Fusing Specifications and Design

for Data Collection Casebooks

with Veeva Vault EDC

Writing and reviewing stand-alone study specifications is time consuming and can add
weeks or months to the study timeline. Much of the effort and delay results from the
diverse stakeholders. A ten-page requirements document that is appropriate for the
sponsor may translate into a 100+ page technical specification from the CRO or EDC
vendor. And the detailed specification documents needed for clinical programmers
are laborious and challenging for sponsor teams to review. This inherently inefficient
process represents a prime opportunity for technology disruption to deliver significant
time savings. Data Management teams can contribute to shortening timelines by
adopting a modern EDC and reengineering the study build process.

Agile Design is a new approach to building clinical Figure 1. Five Principals of Agile Design.
data collection casebooks. Advances in modern
EDC systems enable you to apply many of the
BUILD
process improvements established with agile
software development to clinical data. Agile Design 1. Fusing Specifications & Design
addresses challenges throughout the traditional 2. Data-driven Rules & Dynamics
build process, from writing specifications, to 3. Real-time & Risk-based UAT
casebook designs and UAT, re-use of standards,
and post-production changes. The technology and
process improvements within Agile Design make EXECUTION
it easy to build complex studies, iterate quickly,
4. Easy Amendments & Changes
and deploy updates, which helps your study team
become nimble and more successful.

RE-USE
5. Standards Library

«1»
V E E VA . C O M
veeva.com Fusing Specifications and Design for Data Collection Casebooks with Veeva Vault EDC
 The first principle of Agile Design is fusing casebook specifications and design into a single step.
Historically, these were separate processes, using separate tools, by separate people. With Vault EDC,
people who have historically defined specifications from a protocol, such as a data manager, now do so
directly within Vault CDMS. As they configure a data collection casebook, they are effectively writing the
spec. The spec and the casebook are created in a single step. And that spec can be distributed in multiple
formats for the study team to review: as a Microsoft Excel™ document, as annotated PDFs, or as the
functioning casebook itself.

Technology advances within Vault EDC enable organizations to configure study casebooks, rules,
and edit checks without the overhead and delay associated with authoring and reviewing the study specs
in Microsoft Word™ and Excel™. Eliminating the need for standalone specs is part of an Agile Design
methodology that reduces study build times and effort by over 50%. This paper describes how creating
the specifications and design in one step, within the EDC, produces greater quality and speed.

Figure 2. Eliminating Standalone Specs Saves Weeks of Time and Effort.

A Traditional Process
Create Specifications Build Database

Spec.

Protocol Design Review Design Review Build Review Modify Review Modify
Study & Test Study & Test Study

B Agile Design
Configure Specifications and Casebook Time Savings

Review Review & Test

Protocol Configure
Study
Modify & Modify
Configure Study

 The protocol is your spec. Everything that needs to be analyzed is in the

protocol. Veeva works from the protocol, just like they would from a spec.
We’re just eliminating a big time consuming step in the middle.
– Vikas Gulati, executive director of clinical data management and metrics, Vertex

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Creating Casebooks Directly from the Protocol
Historically, data managers needed a separate
specifications document to physically hand-off to a
programmer. Most EDC systems are sufficiently complex
Clinical Programmers
as Study Designers
that people need extensive training to build Case Report
Forms (CRFs) and software engineering skills to write edit The technical aptitudes of clinical
checks as custom functions (code that runs outside of the programmers and database developers
span a broad spectrum – from those
EDC). The phrase “building a database” was an accurate
with technical savvy to those with deep
representation of what occurred. And as long as the EDC software programming expertise.
requires a programmer to build a database and write
In most cases, a technically savvy
custom functions, a separate specifications document will clinical programmer or database
be required. developer with knowledge of clinical
trials can configure a complete
In order to fuse specifications and design, the EDC must casebook in Vault EDC, including all
provide an intuitive interface that makes it sufficiently the rules and edit checks, even for
easy to configure casebooks and write edit checks that complex oncology studies running
you no longer need software programmers to do the job. adaptive trials.

