The document discusses factors to consider when selecting electronic data capture (EDC) tools for a clinical trial. It recommends determining the budget based on a cost-benefit analysis of the EDC system's functionality versus study needs. User acceptance is also key, and the vendor should provide usability testing results. Users will need good support from the vendor, sponsor, or contract research organization. Successful implementation requires strong leadership, management skills, and positive attitudes to facilitate change. Careful planning of current and revised processes is important but often overlooked. The EDC system should integrate with a purely electronic clinical trial environment.

1. Selecting
ELECTRONIC DATA CAPTURE
tools

2. Budget
Before any study gets underway, a budget is deter-
mined which includes costs for technology. Deter-
mine your budget for EDC system keeping in mind
that there are EDC systems which allow for a
pay-as-you-go option
Determining the EDC budget should be based on a
cost-benefit analysis of the EDC system’s functional-
ities versus the study’s needs.

3. User acceptance
Usability and flexibility of the system are key fac-
tors to ensure that both the site personnel and
in-house staff are positive and accepting of the
tools. The vendor should be able to provide usabil-
ity testing and user acceptance results

4. User support
Users in house and at the investigative site need a
good support system. Support may be provided
by the vendor, the sponsor, a CRO, or a combination
of two or three of them

5. Successful implementation of
ELECTRONIC DATA CAPTURE
in your clinical trial

6. Leadership
Implementing EDC requires change management;
processes and jobs must change. There are always
those who welcome new ways to achieve their
goals and those who are more comfortable with
the way they have always done their work.
Strong leadership, management skills, and posi-
tive, open attitudes are essential to a successful
implementation.

7. Planning
The planning part of a project is often
short-changed because of timelines, but it is an ex-
tremely important stage. The current process
should be mapped out, then revised according to
the new process using EDC. That also helps pre-
pare for a means to measure the impact of the
EDC. Too often, the baseline for comparison is in-
adequate, which makes it

8. eClinical trials
Ensure that the EDC system fits into a pure eClini-
cal trial environment. That is, make certain that it
supports data interchange standards, allows the
collection of eSource data, and is positioned to fit
into a continuum of primarily electronic processes
and applications for an entire clinical trial.

9. Revolutionary Electronic Data Capture system for clinical trials
Source: BioExecutive International
START YOUR FREE TRIAL
at www.clearclinica.com