eTMF Systems Introduction

Power of Work
1 Apr 202226:05

Summary

TLDRThe transcript outlines a presentation on Electronic Trial Master File (ETMF) systems, emphasizing the transition from paper documents to digital systems. It highlights the importance of TMF in clinical studies, the benefits of digitalization, and the need for skilled professionals in this niche field. The presentation also discusses the structure of ETMF systems, the advantages of using them, such as improved document accessibility, real-time tracking, and compliance with standard operating procedures (SOPs), and provides insights into the career opportunities in TMF management.

Takeaways

  • 📂 The Trial Master File (TMF) is a collection of documents gathered throughout a clinical study, traditionally managed through paper documents but now transitioning to digital systems known as eTMFs.
  • 🔄 The shift from paper to digital documents in clinical trials has been challenging for some, but it is essential for efficiency and modernization of the TMF process.
  • 💡 eTMFs offer controlled access, real-time tracking, and document versioning, which are crucial for audits and maintaining compliance with regulatory standards.
  • 📈 The digitalization of TMFs has significantly improved the ability to find and retrieve documents, a critical aspect during audits by regulatory bodies like the FDA.
  • 🛠️ eTMF systems streamline the quality control (QC) process, allowing for more efficient document management and reducing the likelihood of errors or discrepancies.
  • 📊 Transitioning to eTMFs has made it easier to generate reports and maintain standard operating procedures (SOPs), enhancing overall compliance and operational efficiency.
  • 🌐 Collaboration among different stakeholders, such as sponsor companies, sites, and clinical research organizations (CROs), is simplified through eTMFs, as they provide a centralized and accessible platform for document management.
  • 💰 The move to eTMFs results in cost savings by eliminating the need for physical storage and reducing the labor associated with manual document handling.
  • 🔍 Familiarity with various eTMF systems is beneficial, as different companies may use different platforms, but the basic skills required for effective TMF management are transferable across systems.
  • 📝 When uploading documents to an eTMF system, it is important to ensure that the digital version matches the paper version, and that all metadata is accurately entered for proper organization and future retrieval.

Q & A

  • What is a Trial Master File (TMF)?

    -A Trial Master File (TMF) is a collection of documents that are gathered throughout a clinical study and are used to maintain a comprehensive record of the trial's progress, data, and regulatory compliance.

  • How have TMFs evolved over time?

    -Historically, TMFs were composed of paper documents that were physically collected and stored in file cabinets. However, with advancements in technology, TMFs have transitioned to electronic formats, known as eTMFs, which are now stored in digital systems or the cloud for easier access, management, and collaboration.

  • Why is the transition to digital TMFs (eTMFs) important?

    -The transition to eTMFs is important because it simplifies the process of document management, retrieval, and sharing. It also enhances the ability to perform audits, maintain compliance with regulatory standards, and reduces costs associated with physical storage. Additionally, it improves the efficiency and accuracy of clinical trials.

  • What are some challenges faced by professionals when transitioning from paper-based TMFs to eTMFs?

    -Some professionals, especially those who are less technically inclined or older, may find it challenging to adapt to the new digital systems. This is because they need to learn new technical skills and adjust to a different way of managing documents, which can be a significant change from their previous experience with paper-based TMFs.

  • What is an Electronic Trial Master File (eTMF) system?

    -An eTMF system is a digital filing structure that is usually hosted in a cloud space. It provides controlled access to documents, allowing for tracking of who accesses the documents and when, which is crucial for audits and maintaining regulatory compliance.

  • What are some benefits of using an eTMF system?

    -Benefits of using an eTMF system include easier document retrieval, real-time tracking and document viewing, enhanced quality control through a formal QC process, improved auditing capabilities, cost savings from reduced physical storage, and easier collaboration with sites and clinical research organizations (CROs).

  • How do eTMF systems support Standard Operating Procedures (SOPs) compliance?

    -eTMF systems support SOPs compliance by providing a structured environment for storing and accessing SOPs, ensuring that they are up-to-date and readily available for review. This helps companies maintain consistent procedures across different departments and trial sites.