Data managers are expert in the data requirements for However, for accuracy and simplicity,
clinical trials and are the most qualified individuals to we use the title study designer since
little-to-no software programming is
design a CRF. EDC technologies should enable these
needed with Vault EDC. The coding of
data managers and study designers with clinical expertise advanced edit checks and custom
to configure studies themselves. See the accompanying functions commonly done for traditional
sidebar for a more complete description of the study EDC systems is rarely needed.
designer role.

The design environment within Vault EDC, named Studio, was conceived as a place for data managers
to specify the data collection requirements of their study. Creating a specification in some other system
or format adds an additional step. Conceptually, building a casebook in Vault EDC is like writing a spec,
only easier because the constructs for data collection are pre-built. There is a drag-and-drop interface for
pulling pre-defined data fields into a case report form and defining the edit checks and other parameters.

Creating Rules and Edit Checks

Veeva has a design principle that spans all products which is to automate simple tasks and make the
hard tasks easy. Applying that principle to rules and edit checks means automating the creation of simple
univariate checks and providing an intuitive user interface to simplify the creation of complex rules.

Automating Simple Checks

Vault EDC uses the properties you’ve entered when defining an item to create system-managed data
validation rules beyond the simple univariate range checks. For example, when configuring the event
schedule, you simply specify the expected date ranges and offsets of planned visits. During the study,
the system automatically checks event schedule dates without anyone programming the validation rules.

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  One of the things I like about Vault EDC compared to other EDCs is the
reduction in edit checks. For example, for typical study you’ll need 20 checks
just to check for future dates. As a CRO building a hundred studies a year, that's
2000 edit checks. And we don't just program, we also validate by writing three
scripts, one each for a future date, a current date, and a past date, just to test
that it's working. With Veeva, future date checks are just a setting, you don't have
to write any scripts.
– Harbal Sidhu, senior manager of clinical data systems, ICON

Simplifying Complex Checks and Rules

A rules engine in Vault EDC performs the edit checks and executes any branching logic, dynamic form
creation, or other tasks specified in your business rules. An intuitive interface for the rules engine makes it
easy for data managers or study designers to create sophisticated edit checks and business rules.

Figure 3. A Script Editor Assists Users with Creating Rules.

1 2 3

Specify Select Specify

the data variables functions desired actions
e.g. Age, blood pressure, e.g. Mathematical, logical, e.g. Placing a calculated result
or sex date/time, or text-based in a designated field, adding
functions a form, or sending an email.

Vault can perform a large variety of tasks based on the rules and entered values, such as:

• Adding or removing events, visits, or forms. For example, adding or removing forms based
on the route of administration.

• Enabling or disabling certain items on a form. For example, disabling questions about
child-bearing potential for patients where sex = male.

• Deriving the value of a related item. For example, calculating a patient’s BMI or returning a
value of true if the tumor size in the second visit is less than the first.

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 Much like Google’s auto-complete for search
terms, Vault provides auto-complete suggestions to
help you write rules. Using the context of existing Case Study
identifiers, variables, and operators Vault intelligently Veeva re-built a study for one customer
suggests appropriate options for your next step. using data-driven rules and dynamics to
A rule can include multiple conditions and actions; replace the 32 treatment cycles and 128 visits
needed in their traditional EDC with a single
for example, if a comparison of tumor sizes indicates
repeating treatment cycle, and three visits
that a tumor has shrunk, automatically add a with dynamic forms in Vault EDC.
new treatment cycle with related visits and forms.
By pairing a powerful rules engine with
The rules engine assists users in writing rules, dynamic visits, forms, and fields, you can
thereby lowering the technical threshold for data configure complex study
managers to become study designers and/or making designs with
your current clinical programmers more productive. relative ease.

