Morgado
Thematic analysis in qualitative research is a time-consuming and systematic task, typically done using teams. Team members must ground their activities on common understandings of the major concepts underlying the thematic analysis, and define criteria for its development. However, conceptual misunderstandings, equivocations, and lack of adherence to criteria are challenges to the quality and speed of this process. Given the distributed and uncertain nature of this process, we wondered if the tasks in thematic analysis could be supported by readily available artificial intelligence chatbots. Our early efforts point to potential benefits: not just saving time in the coding process but better adherence to criteria and grounding, by increasing triangulation between humans and artificial intelligence. This tutorial will provide a description and demonstration of the process we followed, as two academic researchers, to develop a custom ChatGPT to assist with qualitative coding in the thematic data analysis process of immersive learning accounts in a survey of the academic literature: QUAL-E Immersive Learning Thematic Analysis Helper. In the hands-on time, participants will try out QUAL-E and develop their ideas for their own qualitative coding ChatGPT. Participants that have the paid ChatGPT Plus subscription can create a draft of their assistants. The organizers will provide course materials and slide deck that participants will be able to utilize to continue development of their custom GPT. The paid subscription to ChatGPT Plus is not required to participate in this workshop, just for trying out personal GPTs during it.
This document outlines a clinical research protocol template. It begins with an introduction section defining clinical research and clinical trials. It then describes the purpose and contents of a clinical research protocol, including sections for objectives, background/rationale, study design, eligibility criteria, treatments, assessments, data collection and analysis, monitoring, ethics and regulations. The protocol template provides guidance on the level of detail needed for each section to clearly explain the research question, methodology, and procedures to ensure scientific validity and participant safety.
The document discusses the process of clinical trials, including the phases involved from pre-clinical to post-marketing. It describes the goals of each phase from evaluating safety and efficacy on healthy volunteers to large patient groups. Regulatory authorities ensure quality and protect subject rights through establishing legal frameworks. Pharmacists play roles in storage, supply, patient education and conducting research to improve outcomes.
The document provides an overview of clinical study protocols, including their purpose, key components, and importance. It describes the various sections of a protocol, such as the background and objectives, study design, subject selection criteria, study procedures, safety and efficacy assessments, and data handling. Maintaining adherence to the protocol is important to ensure the safety of participants and integrity of the clinical trial.
This document discusses clinical trials and their various components. It begins with an introduction to clinical trials, their purpose and importance. It then describes the key elements of a clinical trial protocol including the trial design, eligibility criteria, safety measures, statistical analysis plan and informed consent process. It also discusses the role and composition of the Institutional Review Board/Independent Ethics Committee which reviews and approves clinical trial protocols and procedures. Finally, it provides an overview of the four phases of clinical trials and concludes with references.
This document provides an overview of conducting drug trials in cardiology. It discusses the definition and types of clinical trials, guidelines for trials including Good Clinical Practice and regulatory guidelines in India. Key elements of trials are covered such as the protocol, investigators, ethics committees, data collection and analysis. Equipoise, randomization, blinding and important considerations for trial design and conduct are also summarized.
Final navigating multiple clinical trial requirements for the usBhaswat Chakraborty
The title of the given topic mainly asks for technical, ethical and strategic aspects of multiple clinical trials that would result in a successful approval of an NDA by the US FDA. Other than Phase I studies aimed at safety and tolerance in healthy subjects, usually one or two exploratory (Phase II) and multiple confirmatory (Phase III) studies are required. Studies in Phase III need to be designed to confirm the findings in Phase II that a drug is safe and effective for use in the intended indication and recipient population. These studies provide an adequate basis for marketing approval. All clinical studies giving evidence of efficacy & safety must be adequate and well-controlled investigations entailing a valid comparison to a control and an accurate quantitative assessment of the drug’s effect. In rare situations, only a single, adequate and well-controlled study of a specific new use (that can be supported by information from other related adequate and well-controlled studies) will suffice for approval. However, when a single study is used, there should be hardly any room for study imperfections or non-supportive information.