  • What is the process of uploading a document to an eTMF system?

    -The process typically involves scanning a paper document to create a digital version, verifying that the digital version matches the paper document, and then uploading it into the appropriate folder within the eTMF system. Metadata, such as document type, document number, and the name of the person who uploaded it, is also entered to facilitate future retrieval and tracking.

  • How do eTMF systems facilitate quality control (QC) of documents?

    -eTMF systems facilitate QC by allowing multiple levels of review. After a document is uploaded and the initial metadata is entered, one person may review the document for accuracy and completeness. If necessary, a second person can perform an additional QC check to ensure that all data is correct and the document is properly formatted and filed.

  • What is the role of a TMF manager in the context of eTMF systems?

    -A TMF manager is responsible for overseeing the maintenance and management of the eTMF system. This includes ensuring that all documents are correctly uploaded, that metadata is accurately entered, and that the system is used effectively to support the clinical trial process. The TMF manager may also be involved in training staff on the use of the eTMF system and ensuring compliance with regulatory requirements.

  • How do eTMF systems support collaboration between different stakeholders in a clinical trial?

    -eTMF systems support collaboration by allowing multiple stakeholders, such as sponsor companies, CROs, and trial sites, to access the same documents and information. This real-time access enables efficient communication,减少了文档的查找和共享的时间,提高了整个临床试验的效率。

Outlines

00:00

📚 Introduction to ETMF Systems and TMF Importance

The video begins with a welcome to a presentation on ETMF (Electronic Trial Master File) systems. It discusses the recent focus on quality control (QC) of documents in clinical studies and the importance of TMF (Trial Master File). Historically, TMFs were paper documents stored physically, but modern systems have transitioned to digital formats. The presentation aims to provide an overview of ETMF systems and their benefits, such as improved organization and accessibility of clinical trial documents. It also highlights the shift in the industry towards digital systems and the need for professionals skilled in managing these systems, emphasizing the value of TMF skills in career development within the clinical research field.

05:00

📈 Evolution of Clinical Trial Document Management

This paragraph delves into the evolution of managing clinical trial documents, noting the increase in complexity as the number of trials grows. It explains the transition from physical filing cabinets to ETMF systems, which are digital filing structures hosted in cloud spaces with controlled access. The benefits of ETMF systems include easier document retrieval, real-time tracking, and compliance with standard operating procedures (SOPs). The paragraph also touches on the advantages of ETMF systems for audits, such as the ability to timestamp document uploads and the ease of sharing documents among different stakeholders like CROs (Clinical Research Organizations).

10:04

🛠️ Learning ETMF Systems and Their Versatility

The speaker emphasizes the adaptability of learning ETMF systems, noting that while each company may use a specific system, the basic skills required are transferable across different platforms. The presentation aims to teach these fundamental skills, which can be applied to various ETMF systems. It also mentions the importance of understanding the structure and organization of documents within these systems, as well as the potential for the presenter to provide additional resources on different ETMF systems.

15:05

🔎 Advantages of ETMF Systems in Document Management

This section highlights the advantages of ETMF systems in managing clinical trial documents. It covers the ease of finding documents, the significance of this for audits, real-time tracking and document viewing, and the improved quality control through a two-step QC process. The paragraph also discusses the reduction in auditing efforts due to the secure nature of ETMF systems and the ability to generate reports directly from the system. Additionally, it touches on the cost-saving aspect of going digital and the ease of collaboration between sites and CROs.

20:07

📂 Uploading Documents and Metadata Entry in ETMF Systems

The paragraph describes the process of uploading documents into an ETMF system and the importance of entering accurate metadata. It provides a hypothetical scenario where a new TMF employee is tasked with digitizing paper documents and ensuring they match their physical counterparts. The process involves checking the completeness of the document, understanding its content, and correctly filing it within the system's structure. The paragraph also explains how metadata is entered, such as the document's type, artifact, folder location, and any specific identifiers like site personnel or study-related details.

