TMF Fundamentals - An Introduction to Better Trial Master File Management - M...Montrium
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
DIA Reference Model a Guidance for Good Document Management and eTMFSagar Ghotekar
The TMF Reference Model is managed under the Drug Information Association (DIA) Document and Records Management Community. The TMF Reference Model Provides Standardized Taxonomy and Metadata & outlines a reference definition of TMF content using standard Nomenclature.
Since its release in 2010, The DIA’s TMF Reference Model has proven to be extremely valuable to the life sciences industry. In this content-packed webinar, we will provide a history and overview of the Model, present its structure, and the various sub-groups and resources available. The Model is not intended to be used “off-the-shelf" but can be implemented according to certain expectations and requirements of life science sponsors (pharma, bio, device), investigative sites (academic, for-profit, nonprofit) and CROs / third-party team members alike.
Paul Fenton, CEO of Montrium and CGI Life Science’s Fran Ross, both Members of the TMF Reference Model Steering Committee, will discuss strategies for implementing the Model and how it can be used to ensure tight controls of GxP required content for inspection. Finally, the session will present the TMF Reference Model Exchange Mechanism Standard which extends the Model's capability to facilitate eTMF interoperability and content exchange.
This presentation describes a case study of an eTMF structure, setup, and implementation at a biotechnology company currently conducting a pivotal Phase 3 clinical study in 70 centers worldwide.
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
Reconciliation and Literature Review and Signal Detection_Katalyst HLSKatalyst HLS
Introduction Reconciliation and Literature Review and Signal Detection 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
Using Vault eTMF Milestones and EDLs to Support Inspection ReadinessVeeva Systems
Hear how Daiichi Sankyo is using milestones and expected document lists (EDLs) to enable ongoing inspection readiness and proactive TMF management and oversight.
In our upcoming webinar, we will be exploring how dividing responsibilities between CRO and Sponsor in an outsourcing model can be leveraged to improve the quality of your trials. We'll start by diving in to the world of outsourcing and what roles different organizations can play, and then explore some of the ways technology can enable outsourced TMF management to operate smoothly.
TMF Fundamentals - An Introduction to Better Trial Master File Management - M...Montrium
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
DIA Reference Model a Guidance for Good Document Management and eTMFSagar Ghotekar
The TMF Reference Model is managed under the Drug Information Association (DIA) Document and Records Management Community. The TMF Reference Model Provides Standardized Taxonomy and Metadata & outlines a reference definition of TMF content using standard Nomenclature.
Since its release in 2010, The DIA’s TMF Reference Model has proven to be extremely valuable to the life sciences industry. In this content-packed webinar, we will provide a history and overview of the Model, present its structure, and the various sub-groups and resources available. The Model is not intended to be used “off-the-shelf" but can be implemented according to certain expectations and requirements of life science sponsors (pharma, bio, device), investigative sites (academic, for-profit, nonprofit) and CROs / third-party team members alike.
Paul Fenton, CEO of Montrium and CGI Life Science’s Fran Ross, both Members of the TMF Reference Model Steering Committee, will discuss strategies for implementing the Model and how it can be used to ensure tight controls of GxP required content for inspection. Finally, the session will present the TMF Reference Model Exchange Mechanism Standard which extends the Model's capability to facilitate eTMF interoperability and content exchange.
This presentation describes a case study of an eTMF structure, setup, and implementation at a biotechnology company currently conducting a pivotal Phase 3 clinical study in 70 centers worldwide.
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
Reconciliation and Literature Review and Signal Detection_Katalyst HLSKatalyst HLS
Introduction Reconciliation and Literature Review and Signal Detection 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
Using Vault eTMF Milestones and EDLs to Support Inspection ReadinessVeeva Systems
Hear how Daiichi Sankyo is using milestones and expected document lists (EDLs) to enable ongoing inspection readiness and proactive TMF management and oversight.
In our upcoming webinar, we will be exploring how dividing responsibilities between CRO and Sponsor in an outsourcing model can be leveraged to improve the quality of your trials. We'll start by diving in to the world of outsourcing and what roles different organizations can play, and then explore some of the ways technology can enable outsourced TMF management to operate smoothly.