Veeva's goal is to eliminate the need for custom

functions and other forms of external code. Every
time a study needs a custom function (called
triggers within Vault EDC) the product team adds
that functional gap as a feature request for a future
release. This approach has greatly reduced the
128 unique visits 3 dynamic visits
number of custom functions required compared to in legacy EDC in Vault EDC
traditional EDC systems.

Capturing Requirements not in the Protocol

Traditional specification documents provide additional requirements and detail that aren’t mentioned in the
protocol. These are often standard data requirements for an organization that are used across studies.
The best practice within Agile Design is to capture these requirements within the organization’s standards
library or a template study. Vault EDC makes it easy to reuse forms from a prior study, leverage Veeva’s
existing form templates based on the CDISC standard, or ingest the configuration files from prior studies
in Medidata Rave or Oracle InForm. If configuring their own casebooks, sponsors can spec these
requirements directly within Vault EDC, just as they would traditionally do within Excel. When working with
a CRO, sponsors can create smaller topic-based specs for rules or edit checks that are specific to the
therapeutic area or study. Creating these separately, while the casebook is being configured, shortens the
overall development cycle.

 The real difficulty in building a study lies in the edit checks – that’s where you
require a programming background. But that’s not needed with Vault EDC. If you
know how to use Boolean logic and if/then statements, you can write edit checks
in Studio. It is really very intuitive and easy to use.
– Harbal Sidhu, senior manager of clinical data systems, ICON

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 Reviewing the Database for Accuracy and Completeness
Live, interactive design review meetings with the appropriate stakeholders are critical when fusing
specifications and design. In the traditional process, a Word or Excel-based spec is circulated for study
team members to review independently and provide feedback. With a consolidated process, participants
review the actual EDC screens within a
development environment along with annotated
PDFs, a system-generated study specifications
spreadsheet, and differential reports which Higher Quality and Fidelity
to the Protocol
indicate what has changed since the last review.
Team members come together in a room and/ Multiple factors combine to ensure that studies
or via video conferencing and walk through each are reviewed with higher quality and fidelity to the
protocol than those built using standalone specs,
screen. Questions and concerns are openly
these include:
discussed so decisions are made based on the
collective inputs and requirements of the different • Live, cross-functional design reviews and
discussion
teams. Database changes in Vault EDC are
made in real-time. There is no need to push the • Reviewing the actual casebook rather than a
description of the casebook
screens into production for users to see updates.
Seeing each other’s ideas and suggestions • Shared access to the casebook and ongoing
reviews throughout the updates
in real-time directly within the EDC significantly
increases collaboration and helps teams • An equally thorough UAT
consider the implications of different options
and subsequently make better decisions.

Auto-generating the Study Design Specification

Specifications continue to play an important role in documenting the study for compliance purposes and
sponsor sign-offs. In Veeva’s Agile Design process, these specs are auto-generated by the system. Vault
EDC is self-documenting and generates a Study Design Specification (SDS) as a Microsoft Excel™
workbook with separate worksheets for key study design components. Every aspect and attribute of the
data collection casebook is documented, including the study schedule, form definitions, codelists, rules,
and more. The system-generated spec accurately documents each version of the casebook. When post-
production changes are needed, a separate automated report, called the Study Differences Report,
documents all differences between the two versions.

 We have experienced data managers who can read through a protocol and build the
forms and edit checks in Vault CDMS directly. When done, they can push a button to
generate a complete set of specifications, documenting everything you can imagine,
and take that to the sponsor for sign-off.
– Tanya du Plessis, vice president of data strategies, Bioforum

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Conclusion
The Agile Design methodology uses technology to reinvent the old database build process. Eliminating
a standalone spec saves organizations weeks of time spent authoring and reviewing the document.
Many of Veeva's customers provided a traditional spec for their initial studies, but quickly adapted their
process to work straight from the protocol once they saw how easy it is to configure studies in Vault
EDC. Traditional specs are replaced by defining your casebook within Vault EDC. Manual tasks are
greatly reduced—e.g. sponsors provide CROs with only a mini-spec for items outside of the protocol
or standards. While automated tasks are greatly increased—e.g. rules and edit checks are productized
within the rules engine, and a comprehensive spec is system-generated for documentation purposes.
Fusing specifications and design in a single step is one of the ways that Agile Design with Vault EDC
reduces the time and effort to produce new data collection casebooks.