25:08

📝 Overview of Document Management and ETMF Systems

The final paragraph provides a brief overview of what to expect when working with ETMF systems and managing TMF documents. It encourages viewers to gain a solid understanding of the documents and the TMF reference model for effective organization and retrieval. The speaker also mentions future discussions on running reports and the steps involved in uploading and managing documents within an ETMF system. The paragraph concludes with an invitation for questions and a reminder about a scheduled Q&A session.

Mindmap

Keywords

💡Trial Master File (TMF)

The Trial Master File (TMF) refers to the collection of documents and records that are compiled throughout a clinical study. These documents are crucial for tracking the progress of the trial, ensuring compliance with regulations, and supporting the marketing authorization of new treatments. In the context of the video, the importance of TMF is emphasized as it is a central component of clinical research and is transitioning from paper-based to digital systems, which is a significant change in the industry.

💡Electronic Trial Master File (eTMF)

An Electronic Trial Master File (eTMF) is a digital system used to manage, store, and track the documents and records associated with clinical trials. This system offers numerous advantages over traditional paper-based TMFs, such as improved accessibility, real-time tracking, and enhanced security. The transition to eTMF is highlighted in the video as a key development in the field of clinical research, making the process more efficient and compliant with regulatory requirements.

💡Quality Control (QC)

Quality Control (QC) refers to the process of ensuring that the documents and data within the TMF are accurate, complete, and in compliance with the required standards. In the context of the video, QC is an essential part of managing the TMF or eTMF, as it helps maintain the integrity of the clinical trial data and ensures that the trial can be successfully audited and approved by regulatory bodies.

💡Standard Operating Procedures (SOPs)

Standard Operating Procedures (SOPs) are detailed, written instructions that outline the steps to be taken for a particular task or process within an organization. In the context of clinical trials and TMF management, SOPs provide guidelines for how to handle, store, and maintain the documents in a way that ensures compliance with regulatory standards. SOPs are crucial for consistency and quality control in clinical research.

💡Clinical Research Organizations (CROs)

Clinical Research Organizations (CROs) are separate companies that specialize in supporting the conduct of clinical trials. They provide a range of services, from designing and executing the trial to managing the data and regulatory submissions. In the context of the video, CROs work in collaboration with sponsor companies to help manage the complex process of running clinical trials, including the management of the TMF or eTMF.

💡Document Management

Document management refers to the process of creating, collecting, storing, and managing the documents and records associated with a project or, in this case, a clinical trial. Effective document management is critical in clinical research to ensure that all necessary information is readily available, organized, and easily retrievable. This is particularly important for regulatory compliance, trial transparency, and the overall success of the clinical trial.

💡Audits

Audits in the context of clinical trials are systematic examinations conducted by regulatory authorities or internal teams to assess whether the trial is being conducted, managed, and recorded in accordance with the agreed protocol, regulations, and guidelines. Audits help ensure the integrity of the data and the overall quality of the clinical trial process. The ability to easily retrieve and review documents is crucial for a successful audit.

💡Cloud Storage

Cloud storage is a digital storage method that allows users to store and access data and files over the internet, rather than on local servers or personal devices. In the context of eTMF systems, cloud storage provides a secure, accessible, and scalable solution for managing clinical trial documents, enabling real-time collaboration and efficient document retrieval.

💡Metadata

Metadata is data that provides information about other data. In the context of document management, metadata refers to the descriptive information that is associated with a document, such as the document's title, author, creation date, and file type. Metadata is essential for organizing, searching, and managing documents within an eTMF system, as it allows for efficient retrieval and understanding of the document's content and context.

💡Training

Training in the context of the video refers to the process of teaching individuals the necessary skills and knowledge to effectively manage and operate eTMF systems. As the clinical research field transitions from paper-based to digital document management, there is a growing need for professionals who are skilled in using these new technologies. Providing training ensures that individuals are equipped to handle the complexities of digital clinical trial management.

Highlights

Introduction to Trial Master File (TMF) and its importance in clinical studies.

Historical transition from paper documents to digital systems in TMF management.

The role of Electronic Trial Master File (ETMF) systems in modern clinical research.

Challenges faced by experienced researchers in adapting to digital ETMF systems.

