The document discusses electronic Trial Master File (eTMF) systems. It defines an eTMF as a formal way to organize and store documents and files required by regulatory agencies for clinical trials. eTMF systems can facilitate efficiencies in trials through improved document collection and management. The key to implementing interoperable eTMF systems is using standards-based models, vocabularies, and web technologies. DBI's cloud-based eTMF platform provides real-time access to clinical documents throughout a trial. Their flat rate licensing fee helps maintain budgets and allows flexibility.

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Benefits of eTMF Systems

2. What is an eTMF?
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An Electronic Trial Master File (eTMF) is a formalized
means of organizing and storing documents, images
and other digital content for clinical trials that may be
required for compliance with government regulatory
agencies.
A well-designed eTMF can facilitate efficiencies in trial
start up, document collection, management and
analysis.

3. Why Are eTMF Systems Important?
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Adoption of electronic document management
processes is becoming essential to business
productivity, cost savings and shortened product
development timelines.
The key to implementation of interoperable eTMF
systems is use of a standards-based content model, a
standards based vocabulary, and web standards-
based technologies.

4. How Can DBI Help?
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DBI’s cloud based eTMF platform gives study team
members real-time access to clinical documents at
every point in a trial's set-up, execution and archival.
Our Flat Rate Licensing Fee helps maintain the budget
while enabling flexibility for the possibility of mid-
study changes.

5. Why ATOMS eTMF?
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 Integrates seamlessly with all other modules within ATOMS
platform
 21 CFR Part 11 compliant
 Utilizes standardized naming conventions both at the folder
and file level
 Folder structure is permission based, meaning users can only
see/access certain documents
 Rights based meaning full control of who has the ability to
upload, download, or administer documents

6. Why ATOMS eTMF? (continued)
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 Reviewer functionality to allow setup of a document review
process flow
 The reviewer function allows notifications to reviewers either
by group or in a set order when it is their time to review a
document
 Allows for electronic signatures of documents
 Allows for FTP access in order to copy an existing structure
or set of folders with files

7. ATOMS’ Features
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 Utilizes xcopy technology that allows the copying of a folder
structure but leaves out any files that exist within
 Availability of an eTMF manager that reviews document on an
ongoing basis to ensure correct document filing
 Ability to set up alerts when documents will expire
 Can house any file type
 Document checkout

8. ATOMS’ Features (Continued)
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 Document checkout
 Archive feature for documents with the same name located
within the same folder
 Place holder for Study, Country, and Site Level folders
 Search for documents by name, documents within a folder, or
documents that contain certain text within them
 Uploading of multiple documents at one time

9. If you have additional questions regarding this
slide presentation or anything else related to
compliant systems, please email us at
partners@dbintegrations.com.
We are here as a resource and happy to provide
any additional information or insight.
office (678) 829-1354
e-fax (678) 807-1905
www.dbintegrations.com

10. If you have additional questions regarding this
slide presentation or anything else related to
compliant systems, please email us at
partners@dbintegrations.com.
We are here as a resource and happy to provide
any additional information or insight.
office (678) 829-1354
e-fax (678) 807-1905
www.dbintegrations.com