Review of essential documents (TMF BABE).Piyush Wagh
This ppt is useful for the Clinical Auditors (BABE), it helps in reviewing of essential documents and compilation of essential documents during clinical phase. Bioequivalence
Essential Regulatory Documents in Clinical TrialsTrialJoin
The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc.
Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
Clinical Data Management Interview question Part II.ClinosolIndia
The guide emphasizes the importance of understanding the fundamental principles of CDM and provides practical examples and scenarios to help you demonstrate your expertise and problem-solving skills. It also offers guidance on how to showcase your knowledge of industry regulations and guidelines, such as Good Clinical Data Management Practices (GCDMP) and Good Clinical Practice (GCP).
By familiarizing yourself with the interview questions and utilizing the suggested strategies and tips provided, you will be well-prepared to articulate your knowledge, skills, and experience in CDM during your interviews. This resource aims to enhance your interview performance and increase your chances of securing a position in the competitive field of Clinical Data Management.
Whether you are applying for a CDM role in a pharmaceutical company, contract research organization (CRO), or academic institution, CDM Interview Question Part I is an invaluable tool to help you navigate the interview process and stand out as a strong candidate.
Argus Screen Shots General Tab - Katalyst HLSKatalyst HLS
Introduction to Argus Screen Shots General Tab - Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Explaining the Importance of Feasibility Questionnaires and Site Selection Vi...TrialJoin
No matter if you’re reading this because you aspire to become a CRA, or you’re a study coordinator, or maybe you’re part of a research site, learning about feasibility surveys and questionnaires is important for everyone that’s in any way involved in clinical trials.
In this article, we’ll try to explain to you why feasibility questionnaires and site selection visits are important and how they can affect the sponsor’s decision of awarding you the study.
Clireo eTMF Solution by Arivis
What is Clireo?
• Comprehensive Software and Service enabling the Trial Master File
• Compliant with the DIA Trial Master File Reference Model Version 3
• Assign access and maintain control of Sites, Vendors, and Auditors for content.
• Eliminate CRA need to reconcile the Investigator Site File against the Sponsor TMF.
• Part 21 CFR 11 Digital signatures allow for faster turn around time on documents.
• Ability to quickly disseminate new information to users that the information is relevant to.
• Vendors and Sites can upload documentation and data directly into Clireo.
• Unlimited storage capacity assures that all documentation can be held in one location.
• No additional hardware required to implement.
• Dashboard reports on the status of sites and documents to easily identify missing or lagging information.
• Protect documents against unauthorized modification.
• Supports single or multiple file uploads with single screen metadata tagging.
• Centralized Documentation-Access from Anywhere.
• Resolve document issues faster.
• Ability to search documents in many ways.
• Dramatic Reduction in the need to print, scan, and store multiple copies in several locations.
• Link documents together to create a complete document package.
We have been serving eTMF customers since 2007.
Email now to schedule a demonstration and see how Clireo and Arivis can help you with your eTMF needs.
Tricia McQuarrie
Clinical Operations Manager tricia.mcquarrie@arivis.com
Arivis, Inc.
2198 E. Camelback Road
Phoenix, AZ 85016
Tel. 602-957-2150
www.m3.arivis.com
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.
Review of essential documents (TMF BABE).Piyush Wagh
This ppt is useful for the Clinical Auditors (BABE), it helps in reviewing of essential documents and compilation of essential documents during clinical phase. Bioequivalence
Essential Regulatory Documents in Clinical TrialsTrialJoin
The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc.
Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
Clinical Data Management Interview question Part II.ClinosolIndia
The guide emphasizes the importance of understanding the fundamental principles of CDM and provides practical examples and scenarios to help you demonstrate your expertise and problem-solving skills. It also offers guidance on how to showcase your knowledge of industry regulations and guidelines, such as Good Clinical Data Management Practices (GCDMP) and Good Clinical Practice (GCP).
By familiarizing yourself with the interview questions and utilizing the suggested strategies and tips provided, you will be well-prepared to articulate your knowledge, skills, and experience in CDM during your interviews. This resource aims to enhance your interview performance and increase your chances of securing a position in the competitive field of Clinical Data Management.
Whether you are applying for a CDM role in a pharmaceutical company, contract research organization (CRO), or academic institution, CDM Interview Question Part I is an invaluable tool to help you navigate the interview process and stand out as a strong candidate.
