eTMF Systems Introduction

Summary

The 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.

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

all right welcome everyone to power of

works presentation on etms systems

so just to kind of give you

an idea that we've been last couple

weeks working on how to qc a document

what you're expecting when you're

looking at a document

and kind of the overall thoughts behind

everything the importance

of

looking at

why tmf is important right so remember

that tmf is trial master file and these

are the documents that are being

collected throughout a clinical study

right and then they're being kind of put

into a folder back in the day this used

to be actually paper document

and they would be physically collected

sometimes mailed in or scanned um and

sent in

but um nowadays it's more

system related

and so today we'll go a little bit on

some overviews about systems and we can

talk about systems and then this is a

part two um

part presentation the second part will

be more about like what to do in a

system and some examples and what you're

looking for

and then

usually when let's say you get a job you

get a tmf job you're gonna have that

company has one system and we'll talk

about that but it might be different but

it's usually very similar work right

um so just as i mentioned

it's usually been historically it's

paper documents and they've been put in

a physical file cabinet and so a lot of

times when i try to describe tmf and

describe um an etmf it's nice to think

of it as a

an actual file folder

and so you can have like a drawer and

then within the drawer um so your drawer

could be like your zone and then you

might have folders and then within your

folders you might have like um kind of

subfolders or tabs within the folder

and that's kind of a good way to think

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

you're trying to get your head around

what is tms right

um and then we found this really cute

little um

image here

that um kind of emphasizes the fact that

it's been hard for a lot of people to

transition to digital

and

we'll talk about the benefits of going

digital but i think this is one reason

why power of work has focused on tms as

kind of our first career um tackle in

terms of helping people gain a really

useful skill

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

there's a lot of people who have a lot

of experience in clinical research but

back in their day

it was all paper so there's not that

many people that have

a tmf skill and are very familiar with

the system a lot of people who have a

lot of experience in clinical research

tend to be older and tend not to have a

lot of technical skills and so they're

usually like less

willing to do tmf

technically because it's a whole new

system to learn so that's why i think

it's kind of a niche a good entry point

because it's needed and it's not as

though everyone has these skills

um and this actually is one way that i

think i kind of broke into this industry

about i think like six or seven years

ago i um was able to get a tmf manager

position um it was actually like a

project manager manager spot but because

i didn't have that much management

experience but i had tmf and i had etm

experience which having that combination

of a little bit of clinical research in

terms of like clinical operations a

little bit of actual knowing how the

system works knowing how like updates

work like a very technical side from it

and then also some like

a little bit of management i think

uh

usually that wouldn't be enough to get

you a management spot but because it was

kind of a niche field and not that many

people had the combination of both

technical and experience with like

clinical research and what tmf was i was

able to get the position and it kind of

kick-started my career

and kind of highlighted the fact that

not that many people actually know

tmf and are technically sappy and want

to do the work right

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

start and um and so that's why i think

it's a good

uh first tackle for power of work

okay so um

yeah so basically

uh before 2009

that it was all just

paper just filing cabins and um we can

have people um from power of work attest

to that that some companies still do

they still have what's called like a tmf

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

not like a library because not as cool

as a library but basically just a room

just filled with um cabinets and in

those cabinets they'll be locked and

kind of protected

but it's a lot harder to find things as

we'll talk about um part of um

as it says here

um as the number of clinical trials

increase it's harder to access audit and

store and submit um so that's kind of

why um

how we're going to actually you know

have an etms system is because there was

a need for it right and so yeah

all right clinical trial documents so as

we talked about there are a lot of

documents in um

running a clinical trial so basically

there are documents from lots of

different functions within the sponsor

company right that's the company

that the sponsor is the person who you