In addition to addressing the strategies for multiple clinical trial requirements, the speaker would also discuss the documentation requirements and best practice on conducting effective clinical trials for the US to establish a roadmap for success and also a swift approval. Both documentation and best practices must contain a complete, entirely accurate, representation of study plans, conduct and outcomes. Incompleteness, lack of clarity, unmentioned deviation from prospectively planned analyses, or an inadequate description of how critical endpoint judgments or assessments were made, are seen to be common problems.
Genable Technologies is developing RhoNova, a gene therapy using two AAV vectors, for the treatment of rhodopsin-linked autosomal dominant retinitis pigmentosa (RHO-adRP), a genetic disorder causing progressive vision loss. RhoNova aims to overcome the diversity of over 200 RHO mutations by using RNA interference to destroy mutant RHO mRNA and replacing RHO through a gene resistant to mutations. Proof of concept has been shown in animal models. Orphan drug status has been granted and GMP manufacturing and preclinical toxicology studies are underway to enable clinical trials in 2017.
Therapeutic Goods Evaluation Panel Roadshow - Overview of Clinical EvaluationsTGA Australia
The document provides an overview of external evaluations of prescription medicines conducted by the Therapeutic Goods Administration (TGA) in Australia. It discusses the role of the TGA in regulating medicines and evaluating clinical data in applications. Clinical evaluators within the TGA are responsible for independently assessing application dossiers, summarizing the clinical data, and writing Clinical Evaluation Reports which make recommendations regarding approval and product information. The reports follow a template and guidelines to ensure a high-quality and rigorous evaluation is conducted.
Clinical trials involve several phases to test a drug's safety and efficacy. Phase I trials test safety in healthy volunteers. Phase II trials test dosage and side effects in patients. Phase III trials test efficacy in large patient groups. Legal and procedural aspects require ethics committee approval, informed consent, and regulatory oversight. Clinical trials involve clinical investigators, institutions to host the trial, sponsors to fund the trial, and regulatory authorities to provide legal approval. The clinical trial protocol, informed consent process, and role of ethics committees are important to protect patient rights and welfare in clinical research.
This document discusses the process of new drug evaluation, which involves 3 phases - drug discovery, preclinical testing, and clinical trials. In the drug discovery phase, candidate molecules are selected. Preclinical testing involves animal studies to evaluate safety. Clinical trials with human subjects are then conducted in 3 phases to evaluate efficacy, safety, and adverse effects. The clinical trials process is highly regulated to ensure safety and data integrity. If successful, a New Drug Application is filed with regulatory authorities for approval to market the new drug.
Preparation of Clinical Trial Protocol of India.Aakashdeep Raval
The document provides information on clinical trial protocols in India. It discusses the purpose of clinical trials and phases of clinical trials from Phase 0 to Phase 4. It explains that the clinical trial protocol is a document that states the background, objectives, design, methodology and statistical considerations of a clinical trial. The protocol describes inclusion/exclusion criteria, assessments of efficacy and safety, data management, quality control and other key elements to ensure proper conduct of the clinical trial. An effective clinical trial protocol provides all the necessary details to guide researchers in safely and ethically evaluating a medical treatment.
This document discusses pharmacovigilance in clinical trials, which involves monitoring the safety of medicines being tested. It outlines the responsibilities of various stakeholders like sponsors, investigators, and regulators in pharmacovigilance activities like adverse event reporting, risk assessment, and safety monitoring. Key aspects covered are the protocol guidance for safety reporting, use of case report forms and investigator brochures to document adverse drug reactions, and management of safety issues that arise during trials.
Health Canada's Clinical Evaluation Division chief Jian Wang presented on clinical data requirements and key issues for market authorization of biotherapeutics. Wang discussed Health Canada's international collaborations and highlighted regulatory authorities' decision-making based on efficacy and safety. He outlined submission data requirements including quality, non-clinical, clinical, and risk management data. Wang also reviewed key clinical trial design considerations and common efficacy and safety issues with biologics. He emphasized that benefit-risk assessments are context-specific and can lead different regulatory decisions in different jurisdictions based on the same data.