Argus Screen Shots General Tab - Katalyst HLSKatalyst HLS
Introduction to Argus Screen Shots General Tab - Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Explaining the Importance of Feasibility Questionnaires and Site Selection Vi...TrialJoin
No matter if you’re reading this because you aspire to become a CRA, or you’re a study coordinator, or maybe you’re part of a research site, learning about feasibility surveys and questionnaires is important for everyone that’s in any way involved in clinical trials.
In this article, we’ll try to explain to you why feasibility questionnaires and site selection visits are important and how they can affect the sponsor’s decision of awarding you the study.
Clireo eTMF Solution by Arivis
What is Clireo?
• Comprehensive Software and Service enabling the Trial Master File
• Compliant with the DIA Trial Master File Reference Model Version 3
• Assign access and maintain control of Sites, Vendors, and Auditors for content.
• Eliminate CRA need to reconcile the Investigator Site File against the Sponsor TMF.
• Part 21 CFR 11 Digital signatures allow for faster turn around time on documents.
• Ability to quickly disseminate new information to users that the information is relevant to.
• Vendors and Sites can upload documentation and data directly into Clireo.
• Unlimited storage capacity assures that all documentation can be held in one location.
• No additional hardware required to implement.
• Dashboard reports on the status of sites and documents to easily identify missing or lagging information.
• Protect documents against unauthorized modification.
• Supports single or multiple file uploads with single screen metadata tagging.
• Centralized Documentation-Access from Anywhere.
• Resolve document issues faster.
• Ability to search documents in many ways.
• Dramatic Reduction in the need to print, scan, and store multiple copies in several locations.
• Link documents together to create a complete document package.
We have been serving eTMF customers since 2007.
Email now to schedule a demonstration and see how Clireo and Arivis can help you with your eTMF needs.
Tricia McQuarrie
Clinical Operations Manager tricia.mcquarrie@arivis.com
Arivis, Inc.
2198 E. Camelback Road
Phoenix, AZ 85016
Tel. 602-957-2150
www.m3.arivis.com
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.
Integrating and appling tmf regulation into your buisness processMontrium
How will you navigate the new TMF regulatory landscape?
Many organizations today still struggle to develop effective compliance strategies. In recent years we have seen a dramatic change in pace from regulatory authorities and standards organizations. With a wealth of new updates coming in, it is becoming increasingly more complex to remain compliant. With this in mind, our upcoming webinar will focus on the recent regulatory changes that will impact trial master files and provide a practical outlook on how to apply them and stay one step ahead.
The objectives of this chapter are to describe the different types of documen...MohamedIFADA
The objectives of this chapter are to describe the different types of
documentation that may have to be produced for large software systems
and to present guidelines for producing high-quality documents. When you
have read the chapter, you will:
understand why it is important to produce some system documentation,
even when agile methods are used for system development;
understand the standards that are important for document production;
have been introduced to the process of professional document
production.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
2. The sponsor and the investigator shall keep a clinical trial master
file. The clinical trial master file shall at all times contain the
essential documents relating to that clinical trial which allow
verification of the conduct of a clinical trial and the quality of the
data generated […]. It shall be readily available, and directly
accessible upon request, to the Member States.
[EU Regulation 536/2014]
3. Essential documents are those documents that individually
and collectively permit evaluation of the conduct of a trial
and the quality of the data produced. These documents
serve to demonstrate the compliance of the investigator,
sponsor, and monitor with the standards of GCP and with
all applicable regulatory requirements.
[ICH GCP, Section 8.1]
4. ICH GCP Section 8.2 – 8.4
“The minimum list of essential documents that has been
developed.....”