think about like owns the medication a

lot of times there's the ones that

actually have done the research right so

they have like laboratories and they've

done research on this drug and they

think okay now we're ready to

move it to um humans right

or sometimes they've bought the drug

from somebody and they're like okay

we're gonna we're good at writing

clinical trials we'll we'll do this um

but then there's also

a lot of documents that come from the

site which is where the patients are

actually seen

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

they get the drug basically their doctor

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

lot of documents that come from all

different departments and different

aspects right there could be documents

from the site but like from the sites

like um irb or kind of more like

approvals and then there's you know

having to do with let's say a safety

report regarding a certain patient

and then on the sponsor side there could

be a lot of documents in terms of all

these different departments that support

how a clinical trial is run in terms of

like did the the drug get to the site

and was it um did it have the correct

temperature the whole time

those kind of aspects so

there's a lot and a lot of documents and

that's why i saw this image here with um

this printer and all these documents

flying everywhere that's kind of how i

imagine it used to be

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

um digital and i'll talk a little bit

more about finding things and how that

has to do with audits but um

in general

you'll hear this a lot in tmf but they

say if it wasn't documented it doesn't

exist and so

um

basically making sure that you have the

document and are able to retrieve the

document is

very very important

okay etms so etmsf is a digital

um filing structure and it's usually in

a cloud space um and then it's

controlled access so you can see who's

accessed it and when and that way it's

good for an audit

right so that's one aspect of

uh having a filing cabinet system where

you might have a track for who's got

access to the the door but in general

you can't really track who's getting

into what and if you are in terms of

like a lock and key system

it's actually really hard to figure out

not only who had access to what key um

like so you could have like a log where

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

section um this cabinet but that is even

more complicated because if you have a

lock and key section

kind of system set up you have to figure

out like who has the key and it's just

like a lot a lot more work right and

there's also like the physical aspect of

having um a room and then you also have

to have like fire safety for the room

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

easier now to just have it in the cloud

and a lot more secure

and then

there's also like different tools and

strategies that you can use to help

of the clinical trial by having the the

etmf so you can um

like perform your own little audits and

checks are a lot easier within having a

digital system like it's easier to

access

and it's also easier to share access so

for example there's something called a

cro which is your clinical research

organization and that's um a separate

company that really supports clinical

trials in general so most

sponsor companies will hire cro to help

them run their clinical trial just

because there's so many components to

the clinical trial

but if a fiero is helping

and you didn't have an etmf that would

be really difficult in the sense of who

has the documents do all the documents

live with the cro

because if they're keeping a file

structure you want all the documents in

one spot

and so that somebody has to physically

go to the file and like look at the

documents um so it's a lot easier to

share and have different people checking

on their documents

um than it is to have like a room with

paper

um

and then it contains right it's like

software and it helps manage um the

different documents and so um yeah

okay so here are a couple different

um etms and viva vault is a major one

montrium's also smaller one that is

newer and it's not on here yet but um

the the idea that i want to emphasize is

this is that

we can teach you different like basic uh

etms like practices and kind of like

what you do and what you look for uh but

it is really different it's not that

different in a sense um company to

company so it's like if you learn the

basic skills of like okay you're you're

looking at a document how you're playing

a report or how you are trying to get

the data and use the data to

improve the tms

um

you can basically learn these basic

skills that apply to different um

systems right

so

a company usually will only have one of

these unless for example like i

mentioned there's a cro but they've

hired in the crows also managing the tmf

and they've already hired their own but

usually most companies will have okay we

are just doing viva we're just using

trial interactive um so you only have to

really usually learn

one system per like company or like job