This document outlines the requirements and contents of an Investigator's Brochure (IB), which provides investigators involved in clinical trials with information on the investigational product. The IB includes a summary of relevant nonclinical and clinical data, including pharmacology, toxicology from animal studies, pharmacokinetics in humans, safety and efficacy results from previous clinical trials, and marketing experience with the product. It also provides guidance to investigators on conducting the clinical trial safely and effectively. The goal of the IB is to inform investigators about the rationale for the clinical trial and enable them to independently assess the risk-benefit of the investigational product.
This document discusses the requirements and contents of an Investigator's Brochure (IB) and Investigational Medicinal Product Dossier (IMPD). The IB is intended to inform investigators about the investigational product and facilitate their understanding of the clinical trial. It includes summaries of nonclinical and clinical data, adverse reactions, and guidance for investigators. The IMPD provides the basis for approval of clinical trials in the EU. It includes quality, nonclinical, clinical, and risk-benefit data for the investigational product as well as other required documents and forms. Both the IB and IMPD aim to ensure the safety of clinical trials and protection of human subjects.
The document provides details on clinical trial protocols, investigator's brochures, and case report forms (CRFs). It discusses the key elements that should be included in clinical trial protocols like background information, objectives, trial design, selection and withdrawal of subjects, treatment, efficacy and safety assessments, and statistics. It also describes the purpose and contents of investigator's brochures and CRFs which are important documents used in clinical trials to capture subject data and report trial results. CRFs help ensure accurate collection, analysis and reporting of trial data.
summary report of inspections of clinical trials conducted from April 2004 to...mahmoudnasseri
This document summarizes Health Canada inspections of clinical trials conducted from 2004 to 2011. During this period, 329 inspections found 3148 observations of non-compliance, mostly related to quality systems/procedures and record keeping. 92% of inspections were rated compliant and 8% non-compliant. Common deficiencies included lack of standard operating procedures, inadequate documentation and personnel training. The report aims to increase awareness of regulatory requirements and improve compliance for protecting clinical trial participants.
1. The document discusses regulatory requirements for drug approval, including non-clinical and clinical studies that must be conducted and submitted to regulatory agencies like the FDA.
2. It describes the various teams involved in drug development, including discovery, preclinical, clinical, manufacturing, and marketing teams. The responsibilities and roles of each team are provided.
3. The approval process is outlined, including requirements for an Investigational New Drug (IND) application to the FDA. The IND must provide data from animal and other preclinical studies. It allows clinical trials to proceed if approved by the FDA within 30 days.
Authoring a personal GPT for your research and practice: How we created the Q...Leonel Morgado
Thematic analysis in qualitative research is a time-consuming and systematic task, typically done using teams. Team members must ground their activities on common understandings of the major concepts underlying the thematic analysis, and define criteria for its development. However, conceptual misunderstandings, equivocations, and lack of adherence to criteria are challenges to the quality and speed of this process. Given the distributed and uncertain nature of this process, we wondered if the tasks in thematic analysis could be supported by readily available artificial intelligence chatbots. Our early efforts point to potential benefits: not just saving time in the coding process but better adherence to criteria and grounding, by increasing triangulation between humans and artificial intelligence. This tutorial will provide a description and demonstration of the process we followed, as two academic researchers, to develop a custom ChatGPT to assist with qualitative coding in the thematic data analysis process of immersive learning accounts in a survey of the academic literature: QUAL-E Immersive Learning Thematic Analysis Helper. In the hands-on time, participants will try out QUAL-E and develop their ideas for their own qualitative coding ChatGPT. Participants that have the paid ChatGPT Plus subscription can create a draft of their assistants. The organizers will provide course materials and slide deck that participants will be able to utilize to continue development of their custom GPT. The paid subscription to ChatGPT Plus is not required to participate in this workshop, just for trying out personal GPTs during it.