ICH GCP does NOT provide a comprehensive contents list for
the TMF
◦ Examples of missing documentation:
Electronic systems
Data management and statistical methodology
Safety monitoring
5. Gap in Electronic Document
Management (EDM) Reference
Model identified for non-
submission TMF documents
EDM scope is regulatory
submissions:
◦ Significant input to the EDM
Reference Model is TMF
Documents
◦ Hence the creation of the TMF
Reference Model
5
DIA Communities
Document & Records
Management Community
• EDM Reference Model
6. Other business records
Supporting files e.g.
computer SDLC files; GMP
manufacturing files; vendor
selection files
Usually
considered
outside the
scope of the
TMF
Other trial-related
records that “permit
evaluation of the
conduct of the trial and
quality of data
produced”
Minimum list of essential
documents, as defined by
ICH GCP, Chapter 8
The Trial Master File
7. Standardizes company content and structure and limits
company customization
◦ We all follow the same regulatory requirements
◦ Inspectors are the same across companies
◦ Company-specific requirements are often driven by tradition, legacy or
personal opinion
Simplifies engagement of CROs and other third parties
Simplifies consolidation of disparate documents into a single
TMF structure (in real time, at defined trial events and/or at
study end)
7
8. Managed by a Steering Committee of 14 members
Change Control Board
Extended Group of over 700 members
June 2010:
Version
1.0- 11
zones w/
associated
artifacts
Feb 2011:
Version
1.1-
Regulator
feedback
Nov 2011:
Version 1.2-
Investigator
Site File and
1st Intro slide
set
June 2012: Version
2.0- Device,
Process-based
metadata, and IIS
Mar 2009:
1st Meeting
~Dec 2012: Kick-
off of many Work
Groups that
support the TMF
manage-ment
process
Feb 2014:
Establishment of
the TMF RM
Steering Committee
June 2015:
Release of
version 3
June 2018:
Release of The
Exchange
Mechanism
8
October
2018:
Release
of
version
3.1
9. 9
Standard Contents
Industry opinion on
what is kept in a TMF
Standard Naming
Based on ICH E6 Sect. 8
& industry-accepted
terminology
Standard Structure
To support paper and
electronic systems
Standard Metadata
For eTMFs, minimum
metadata at system and
artifact level
21
10. Expands minimum list
of documents found in
ICH GCP
Consistent
interpretation, based
on peer opinion and
regulator feedback
Avoids scope creep for
TMF
10
Standard Contents
Industry opinion on
what is kept in a TMF
11. Avoids one artifact
being referred to
using different terms
within an organisation
and between
organisations
Avoids company-
specific terms
11
Standard Naming
Based on ICH E6 Sect. 8
& industry-accepted
terminology
12. Facilitates consistent
filing and rapid retrieval
Helpful when
responsibility for
maintaining different
sections of the TMF is
distributed across
several parties e.g.
sponsor, CRO,
consultants
12
Standard Structure
To support paper and
electronic systems
13. Encourages adoption
of good practices to
facilitate document
retrieval
Encourages
consistency across the
industry for exchange
of content
13
Standard Metadata
For eTMFs, minimum
metadata at system and
artifact level
14. Data held in a simple Excel spreadsheet
◦ Easy for non-technical people to use!
Hierarchical structure
◦ 11 Zones
◦ 48 Sections
◦ 249 Artifacts
14
15. 15
11 Zones
Trial Management
Central Trial Documents
Regulatory
IRB or IEC and other Approvals
Site Management
IP and Trial Supplies
Safety Reporting
Central and Local Testing
Third Parties
Data Management
Statistics
27
16. The contents of
each zone are
grouped into
sections
Each section
includes content
that is relevant to a
specified activity
Sections are helpful
for classification
and searching
16
17. Could include data files, documents, media, digitised content
Could be 1 document or multiple documents
Includes associated records e.g. approvals, translations, checklists, QC records,
amendments
17
18. A description to explain the content of an artifact and/or the use and purpose of
the artifact
Assists with ensuring a common interpretation of the model
Aligned with ICH definitions
18
19. Reference to the ICH GCP Guidelines
Notice that other sections beyond E6 Section 8 are quoted
Includes indirect as well as direct references
19
20. When an artifact name does not explicitly refer to a single kind of record (e.g. Meeting
Material), sub-artifacts provide a means to list all company-specific records that are
expected for a given artifact.
Only examples are provided in the model but expected to be overridden as part of adopting
the Reference Model for a company.
