Copyright © 2021 pepgra. All rights reserved 1

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

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 in-

house 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

Copyright © 2021 pepgra. All rights reserved 2

preparing is required for clinical research

monitoring.

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

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.

III. PERFORMING EDC IN CLINICAL

TRIALS

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,

Copyright © 2021 pepgra. All rights reserved 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

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. Sahoo, U., & Bhatt, A. (2004). Electronic data capture

(EDC)–a new mantra for clinical trials. Quality

Assurance, 10(3-4), 117-121.

2. 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.