PPT on Direct Seeded Rice presented at the three-day 'Training and Validation Workshop on Modules of Climate Smart Agriculture (CSA) Technologies in South Asia' workshop on April 22, 2024.
Current Ms word generated power point presentation covers major details about the micronuclei test. It's significance and assays to conduct it. It is used to detect the micronuclei formation inside the cells of nearly every multicellular organism. It's formation takes place during chromosomal sepration at metaphase.
Or: Beyond linear.
Abstract: Equivariant neural networks are neural networks that incorporate symmetries. The nonlinear activation functions in these networks result in interesting nonlinear equivariant maps between simple representations, and motivate the key player of this talk: piecewise linear representation theory.
Disclaimer: No one is perfect, so please mind that there might be mistakes and typos.
dtubbenhauer@gmail.com
Corrected slides: dtubbenhauer.com/talks.html
(June 12, 2024) Webinar: Development of PET theranostics targeting the molecu...Scintica Instrumentation
Targeting Hsp90 and its pathogen Orthologs with Tethered Inhibitors as a Diagnostic and Therapeutic Strategy for cancer and infectious diseases with Dr. Timothy Haystead.
EWOCS-I: The catalog of X-ray sources in Westerlund 1 from the Extended Weste...Sérgio Sacani
Context. With a mass exceeding several 104 M⊙ and a rich and dense population of massive stars, supermassive young star clusters
represent the most massive star-forming environment that is dominated by the feedback from massive stars and gravitational interactions
among stars.
Aims. In this paper we present the Extended Westerlund 1 and 2 Open Clusters Survey (EWOCS) project, which aims to investigate
the influence of the starburst environment on the formation of stars and planets, and on the evolution of both low and high mass stars.
The primary targets of this project are Westerlund 1 and 2, the closest supermassive star clusters to the Sun.
Methods. The project is based primarily on recent observations conducted with the Chandra and JWST observatories. Specifically,
the Chandra survey of Westerlund 1 consists of 36 new ACIS-I observations, nearly co-pointed, for a total exposure time of 1 Msec.
Additionally, we included 8 archival Chandra/ACIS-S observations. This paper presents the resulting catalog of X-ray sources within
and around Westerlund 1. Sources were detected by combining various existing methods, and photon extraction and source validation
were carried out using the ACIS-Extract software.
Results. The EWOCS X-ray catalog comprises 5963 validated sources out of the 9420 initially provided to ACIS-Extract, reaching a
photon flux threshold of approximately 2 × 10−8 photons cm−2
s
−1
. The X-ray sources exhibit a highly concentrated spatial distribution,
with 1075 sources located within the central 1 arcmin. We have successfully detected X-ray emissions from 126 out of the 166 known
massive stars of the cluster, and we have collected over 71 000 photons from the magnetar CXO J164710.20-455217.
Immersive Learning That Works: Research Grounding and Paths ForwardLeonel Morgado
We will metaverse into the essence of immersive learning, into its three dimensions and conceptual models. This approach encompasses elements from teaching methodologies to social involvement, through organizational concerns and technologies. Challenging the perception of learning as knowledge transfer, we introduce a 'Uses, Practices & Strategies' model operationalized by the 'Immersive Learning Brain' and ‘Immersion Cube’ frameworks. This approach offers a comprehensive guide through the intricacies of immersive educational experiences and spotlighting research frontiers, along the immersion dimensions of system, narrative, and agency. Our discourse extends to stakeholders beyond the academic sphere, addressing the interests of technologists, instructional designers, and policymakers. We span various contexts, from formal education to organizational transformation to the new horizon of an AI-pervasive society. This keynote aims to unite the iLRN community in a collaborative journey towards a future where immersive learning research and practice coalesce, paving the way for innovative educational research and practice landscapes.