Career opportunities in TMF and ETMF for those with a combination of technical and clinical research skills.

The critical need for ETMF systems due to the increasing number of clinical trials and documents.

How ETMF systems improve document accessibility, tracking, and auditing.

The benefits of ETMF systems in terms of cost savings and efficiency.

The structure and organization of documents within an ETMF system.

Importance of proper document naming and metadata for easy retrieval and compliance.

The role of cloud-based ETMF systems in facilitating collaboration and document sharing.

Overview of different ETMF systems like Vivra Vault and Montrium.

The process of uploading documents to an ETMF system and ensuring their accuracy.

The significance of real-time tracking and document viewing in ETMF systems for auditing purposes.

The use of ETMF systems for quality control and report generation.

The importance of SOP compliance and how ETMF systems aid in maintaining standard operating procedures.

Transcripts

play00:03

all right welcome everyone to power of

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works presentation on etms systems

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so just to kind of give you

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an idea that we've been last couple

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weeks working on how to qc a document

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what you're expecting when you're

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looking at a document

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and kind of the overall thoughts behind

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everything the importance

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of

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looking at

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why tmf is important right so remember

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that tmf is trial master file and these

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are the documents that are being

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collected throughout a clinical study

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right and then they're being kind of put

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into a folder back in the day this used

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to be actually paper document

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and they would be physically collected

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sometimes mailed in or scanned um and

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sent in

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but um nowadays it's more

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system related

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and so today we'll go a little bit on

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some overviews about systems and we can

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talk about systems and then this is a

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part two um

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part presentation the second part will

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be more about like what to do in a

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system and some examples and what you're

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looking for

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and then

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usually when let's say you get a job you

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get a tmf job you're gonna have that

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company has one system and we'll talk

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about that but it might be different but

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it's usually very similar work right

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um so just as i mentioned

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it's usually been historically it's

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paper documents and they've been put in

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a physical file cabinet and so a lot of

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times when i try to describe tmf and

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describe um an etmf it's nice to think

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of it as a

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an actual file folder

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and so you can have like a drawer and

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then within the drawer um so your drawer

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could be like your zone and then you

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might have folders and then within your

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folders you might have like um kind of

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subfolders or tabs within the folder

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and that's kind of a good way to think

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of it if you're kind of new to it and

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you're trying to get your head around

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what is tms right

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um and then we found this really cute

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little um

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image here

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that um kind of emphasizes the fact that

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it's been hard for a lot of people to

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transition to digital

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and

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we'll talk about the benefits of going

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digital but i think this is one reason

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why power of work has focused on tms as

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kind of our first career um tackle in

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terms of helping people gain a really

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useful skill

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is because it's a skill that's in need

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there's a lot of people who have a lot

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of experience in clinical research but

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back in their day

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it was all paper so there's not that

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many people that have

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a tmf skill and are very familiar with

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the system a lot of people who have a

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lot of experience in clinical research

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tend to be older and tend not to have a

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lot of technical skills and so they're

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usually like less

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willing to do tmf

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technically because it's a whole new

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system to learn so that's why i think

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it's kind of a niche a good entry point

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because it's needed and it's not as

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though everyone has these skills

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um and this actually is one way that i

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think i kind of broke into this industry

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about i think like six or seven years

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ago i um was able to get a tmf manager

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position um it was actually like a

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project manager manager spot but because

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i didn't have that much management

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experience but i had tmf and i had etm

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experience which having that combination

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of a little bit of clinical research in

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terms of like clinical operations a

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little bit of actual knowing how the

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system works knowing how like updates

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work like a very technical side from it

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and then also some like

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a little bit of management i think

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uh

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usually that wouldn't be enough to get

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you a management spot but because it was

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kind of a niche field and not that many

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people had the combination of both

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technical and experience with like

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clinical research and what tmf was i was

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able to get the position and it kind of

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kick-started my career

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and kind of highlighted the fact that

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not that many people actually know

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tmf and are technically sappy and want

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to do the work right

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um so i do think it's a great career to

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start and um and so that's why i think

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it's a good

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uh first tackle for power of work

