Uses and Implementation Process of Electronic Data Capture (EDC) in
Clinical Trials
Dr. Nancy Agnes, Head,
Technical Operations, Pepgra
Sales.cro@pepgra.com
In-Brief
Clinical Trial Management Systems
(CTMS) are an essential part of every
clinical trial. Choosing the right CTMS
helps address inadequacies on the
operational side of research, such as
clinical trial preparation, planning,
performance and writing for clinical trial
monitoring. As more pharma and
biopharma promoters start to identify the
potential
breaks
with
EDC-CTMS
integration, there is a growing requirement
to address the complicated electronic data
capture (EDC) execution procedure.
Pepgra explains the EDC benefits and
implementation process in this blog and
also offers clinical trial monitoring services
Keywords:
clinical trial monitoring, clinical trial
services, medical monitor responsibilities in
a clinical trial, clinical research
monitoring, clinical site monitoring,
clinical trial audit, clinical trial monitoring
services, clinical trial management, clinical
trial companies, clinical trial monitoring
services, clinical monitoring services
I. INTRODUCTION
An Electronic Data Capture (EDC)
framework is programming that stores
persistent information gathered in clinical
trials to lay it out plainly. Information is
ordinarily first recorded on paper and is then
translated into the framework and saved in
Copyright © 2021 pepgra. All rights reserved
an electronic case report format (CRF). An
ever-increasing number of clinical trials are
taking EDC programming and supplanting
paper records with electronic records.
Supporters, contract research organization
(CROs), and locales have embraced EDC
frameworks to do both straightforward and
complex trials taking all things together
periods of research. While there are
numerous EDC merchants, a few
associations assemble their framework inhouse using clinical trial services. Most
EDC frameworks offer somewhat various
highlights, yet all EDC programming is
intended to smooth out information
assortment.
II. USES OF AN EDC SYSTEM IN
CLINICAL TRIALS
Many research associations understand
EDC's upsides over different techniques and
utilize new medical monitor responsibilities
in a clinical trial. An EDC framework can
assist you with making progress in the
accompanying manners:
Quicker Access to Data
An EDC framework can save a lot of time
with continuous admittance to information
and less time spent on inquiry the board. It
additionally saves time toward the finish of
an
investigation,
permitting
faster
accessibility of the data for examination.
While it can require some investment to at
first figure out how to utilize a particular
framework, some are spontaneous to such an
extent that a couple of long periods of
1
preparing is required for clinical research
monitoring.
proficiency because of its easy to understand
the route. Search choices permit you to
discover and channel precisely what you
need handily and store everything in one
area with more prominent while utilizing
less paper.
Cost-Effectiveness
Monetarily talking, the expense of an EDC
framework goes from free to costly. Valuing
shifts, and a few sellers charge for extra help
and different costs. Buying an EDC
framework can appear to be a huge venture.
However, it should set aside cash over the
long haul.
Compliance
An EDC should be consistent with
administrative prerequisites. The product
ought to have technical controls set up to
guarantee
information
honesty.
To
appropriately keep an EDC framework,
standard operation procedure (SOPs) are
fundamental to ensuring administrative and
hierarchical approaches are met.
Data Security
An EDC framework is facilitated online
with an information section finished on an
electronic interface in the clinical trial audit.
Given the idea of the information gathered
in an EDC framework, programming sellers
ensure the information is secured and
sponsored up. Since every client account has
assigned consents, most activities must be
completed by specific jobs.
Accuracy
EDC frameworks improve information
quality. There are choices to include
limitations in a format that keep erroneous
or strange rates from being entered.
Utilizing
a
modernized
framework
empowers decipherable passages and
programmed counts for cleaner information
using clinical trial monitoring services.
Organization
The utilization of an EDC framework
expands
clinical
trial
management
III. PERFORMING EDC IN CLINICAL
TRIALS
Copyright © 2021 pepgra. All rights reserved
Making the transition to EDC
The appearance of EDC advancements is
molding
the
clinical
preliminaries
information the executive's scene, offering
numerous advantages for the business.
EDC's appropriation instead of paper-based
strategies was initially passive; anyway,
clients can get things done with EDC that
they can't do with standard information
bases, making a solid case for the venture.
The most recent years have seen an
extraordinary move in EDC's take-up with
paper CRFs currently just being considered
for specific prerequisites. Advanced layouts
are handily changed to suit each new
investigation; saving time spent planning
and delivering paper CRFs. On average, it
has been demonstrated that EDC cuts 41%
of pre-study planning time. Utilizing EDC,
2
information is gathered and gone into an
information assortment device just a single
time, with a paper framework; information
should be entered first and foremost into a
case report structure then into an electronic
framework by an information section
gathering. It expands handling time as well
as influences record honesty.
EDC likewise permits information cleaning
to happen promptly and doesn't need
escalated hands-on work from information
the executive's bunch for preparing. The info
the executive's bunch executes the rationale
checks against data gathered weeks or
months back as paper contemplates. EDC
framework rationale checks are conducted
when the site enters and submits
information, permitting it to be cleaned
progressively. At last, following appropriate
framework determination and advancement,
just as excellent examination the executives,
EDC allows clients brisk admittance to clean
information with low operational expenses.
Making a complete EDC data set plan
There is a requirement for interest as
expected and assets to guarantee that every
preliminary information base is exhaustive.
If organizations don't make this venture,
there is a danger that changes, or
increments, will be required later, which will
be exorbitant and could have more extensive
ramifications on tasks.
Most EDC frameworks accompany a
standard set-up of reports; nonetheless, extra
pieces might be needed for study oversight
and the board. Most great EDC merchants
can give additional custom announcing.
Likewise, with the information base turn of
events, the plan of reports must be very
much thought of and indicated toward the
start of the investigation.
Inside the plan of an EDC framework, it is
likewise imperative to consider the
configuration in which information is being
gathered to be genuinely deciphered or
customized in another outsider programming
Copyright © 2021 pepgra. All rights reserved
once it leaves the EDC framework.
Executing a predictable information
assortment
strategy
incorporates
normalizing the definitions for the
information gathered across numerous
destinations.
EDC frameworks should have a choice to
observe Clinical Data Interchange Standards
Consortium (CDISC) principles, and for
datasets to be following Clinical Data
Acquisition
Standards
Harmonization
(CDASH) rules, so it is prepared for factual
examination later on. It can save time and
efficiencies as non-CDASH information
should be re-attempted to satisfy a CDISC
guideline
upon
administrative
accommodation.
The utilization of a more prominent number
of standard plans during study constructs
can assist with proficiency and the nature of
revealing. Yet, it altogether lessens the time
it takes for information bases to be
assembled.
IV. CONCLUSION
As more pharma and biopharma promoters
start to identify the potential breaks with
EDC-CTMS integration, there is a growing
requirement to address the complex
electronic data capture (EDC) execution
procedure and its applications. Pepgra
explains
the
EDC
benefits
and
implementation process in this blog and also
offers clinical monitoring services.
REFERENCES
1.
2.
Sahoo, U., & Bhatt, A. (2004). Electronic data capture
(EDC)–a new mantra for clinical trials. Quality
Assurance, 10(3-4), 117-121.
El Emam, K., Jonker, E., Sampson, M., Krleža-Jerić,
K., & Neisa, A. (2009). The use of electronic data
capture tools in clinical trials: Web-survey of 259
Canadian trials. Journal of medical Internet
research, 11(1), e8.
2