Describing and Interpreting an Immersive Learning Case with the Immersion Cub...Leonel Morgado
Current descriptions of immersive learning cases are often difficult or impossible to compare. This is due to a myriad of different options on what details to include, which aspects are relevant, and on the descriptive approaches employed. Also, these aspects often combine very specific details with more general guidelines or indicate intents and rationales without clarifying their implementation. In this paper we provide a method to describe immersive learning cases that is structured to enable comparisons, yet flexible enough to allow researchers and practitioners to decide which aspects to include. This method leverages a taxonomy that classifies educational aspects at three levels (uses, practices, and strategies) and then utilizes two frameworks, the Immersive Learning Brain and the Immersion Cube, to enable a structured description and interpretation of immersive learning cases. The method is then demonstrated on a published immersive learning case on training for wind turbine maintenance using virtual reality. Applying the method results in a structured artifact, the Immersive Learning Case Sheet, that tags the case with its proximal uses, practices, and strategies, and refines the free text case description to ensure that matching details are included. This contribution is thus a case description method in support of future comparative research of immersive learning cases. We then discuss how the resulting description and interpretation can be leveraged to change immersion learning cases, by enriching them (considering low-effort changes or additions) or innovating (exploring more challenging avenues of transformation). The method holds significant promise to support better-grounded research in immersive learning.
2. PRE CLINICAL STUDIES
Preclinical studies or tests are mainly performed in compliance with GLP/GSP guidelines (good
laboratory practice and good scientific practices) to ensure reliability and reproducibility of results.
The FDA/EMA require supporting basic preclinical data to IND application especially on toxic
effects, safety profile, pharmacokinetics, and pharmacodynamics.
The data from preclinical trials must be accurate, reliable, and based on the best suitable and
comparable model available to the target population.
Typically, this means that the IND or drug product must undergo a series of robust tests and
experiments using in vitro, in vivo, ex vivo, and in silico models as per the needs of the focused
indication and regulatory guidelines.
2
Performed in- in vitro
- in vivo
- ex vivo
- silico models
To obtain basic information about the safety and
biological efficacy of a drug candidate before testing it in
a final target population, i.e., humans.
4. THE CLINICAL DEVELOPMENT PLAN
The safety and toxicity data generated from pre- clinical studies enables the drug
company to safely initiate clinical trials.
The scope and duration of these trials will vary widely, depending on the nature of
the drug and its therapeutic application.
Clinical trials on patients in the different countries are approved and monitored by
different regulatory agencies like:
i) DCGI (Drugs Controller General of India) under CDSCO (Central Drug
Standard Control Organization)- in India
ii) MHRA ( Medicines and Healthcare Products Regulatory agency) advised by
Committee of Safety of Medicines(CAM)- UK
iii) FDA (Food and Drug Administration)- USA
4
5. 5
• A clinical development plan is put together before starting a clinical
trial.
• It is a comprehensive plan designed to map out the development
of a drug compound from early Phase I studies through marketing.
• It consists of the following:
i) Summary of the pre clinical findings
ii) Market research done for the drug
• The clinical development plan usually consists of :
i) Target dates for the studies.
ii) Objectives of each study.
iii) proposed study design for achieving the objectives.
• A clinical development plan covers the studies required for
registration and approval.
6. 6
PHASES OF CLINICAL RESEARCH
Clinical research is done in 4 phases (I, II, III, IV) each designed to address
different questions.
Research in a particular phase may continue after the drug has progressed to
go further stages of development.
Based upon the data gathered from the Pre clinical (animal testing) trials, the
sponsor has some estimation of :
- The drugs therapeutic effects and dose levels
- Toxicity profile and dose levels.
This information is used to design Phase I clinical Trial.
8. 8
Only 70% of experimental
drugs pass Phase I clinical
trial
Only 35% of experimental
drugs pass Phase II clinical
trial
Only 25% of experimental
drugs pass Phase III
clinical trial
Only 1 in every 3 drugs
which reaches the market
regains its developmental
costs.