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okay so um

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yeah so basically

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uh before 2009

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that it was all just

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paper just filing cabins and um we can

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have people um from power of work attest

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to that that some companies still do

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they still have what's called like a tmf

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room where it's just a room i get like a

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not like a library because not as cool

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as a library but basically just a room

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just filled with um cabinets and in

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those cabinets they'll be locked and

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kind of protected

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but it's a lot harder to find things as

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we'll talk about um part of um

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as it says here

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um as the number of clinical trials

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increase it's harder to access audit and

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store and submit um so that's kind of

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why um

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how we're going to actually you know

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have an etms system is because there was

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a need for it right and so yeah

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all right clinical trial documents so as

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we talked about there are a lot of

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documents in um

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running a clinical trial so basically

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there are documents from lots of

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different functions within the sponsor

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company right that's the company

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that the sponsor is the person who you

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think about like owns the medication a

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lot of times there's the ones that

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actually have done the research right so

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they have like laboratories and they've

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done research on this drug and they

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think okay now we're ready to

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move it to um humans right

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or sometimes they've bought the drug

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from somebody and they're like okay

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we're gonna we're good at writing

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clinical trials we'll we'll do this um

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but then there's also

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a lot of documents that come from the

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site which is where the patients are

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actually seen

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uh and that's when they like let's say

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they get the drug basically their doctor

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and that's called the site so there's a

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lot of documents that come from all

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different departments and different

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aspects right there could be documents

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from the site but like from the sites

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like um irb or kind of more like

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approvals and then there's you know

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having to do with let's say a safety

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report regarding a certain patient

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and then on the sponsor side there could

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be a lot of documents in terms of all

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these different departments that support

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how a clinical trial is run in terms of

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like did the the drug get to the site

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and was it um did it have the correct

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temperature the whole time

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those kind of aspects so

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there's a lot and a lot of documents and

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that's why i saw this image here with um

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this printer and all these documents

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flying everywhere that's kind of how i

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imagine it used to be

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and that's why it's critical now to be

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um digital and i'll talk a little bit

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more about finding things and how that

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has to do with audits but um

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in general

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you'll hear this a lot in tmf but they

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say if it wasn't documented it doesn't

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exist and so

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um

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basically making sure that you have the

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document and are able to retrieve the

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document is

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very very important

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okay etms so etmsf is a digital

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um filing structure and it's usually in

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a cloud space um and then it's

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controlled access so you can see who's

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accessed it and when and that way it's

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good for an audit

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right so that's one aspect of

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uh having a filing cabinet system where

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you might have a track for who's got

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access to the the door but in general

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you can't really track who's getting

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into what and if you are in terms of

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like a lock and key system

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it's actually really hard to figure out

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not only who had access to what key um

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like so you could have like a log where

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you'd be like oh i'm checking out this

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section um this cabinet but that is even

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more complicated because if you have a

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lock and key section

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kind of system set up you have to figure

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out like who has the key and it's just

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like a lot a lot more work right and

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there's also like the physical aspect of

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having um a room and then you also have

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to have like fire safety for the room

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and a lot of other issues so it's a lot

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easier now to just have it in the cloud

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and a lot more secure

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and then

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there's also like different tools and

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strategies that you can use to help

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of the clinical trial by having the the

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etmf so you can um

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like perform your own little audits and

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checks are a lot easier within having a

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digital system like it's easier to

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access

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and it's also easier to share access so

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for example there's something called a

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cro which is your clinical research

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organization and that's um a separate

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company that really supports clinical

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trials in general so most

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sponsor companies will hire cro to help

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them run their clinical trial just

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because there's so many components to

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the clinical trial

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but if a fiero is helping

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and you didn't have an etmf that would

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be really difficult in the sense of who

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has the documents do all the documents

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live with the cro

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because if they're keeping a file

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structure you want all the documents in

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one spot

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and so that somebody has to physically

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go to the file and like look at the

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documents um so it's a lot easier to

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share and have different people checking

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on their documents

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um than it is to have like a room with

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paper

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um

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and then it contains right it's like

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software and it helps manage um the

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different documents and so um yeah