Figure 4. Fusing Specifications and Design to Configure Data Collection Casebooks

in Veeva Vault CDMS.

Casebook,
Protocol Rules,
Edit Checks

PDF

Standards
Annotated
Data Manager eCRFs
or Study Designer

EXCEL

Topic-based specs Comprehensive

per therapeutic area system-generated
if needed study specifications

 Vault EDC is more agile. It provides an environment where you can deliver a lot
faster. You have more capabilities in your forms than people are accustomed to.
We’ve had to stop and rethink how we do builds. The team took a step back and
considered it as a clean slate. We asked ourselves, how would we like to do
builds? It was a great experience and challenge to step outside the box and take
a new approach.
– Tanya du Plessis, vice president of data strategies, Bioforum

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Fulfilling the Functions of a Spec in Agile Design

Common Functions of a Spec Veeva’s Agile Design Approach

Translation – Translating clinical requirements Vault EDC Studio is easy enough to use that experienced data
defined within the protocol for non-clinical managers and study designers can build casebooks and rules
programmers who build the database. directly from your protocol and standards.

Much of the supplemental information about data capture is best

Elaboration – Supplementing the protocol with
codified in company and industry standards. Creating and reusing
additional requirements and detailing how the
standards lessens the need for traditional standalone specs.
data should be collected.
Sponsors working with CROs can provide mini-specs for study-
specific requirements or edit checks.

Cross-functional design reviews during the build process ensure that

the database fulfills study requirements.
Confirmation – Providing a description/check-
list that ensures everything needed gets built. These reviews are equally or more effective than the reviews done
for a spec, because it is easier to evaluate an actual casebook than
a description of what the casebook should look like.

Given the cost and complexity associated with traditional EDC

Global low cost labor locations – Distributing
programming, many organizations move work to locations with lower
the build process across multiple people or to
cost resources. With Studio in Vault EDC, few skilled programmers
offshore resources.
are needed, which reduces the need for lower-cost labor sources.

Using a single metadata definition for specification, design and

execution, eliminates the need to test whether the run-time EDC
meets the specification. The focus and effort spent reviewing
Testing – Provides a description/check-list for standalone specs is redirected to ensure the casebook design is
reviewers to test against, to know you captured correct in the first place.
everything. Testing is focused where it matters most, ensuring the EDC
casebook meets all study requirements. Sponsors create and
provide test scripts based on the protocol and company standards to
ensure study design integrity.

The system-generated Study Design Specification (SDS) provides

thorough documentation of all aspects of the study design and
Compliance – Documenting what was built for database configuration.
compliance purposes and sponsor/CRO sign-offs. The SDS provides a 100% accurate documentation of what was
designed and built. It can be reviewed independently and compared
to the protocol for official compliance and contracting purposes.

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 Common Functions of a Spec Veeva’s Agile Design Approach

Separate project management documents such as the

Project Management – Tracking what's been
Configuration Validation Plan, a Validation Status Tracker, and a
built, what’s outstanding, what's been tested,
Traceability Matrix are used to track which elements and rules are
and more.
complete and which remain to be built.

Vault EDC fosters reuse directly within the system. Easily search
for previously defined forms and fields and drag them into your new
Library – Fostering reuse. Cut and paste edit study with or without their rule definitions.
checks from the specs of prior studies. Run study validation checks to identify potential issues from
copying objects with dependencies, such as crossform
multivariate rules.

About Veeva Systems

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the interests of all stakeholders, including customers, employees, shareholders,
and the industries it serves. For more information, visit veeva.com.

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