right um but it is good to to learn

different systems and so that is

something that i recommend and we can

even try to find um different videos to

show a little bit uh on each system

okay so here are some advantages

so it's easier to find

documents

and that's what we

talked a little bit about right one of

the things for

when you have an audit

is that the idea is that you can pull a

document and by pulling a document and

being able to find a document easily

that means that you guys are that the

company is really doing a good job of

maintaining and

utilizing their documents right so if an

auditor comes in and says

sign me this monitoring report

you can find the monitoring report

because you can go into the system

really easily and and search for the

monitoring report right and if you've

named the document correctly which is

something we've talked about in previous

you want to classify it kind of put it

into the correct folder and you want to

have the correct name

so naming it monitoring report versus

naming it the the confirmation letter

that helps people know and be able to

pull the correct document and

as a result that shows that you're kind

of utilizing your documents you're

running your study well if you can't

find it then to the auditor and this is

let's say this audits from the fda and

you're trying your studies done and

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

this drug it did really well everyone

was happy um it was effective it was

safe and the fda goes okay cool let me

look right

and they'll audit lots of different

aspects but they'll also audit the tms

and that's kind of how how they look at

how the study was run

is based on the document so it's really

important and it's really important that

you're able to find the documents

and that's why

in the past it used to be okay i want

the monitoring report for this one site

somebody would have to go to the room

like open up the drawers find the right

um folder and hope it in the folder it's

there

and and then bring that report over to

the auditor whereas now it's a lot

easier with an etms system because they

can just look it up right

and then you have real-time tracking and

document viewing

so one aspect of

modern etmf world in the auditing

is that when you upload a document

there's a timestamp on it now

so auditors are able to see that you

were maintaining your tmf

nicely like timely that you're making

sure that documents when you when

they're created they're quickly put into

the etms now that's really good if

you're good at your tmf that's not

always the case across the board um but

in general it helps the auditors know

that you were on top of your work

basically um so you can have real-time

access and viewing your documents and

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

just kind of a better system in that

sense like i said it does open up a

potential gap where people it can

highlight where people are doing

something wrong if they're not uploading

their documents in a timely manner but

overall that's just better for everybody

to have it be digital and easily access

now it's reducing auditing um by

making sure that like you can have a a

formal qc aspect so right when you

upload a document and we'll go into this

in a little bit detail in the future so

you upload a document somebody puts in

the metadata and then usually somebody

else will look at it um

and then sometimes it will be a two-step

qc so if

again per the company's policies

but let's say somebody who owns a

document like

somebody from um

a certain department let's say we talked

about

ip shipment that is when the drug gets

sent out to the site

so the from the department of um

clinical supply

they will have a form that shows okay

this is what the drug was sent over and

the temperature was okay right

then they take that document they upload

it into the system

they put the metadata in and so that's

kind of a different department than the

department that runs tmf right so that

would be like the document owner

that that person uploads the document

into the system and then usually the

role of like the tmf team

is somebody looks at the document and

make sure it goes very carefully you

make sure that all the data is correct

and it looks really good um and if it's

not they'll send it back

or they'll have questions or whatnot but

if that looks really good then it'll go

on to a second step that would be a two

qc um

process and then somebody else was in

the tmf team does another look um and

usually at this point everything should

be entered everything should be good

because somebody already looked at it

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

step process and as a result it should

be easy to catch things right

if you had just a paper system and you

had somebody who was just putting the

document in

it's really hard there will be really

hard to have a qc

system right like you would have to have

somebody else come in and take a look or

you could say oh i did file that

yesterday can you take a look like it

would be a lot more work if it was just

physically paper

also um back in my day when it was paper

um

[Music]