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okay so here are a couple different

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um etms and viva vault is a major one

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montrium's also smaller one that is

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newer and it's not on here yet but um

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the the idea that i want to emphasize is

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this is that

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we can teach you different like basic uh

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etms like practices and kind of like

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what you do and what you look for uh but

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it is really different it's not that

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different in a sense um company to

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company so it's like if you learn the

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basic skills of like okay you're you're

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looking at a document how you're playing

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a report or how you are trying to get

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the data and use the data to

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improve the tms

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um

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you can basically learn these basic

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skills that apply to different um

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systems right

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so

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a company usually will only have one of

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these unless for example like i

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mentioned there's a cro but they've

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hired in the crows also managing the tmf

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and they've already hired their own but

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usually most companies will have okay we

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are just doing viva we're just using

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trial interactive um so you only have to

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really usually learn

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one system per like company or like job

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right um but it is good to to learn

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different systems and so that is

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something that i recommend and we can

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even try to find um different videos to

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show a little bit uh on each system

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okay so here are some advantages

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so it's easier to find

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documents

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and that's what we

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talked a little bit about right one of

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the things for

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when you have an audit

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is that the idea is that you can pull a

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document and by pulling a document and

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being able to find a document easily

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that means that you guys are that the

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company is really doing a good job of

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maintaining and

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utilizing their documents right so if an

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auditor comes in and says

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sign me this monitoring report

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you can find the monitoring report

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because you can go into the system

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really easily and and search for the

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monitoring report right and if you've

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named the document correctly which is

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something we've talked about in previous

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you want to classify it kind of put it

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into the correct folder and you want to

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have the correct name

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so naming it monitoring report versus

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naming it the the confirmation letter

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that helps people know and be able to

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pull the correct document and

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as a result that shows that you're kind

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of utilizing your documents you're

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running your study well if you can't

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find it then to the auditor and this is

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let's say this audits from the fda and

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you're trying your studies done and

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you're trying to say hi i'd like to sell

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this drug it did really well everyone

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was happy um it was effective it was

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safe and the fda goes okay cool let me

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look right

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and they'll audit lots of different

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aspects but they'll also audit the tms

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and that's kind of how how they look at

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how the study was run

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is based on the document so it's really

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important and it's really important that

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you're able to find the documents

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and that's why

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in the past it used to be okay i want

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the monitoring report for this one site

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somebody would have to go to the room

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like open up the drawers find the right

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um folder and hope it in the folder it's

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there

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and and then bring that report over to

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the auditor whereas now it's a lot

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easier with an etms system because they

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can just look it up right

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and then you have real-time tracking and

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document viewing

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so one aspect of

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modern etmf world in the auditing

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is that when you upload a document

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there's a timestamp on it now

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so auditors are able to see that you

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were maintaining your tmf

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nicely like timely that you're making

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sure that documents when you when

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they're created they're quickly put into

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the etms now that's really good if

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you're good at your tmf that's not

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always the case across the board um but

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in general it helps the auditors know

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that you were on top of your work

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basically um so you can have real-time

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access and viewing your documents and

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there's a time stamp on it and so it's

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just kind of a better system in that

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sense like i said it does open up a

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potential gap where people it can

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highlight where people are doing

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something wrong if they're not uploading

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their documents in a timely manner but

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overall that's just better for everybody

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to have it be digital and easily access

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now it's reducing auditing um by

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making sure that like you can have a a

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formal qc aspect so right when you

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upload a document and we'll go into this

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in a little bit detail in the future so

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you upload a document somebody puts in

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the metadata and then usually somebody

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else will look at it um

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and then sometimes it will be a two-step

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qc so if

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again per the company's policies

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but let's say somebody who owns a

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document like

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somebody from um

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a certain department let's say we talked

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about

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ip shipment that is when the drug gets

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sent out to the site

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so the from the department of um

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clinical supply

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they will have a form that shows okay

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this is what the drug was sent over and

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the temperature was okay right

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then they take that document they upload

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it into the system

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they put the metadata in and so that's

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kind of a different department than the

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department that runs tmf right so that

