Key Issues in Clinical Development for Interventional CV Devices | Page 6

incorrect information while the CRA is off-site. This approach is

Standards for diagnosis also vary across
regions, and sponsors should consider local
requirements for diagnostic testing and/or
imaging and validate radiology and other
technical equipment before study initiation

supported by the FDA as means to improve data quality and
ensure patient protection.9

Key Issue #4: Global Standards of Care »
When conducting multinational trials (or trials in one country
that will be used for regulatory approval in another), it is important
to account for differences in standards of care. Even in device trials,
the use of background medications (eg, statins, blood thinners,
antihypertensives) in one population but not another can impact

In particular, an integrated software platform allows clinical research

the generalizability of results.

associates (CRAs) to perform remote monitoring as soon as a given site
enrolls its first patient. The CRA can track progress, check for errors or

Rates of reported adverse events (AEs) may be affected by cultural

omissions in the data, and generate queries without having to visit the

differences (eg, stoicism, reluctance to complain). Standards for

site. This early look at data can facilitate identification of issues

diagnosis also vary across regions, and sponsors should consider local

(eg, inclusion/exclusion criteria that are too strict, unclear case

requirements for diagnostic testing mand/or imaging and validate

report forms) and enable faster corrective action. In addition, the

radiology and other technical equipment before study initiation.

CRA can assess a site’s performance using pre-specified standards
for screen failure rates, protocol deviations, patient retention, number

Figure 5. Operational Considerations: Partnering with a CRO

of queries, the time required to resolve a query, etc. Based on the
results, the CRA can tailor his/her activities to focus on sites that
need additional training or may require an on-site visit.
The same technology enables risk-based monitoring in which the
need for a site visit is triggered by pre-specified criteria (eg,
accumulation of data, serious adverse event).
During the resulting site visits,
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