9. PRECLINICAL STUDY MANAGEMENT
Preclinical Study Management
• Bid solicitation and laboratory selection
• Protocol development
• Data and report review
• On-site study monitoring and preparation
of study monitoring reports
• Preclinical project management
• Central point of contact for study-related
communication
• Development and maintenance of
timelines and budgets for preclinical
programs
Compliance
• GLP prequalification and auditing
• Data audits to supplement or overlap a
CRO’s inspection
• Standard operating procedures review and
development
9
10. 10
ESSENTIAL DOCUMENTS FOR CLINICAL TRIALS
The essential documents for clinical trials are the following:
• Protocol
• Investigator's Brochure
• Subject Information and Informed Consent Form
• Clinical Study Reports
• Case Report Form (CRF)
• Regulatory Approval
• ERB/IRB/EC Approval
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PROTOCOL
A Document that states the background, objectives, rationale, design,
methodology, ( including methods to deal with AEs, withdrawals etc… along with
statistical considerations of the study.
The following sections should be included in the Study Protocol:
•Introduction (brief description of the problem and treatment
regimen(s))
•Objectives and purposes of the study
•Study duration
•Number of subjects
•Informed Consent
•Opinion of the Ethics Committee
•Subject selection criteria:
• Inclusion criteria
• Exclusion criteria
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•Methodology:
• Study Plan
• Study schedule
• Study Visits
• Study Assessments / Procedures
• Definition of efficacy endpoints
• Treatment cycles
•Safety Reporting
• Adverse events (AEs)
• Serious adverse events (SAEs)
• Abnormal laboratory test values
• Abnormal values of other safety parameters
• Withdrawal from the Study
•Clinical laboratory parameters
•Other safety parameters
•Concomitant medications
•Data analysis
•Appendixes
The following appendixes may be included in the Study Protocol: Patient Information Sheet/Written information
and/or Informed consent form (ICF). Instruction sheet (e.g. for study subjects or study site staff).
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INVESTIGATOR'S BROCHURE (IB):
• Contains pre-clinical and clinical information related to an investigational drug.
• The information should be presented in a concise, simple, objective, balanced form that should
be taken into account during translation.
• The Investigator's Brochure includes - Title Page, which provides the Sponsor's name
- the identity of investigational product (products)
- an edition number and date
- the number and date of the edition it supersedes as well.
The Sponsor may wish to include a Confidentiality Statement instructing to treat the IB as a
confidential document.
PROTOCOL AMENDMENT
Protocol amendment describes major changes to the initial Study Protocol. Protocol amendment
must be again approved by the Ethics Committee.
14. 14
INFORMED CONSENT
• Informed consent is a process by which a subject voluntary confirms his/her
willingness to participate in one or another clinical trial, after having been
informed of all aspects of the study.
• Informed consent should be documented by means of a written, signed and
dated Informed Consent Form (ICF).
The main principles of Informed consent
The subject should be informed of the following:
•the purposes of the trial;
•the methods of the trial;
•the study drug(s) and treatment regimens;
•available alternative treatment(s);
•the potential risks and benefits, and possible discomforts.
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STUDY PROGRESS REPORTS
• The Investigator should provide written reports on study progress to the Ethics
Committee.
• These may be the Interim report on the interim results of the study and their assessment
based on the analysis conducted in the course of the study, or the Final report - full,
comprehensive description of the study including description of investigational materials,
study design, and presentation and assessment of results of statistical analysis.
• Additionally, the Investigator should prepare the written reports on all major changes that
might affect study conduction and/or increase risk to study subjects.
• These are the following: Adverse Event Report or Adverse Drug Reaction Report, Patient
Entry Form(Patient Entry Card/Patient Notification Form) and Patient Withdrawal Form,
Protocol Deviation/Violation Report, Study Termination Report etc.
16. 16
CASE RECORD FORM (CRF)
Case record form is a paper or electronic document designed to record all the information for
an individual study subject required by the Study protocol.
The Case record form is used for several purposes:
•to ensure data collection in accordance with the Study protocol;
•to ensure fulfilling of the regulatory authorities' requirements for data collection;
•to facilitate the effective, comprehensive data processing and analysis, results reporting, and to
promote the safety data sharing between the study team and other departments of the
institution.