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would be like the document owner

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that that person uploads the document

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into the system and then usually the

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role of like the tmf team

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is somebody looks at the document and

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make sure it goes very carefully you

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make sure that all the data is correct

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and it looks really good um and if it's

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not they'll send it back

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or they'll have questions or whatnot but

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if that looks really good then it'll go

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on to a second step that would be a two

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qc um

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process and then somebody else was in

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the tmf team does another look um and

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usually at this point everything should

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be entered everything should be good

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because somebody already looked at it

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but um so that way you'd have a two qc

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step process and as a result it should

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be easy to catch things right

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if you had just a paper system and you

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had somebody who was just putting the

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document in

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it's really hard there will be really

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hard to have a qc

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system right like you would have to have

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somebody else come in and take a look or

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you could say oh i did file that

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yesterday can you take a look like it

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would be a lot more work if it was just

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physically paper

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also um back in my day when it was paper

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um

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[Music]

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it was an issue where people would file

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their own tmf documents like they would

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just be like oh they would just go in

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and they would put it in there and then

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the tmf team wouldn't really know it's

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there um and or people take out

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documents so there's definitely more of

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a controlled process um

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even prior to going digital but that

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some gaps in the process can be like

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that um so it reduces auditing because

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you have a lot more like you have a lot

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more security on it and then you're able

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to um kind of

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have more of a quality control

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it's also um

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easier to have like

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pulling reports from it right you

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can't back in the day when it was paper

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a lot of times you'd have like excels

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where you'd enter in like you'd enter in

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the name of the document and so that way

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you had like that's the only way you

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have a tracker of all the documents is

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if you had your own

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tracker like excel tracker nowadays

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because you enter it into the system the

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system can output like a report and you

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can look and say okay here are all the

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documents in my in my folder um for the

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study or for the site um so it has a lot

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more auditing capabilities

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then also one aspect is sop compliance

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so sop is standard operating procedures

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there's a whole bunch of different like

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guidelines

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that each company has on how they're

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going to do things and it's a lot easier

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to maintain this um when it has an etms

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system

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also a lot of times sometimes people put

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their sops in

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the etms system so you can like review

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it and see um the filing of the sops so

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that's another aspect um and then as we

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mentioned

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almost anything going digital it saves

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money right um so there's no more cost

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of storing things uh when you have it

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all digital there's definitely digital

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costs of course but um overall it's a

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cost saving

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and then as i mentioned earlier the easy

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collaboration with the sites in the cro

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you can have multiple people having

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access and they don't have to physically

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be there to look at the documents

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okay this is a little blurry um i whoops

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now let's see if i can go back yeah okay

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so sorry it's a little blurry we'll get

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you a better image um i tried to make it

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larger and didn't quite help but

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basically i wanted to give you a quick

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kind of overview and

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little like

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sneak peek into the system um

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we'll go into deeper detail in the

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future

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but basically i want you to get if it if

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this is such like a foreign concept it's

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kind of nice to have a little idea of

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what you would see

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so this is a screenshot from an etmf

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system

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and you can see that you have your

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document here

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and your metadata on the right a lot of

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times this is how they're set up and

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you'll have different features up here

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and different like there's a gear wheel

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that lets you do it a lot of different

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aspects but the basic

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aspect is that you have your document

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you can scroll and view your document

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and then your metadata is here so your

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name type um

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your document number if you can have

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like kind of um and so you can see here

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last modified by that's an advantage of

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an html system is that you can have that

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record right who's actually who's the

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last person to touch the document who

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uploaded the document when they uploaded

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it

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that's a lot of um that is nicely

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captured and like the control is really

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nice within an etm of system versus

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paper

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but just to walk you through so if you

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are somebody

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we gave the example of somebody um from

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a drug supply uploading um a document

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but let's say

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you're you just started a new tmf job

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and um and this would be kind of rare

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but let's say they still have paper

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documents and so your job was to upload

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a whole bunch of documents and make sure

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the metadata is entered and so you'd

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have a big stack of paper you'd scan it

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and then you know the digital version

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would now be in your computer