it was an issue where people would file

their own tmf documents like they would

just be like oh they would just go in

and they would put it in there and then

the tmf team wouldn't really know it's

there um and or people take out

documents so there's definitely more of

a controlled process um

even prior to going digital but that

some gaps in the process can be like

that um so it reduces auditing because

you have a lot more like you have a lot

more security on it and then you're able

to um kind of

have more of a quality control

it's also um

easier to have like

pulling reports from it right you

can't back in the day when it was paper

a lot of times you'd have like excels

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

the name of the document and so that way

you had like that's the only way you

have a tracker of all the documents is

if you had your own

tracker like excel tracker nowadays

because you enter it into the system the

system can output like a report and you

can look and say okay here are all the

documents in my in my folder um for the

study or for the site um so it has a lot

more auditing capabilities

then also one aspect is sop compliance

so sop is standard operating procedures

there's a whole bunch of different like

guidelines

that each company has on how they're

going to do things and it's a lot easier

to maintain this um when it has an etms

system

also a lot of times sometimes people put

their sops in

the etms system so you can like review

it and see um the filing of the sops so

that's another aspect um and then as we

mentioned

almost anything going digital it saves

money right um so there's no more cost

of storing things uh when you have it

all digital there's definitely digital

costs of course but um overall it's a

cost saving

and then as i mentioned earlier the easy

collaboration with the sites in the cro

you can have multiple people having

access and they don't have to physically

be there to look at the documents

okay this is a little blurry um i whoops

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

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

you a better image um i tried to make it

larger and didn't quite help but

basically i wanted to give you a quick

kind of overview and

little like

sneak peek into the system um

we'll go into deeper detail in the

future

but basically i want you to get if it if

this is such like a foreign concept it's

kind of nice to have a little idea of

what you would see

so this is a screenshot from an etmf

system

and you can see that you have your

document here

and your metadata on the right a lot of

times this is how they're set up and

you'll have different features up here

and different like there's a gear wheel

that lets you do it a lot of different

aspects but the basic

aspect is that you have your document

you can scroll and view your document

and then your metadata is here so your

name type um

your document number if you can have

like kind of um and so you can see here

last modified by that's an advantage of

an html system is that you can have that

record right who's actually who's the

last person to touch the document who

uploaded the document when they uploaded

it

that's a lot of um that is nicely

captured and like the control is really

nice within an etm of system versus

paper

but just to walk you through so if you

are somebody

we gave the example of somebody um from

a drug supply uploading um a document

but let's say

you're you just started a new tmf job

and um and this would be kind of rare

but let's say they still have paper

documents and so your job was to upload

a whole bunch of documents and make sure

the metadata is entered and so you'd

have a big stack of paper you'd scan it

and then you know the digital version

would now be in your computer

and you upload it and then when you

upload it you would check that the

document digital is the correct match

against the document that you have

physically in front of you right so you

make sure

um one of the aspects that we talked

about

previously is you make sure all the

pages are there did you actually put a

giant

stack of like a you know protocol which

is a large document and so let's say

there's like 60 pages

do you scan it and by accident because

it's a double page double-sided document

you only really caught pages one three

five like you only captured the odds so

that's like one of your first checks

that you're looking for is the document

complete

is the digital version a correct match

of the paper version

and then you can look at like what is

the document um so this is an sop but um

you could look at you know making sure

you understand okay what is the document

and does it where does it belong right

um so we talked a little bit about

uh the different filing structures right

and so there's documents that can be at

the study level

country level which is common if you

have like let's say a global study where

you have lots of different countries so

that's something that um kind of helps

you separate out the different documents

that are special per country

if it's like a global study

and then you have your site level which

is where a lot of the the

a lot of the work is at the site just

because there's a lot of sites

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

uh you have a global study and let's say

there's like five different countries

but

within each country there might be like

20 different sites per country right so

a lot of documents would reside at the

site level

and a lot of times when we go over

things here at power of work because um

the site level is a little bit more

standard

and there's a lot of different documents

to look at we're going to really focus

on the site level

and

so you would figure out where does this

document belong like where does it take

place within the the structure and

that's why i keep kind of highlighting

that

knowing your documents and knowing your

tmf reference model which is that um

kind of filing guidelines that you use

to file the documents is really useful

like it's really helpful to know your

documents

and then you kind of figure out all

these different aspects of um what other

metadata you want to enter right so

in aviva system usually you upload it

and it'll have one of the first things

you do is you talk about like where

where you file it what's the artifact

and so um you will kind of from a drop

down poll what folder you basically want

to be in

some utmf systems have a lot of like

auto naming so

you're telling it what folder you want

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

level document and it's a certain um

document that belongs at the site and

let's say like we talked about like

monitoring reports right and so you'll

have the drop down and you'll work with

the system to put it in the correct

folder and then it will kind of auto

name that so it kind of gives that um

kind of like your file structure like

let's say you're filing something on

your computer and you want you have

something in your documents and then you

have another folder within your

documents let's say you call it like

your homework um and then that way if

you look there's kind of like a um

a little a code in the sense of where

exactly the document is and it'll say

like oh um documents

um slash homework or slash right so it's

kind of where you're filing it

and then um

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

have its own viva number um and so

that's easy for you to find it in the

future and if you download a report

sometimes it'll have a link that you can

click

on and then um and then there's other

different aspects to it sometimes um

here it'll show like what what life

cycle it's in

um and then also it will show um

as we mentioned like who touched the

document last like who's been in the

system

but for example if it's related to a

person like a site personnel you

sometimes will actually have a drop down

of

what um what like doctor is on the site

and so you could drop down okay this is

a pi and this is his um financial

disclosure form and if you have that

drop down um you're just tying more

metadata to the document

and so that's one reason why

etms systems a lot better

is because it can kind of help organize

the information and then you can also

help have better reports as you're

searching for different aspects right

um so yeah there's i just want to give

you a little overview on what you'd

expect when you're looking at a document

and then a little introduction to like

what a tmf is and what you would kind of

expect to see

um

within a tmf and then later hopefully

next week we will go over a little bit

more detail about like running a report

and kind of walking through the steps of

what you see um when you're uploading

and going through a tms

and so yeah

please let me know if you have any

questions and we will have a q a

tomorrow so if you have any questions

make sure you write them down you can

email me in advance and we can go

through any aspects