All CRF's should include the following data:
• study title and number;
• Investigator's name;
• study subject/patient ID (number and initials);
• inclusion / exclusion criteria;
• demographic data;
• detailed description of dosage regimens of investigational drug;
• concomitant treatment;
• adverse events (side effects and intercurrent diseases);
• conclusion on subject's health;
• Investigator's signature and date.
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Additionally, the CRF's should include special pages to record the
following information:
•past medical history;
•results of physical examination;
•primary and secondary diagnoses;
•relevant previous treatment;
•baseline characteristics, results of interim assessments, evaluation of
efficacy endpoints, laboratory tests, description of study procedures etc.
All CRF's should be legible and suitable for duplication and possible
additional sharing.
18. 18
ICH GCP - Essential documents for the conduct of a clinical
trial - ICH GCP
https://www.bing.com/search?q=documents+required+for+initiating+a+study+in+clinical+research&cv
id=7410340d93ad439d9482f96816499bf9&aqs=edge..69i57.18846j0j4&FORM=ANAB01&PC=HCTS&ntr
ef=1
19. ROLES AND RESPONSIBILITIES OF INVESTIGATORS
•By submitting a protocol to the IRB, and being named as the principal investigator (PI) of that
study, the PI is agreeing to assume the overall responsibility for the study conduct. By doing so,
they are agreeing to:
•personally conduct or supervise the research;
•ensure that each individual to whom a task is delegated, is qualified by virtue of education,
training, and experience (e.g., hospital certification, human subjects research training, state license)
to perform each of their delegated tasks;
•protect the rights, safety and welfare of the participants who will be under their care. To do this
they are agreeing that the research :
• is conducted in accordance with all federal regulatory requirements, state law (including IRB
SOPs);
• is conducted in accordance with the IRB approved plan; and
• that they will ensure the accuracy, security and integrity of the research data and the
subsequent analysis of that data. 19
20. 20
According to FDA regulations
21 CFR 312.60 An investigator is responsible for ensuring that an investigation is conducted
according to the signed investigator statement (the FDA's 1572 form), the investigational
plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects
under the investigator's care; and for the control of drugs under investigation.
An investigator shall, obtain the informed consent of each human subject to whom the drug
is administered.
21. 21
Responsibilities Related to the Conduct of Human Subjects Research
The principal investigator is responsible for ensuring that:
•The protocol is scientifically sound and of scientific and social value;
•There are adequate resources - time, funding, space, staff - to conduct the research;
•They will provide sufficient oversight over all study activities and tasks delegated to others to ensure
that the research is conducted in compliance with all applicable Federal Regulations and
CHOP Policies and Procedures;
•IRB approval will be obtained before starting the study (enrolling subjects);
•After the research is approved, all required reports including: continuing review progress
reports, unanticipated problems, protocol deviations - will be submitted to the IRB, the study sponsor
and the relevant funding agencies in accordance with the CHOP IRB Policies and Procedures and
sponsor/funding agency requirements;
22. WHO IS ELIGIBLE TO BE A PRINCIPAL INVESTIGATOR?
Before you begin to develop a proposal, it is important to be sure you are eligible to serve as a
Principal Investigator.
Anyone holding the following positions may be designated as PIs in applications for sponsored
projects:
1.All Assistant, Associate, and Full Professors
2.All Research Assistant Professors, Research Associate Professors, Research Professors, Extension
Specialists, Clinical Professors, and Senior Research Fellows
3.All Adjunct, Visiting, Lecturers or other faculty who have the approval of their Department and the
approval of the Dean of the relevant School or College. PIs in this category should either include a Co-
PI from appointment types or provide a signed memo where the Chair and Dean shall accept full fiscal
and administrative liability and responsibility for the actions of the Principal Investigator included in
this category.
4.All Post-Doctoral Fellows who have the approval of their Department and the approval of the Dean
of the relevant School or College. The Post-Doctoral Fellow’s mentor must be included as a Co-PI.
5.All Professional Staff also students with the approval of their Department and the approval of the
Dean of the relevant School, College, or Vice Chancellor.
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