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and you upload it and then when you

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upload it you would check that the

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document digital is the correct match

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against the document that you have

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physically in front of you right so you

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make sure

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um one of the aspects that we talked

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about

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previously is you make sure all the

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pages are there did you actually put a

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giant

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stack of like a you know protocol which

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is a large document and so let's say

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there's like 60 pages

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do you scan it and by accident because

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it's a double page double-sided document

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you only really caught pages one three

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five like you only captured the odds so

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that's like one of your first checks

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that you're looking for is the document

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complete

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is the digital version a correct match

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of the paper version

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and then you can look at like what is

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the document um so this is an sop but um

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you could look at you know making sure

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you understand okay what is the document

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and does it where does it belong right

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um so we talked a little bit about

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uh the different filing structures right

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and so there's documents that can be at

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the study level

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country level which is common if you

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have like let's say a global study where

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you have lots of different countries so

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that's something that um kind of helps

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you separate out the different documents

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that are special per country

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if it's like a global study

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and then you have your site level which

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is where a lot of the the

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a lot of the work is at the site just

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because there's a lot of sites

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um let's say you know you're at a global

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uh you have a global study and let's say

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there's like five different countries

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but

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within each country there might be like

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20 different sites per country right so

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a lot of documents would reside at the

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site level

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and a lot of times when we go over

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things here at power of work because um

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the site level is a little bit more

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standard

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and there's a lot of different documents

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to look at we're going to really focus

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on the site level

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and

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so you would figure out where does this

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document belong like where does it take

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place within the the structure and

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that's why i keep kind of highlighting

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that

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knowing your documents and knowing your

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tmf reference model which is that um

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kind of filing guidelines that you use

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to file the documents is really useful

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like it's really helpful to know your

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documents

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and then you kind of figure out all

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these different aspects of um what other

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metadata you want to enter right so

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in aviva system usually you upload it

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and it'll have one of the first things

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you do is you talk about like where

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where you file it what's the artifact

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and so um you will kind of from a drop

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down poll what folder you basically want

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to be in

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some utmf systems have a lot of like

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auto naming so

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you're telling it what folder you want

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to be in like let's say it is a site

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level document and it's a certain um

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document that belongs at the site and

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let's say like we talked about like

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monitoring reports right and so you'll

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have the drop down and you'll work with

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the system to put it in the correct

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folder and then it will kind of auto

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name that so it kind of gives that um

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kind of like your file structure like

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let's say you're filing something on

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your computer and you want you have

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something in your documents and then you

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have another folder within your

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documents let's say you call it like

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your homework um and then that way if

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you look there's kind of like a um

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a little a code in the sense of where

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exactly the document is and it'll say

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like oh um documents

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um slash homework or slash right so it's

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kind of where you're filing it

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and then um

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so in this case because it's aviva it'll

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have its own viva number um and so

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that's easy for you to find it in the

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future and if you download a report

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sometimes it'll have a link that you can

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click

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on and then um and then there's other

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different aspects to it sometimes um

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here it'll show like what what life

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cycle it's in

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um and then also it will show um

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as we mentioned like who touched the

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document last like who's been in the

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system

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but for example if it's related to a

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person like a site personnel you

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sometimes will actually have a drop down

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of

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what um what like doctor is on the site

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and so you could drop down okay this is

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a pi and this is his um financial

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disclosure form and if you have that

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drop down um you're just tying more

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metadata to the document

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and so that's one reason why

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etms systems a lot better

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is because it can kind of help organize

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the information and then you can also

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help have better reports as you're

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searching for different aspects right

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um so yeah there's i just want to give

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you a little overview on what you'd

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expect when you're looking at a document

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and then a little introduction to like

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what a tmf is and what you would kind of

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expect to see

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um

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within a tmf and then later hopefully

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next week we will go over a little bit

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more detail about like running a report

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and kind of walking through the steps of

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what you see um when you're uploading

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and going through a tms

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and so yeah

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please let me know if you have any

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questions and we will have a q a

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tomorrow so if you have any questions

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make sure you write them down you can

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email me in advance and we can go

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through any aspects

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