Current subgroup activity to refine
20
21. 21
To create a paper TMF, split the Model out to 3 spreadsheets,
filtering for trial, country and site on each
22. Maintenance release e.g. v3.0.1
◦ e.g. minor typographic changes, clarification, sub-artifacts
Minor release e.g. v3.1
◦ Substantial change in content but no compatibility issues e.g.
additional optional column (milestones)
Major release e.g. v4.0
◦ Change likely to have compatibility issues with prior version e.g.
addition/removal of artifacts
39
23. Documentation Delivered
◦ TMF Reference Model Version 3.1.0
◦ TMF Reference Model Version 3.1.0 Release Notes
Released on 10-Sep-2018 for preview
Effective as of 10-Oct-2018
https://tmfrefmodel.com/resources/
Change Requests ‘By the Numbers’
◦ Total of 64 Change Requests Submitted since October 2015
23 Approved and included in release 3.1.0
18 Rejected
21 Deferred
Deferred to sub-teams, Steering Committee or next release
24. Added deliverables already approved
◦ Suggested dating conventions for each artifact (Feb 2017)
◦ Recommended milestones/events (Jan 2018)
Also scheduled for assessment during 2019 to take account of industry
feedback
25. Four minor changes to artifact name
◦ 03.01.02 Regulatory Approval Notification…. Regulatory Approval
Decision
◦ 03.02.02 Import or Export License…. Import or Export Documentation
◦ 03.03.01 Notification to Regulatory Authority of Safety or Trial
Information…. Notification of Safety or Trial Information
◦ 10.03.10 Data QC or QA Plan and Results…. Data Review
Documentation
26. Eight minor changes to artifact definition/purpose
◦ 01.05.04 Filenote
◦ 02.01.01 Investigator’s Brochure
◦ 03.01.01 Regulatory Submission
◦ 03.03.01 Notification of Safety or Study Information
◦ 06.01.06 IP Transfer Documentation
◦ 08.02.05 Record of Retained Samples
◦ 11.03.02 Analysis QC Documentation
◦ 11.03.09 Final Analysis Datasets
27. Sub-artifacts added for three artifacts
◦ 10.03.09 Dictionary Coding
◦ 10.03.10 Data QC or QA Plan and Results
◦ 02.03.01 Clinical Study Report
Further sub-artifacts currently under development by sub-
artifact team…. for release in 2019
28. Two artifacts with revised ICH codes
◦ To correct a typographical error
◦ 02.01.02 Protocol
◦ 02.01.04 Protocol Amendment
29. Three artifacts with additional filing level
◦ Added study-level:
03.01.01 Regulatory Submission
03.01.02 Regulatory Approval Notification
◦ Added site level:
06.03.02 IP Unblinding Plan
30. Two artifacts with additional alternate names
◦ To correct a typographical error
◦ 03.01.02 Regulatory Authority Decision
◦ 03.02.02 Import or Export Documentation
31. If you have any feedback on the TMF Reference Model,
including comments on existing artifacts, milestones,
suggestions for additional artifacts or general comments
about the TMF Reference Model, please use the link below
to submit your feedback:
https://tmfrefmodel.com/feedback/
32. Use online form for:
• Making a suggestion for a general
enhancement to the Reference Model
• Suggesting a change to any
metadata for an existing artifact
• Suggesting a new artifact
Select the appropriate option and only
make ONE suggestion per form
submitted please.
Do not send general queries using this
form.
33. Have a passion for the TMF? Are you an expert in a
particular area? We are always looking for new
members to join the zone teams!
Follow the instructions on the Join page or contact any
member of the CCB team
34. • Release notes give all details to assess impact
• Minor release so minimal impact on overall structure
• Artifact names may change BUT the artifact numbers do not
change
• Includes process aspects such as milestones and dating
conventions – very customised by Sponsors / CROs
What is the Impact?
35. Minor/Maintenance release anticipated in 1Q 2019
Major release anticipated later in 2019 to incorporate
deliverables from the following sub-teams:
◦ Sub-artifact
◦ Observational and Device
37. Group Aim
Metadata
To standardise the metadata collected – integrated into
the Exchange Mechanism
Sub-artifacts To standardise the subartifacts in the TMF RM
Country specific artifacts
Guide for country specific artifacts required (with links to
relevant websites)
Device Studies Device specific artifacts
JGCP Mapping to Japanese GCP documents
42
38. Join the TMF Reference Model Yahoo! Discussion Group
https://groups.yahoo.com/neo/groups/tmfrefmodel/info
Join the TMF Reference Model Project Team
http://tmfrefmodel.com/join
• Knowledge sharing
• Networking
• Too Much Fun!
QUESTIONS?