Clinical Events Adjudication in the Digital Age | Page 6

However, if the chair’s decision is discordant with
members 1 and 2, event adjudication is deferred to
a committee meeting where the discordant fields are
discussed by all members. This meeting can occur in
person or via conference call or online conference.
The sponsor has live visibility over the results through
TEMPO as event adjudications are finalized and can
request further information or raise questions for
the committee on review of adjudication results. In
addition, event adjudication results could be queried
should scientific rationale exist or when new or
additional information is available from the sites/
sponsor regarding the event.
Following its development, the CEC module was first
used with a rescue trial conducted by a small biotech
company. In less than two months, approximately 350
events from the two-year study period were addressed
through the Clinipace-technology-enabled CEC
process. Of these, 85 were queried upon review, which
was accomplished in a one-day in-person meeting.
Background Processes within
Clinipace Worldwide and TEMPO
The fully digital TEMPO platform provides all
of the data needed for CEC operations because it
already stores all of the clinical trial data, including
site-reported events. Within the specialized CEC
module, the system automatically stores the
adjudication results and provides a full audit
trail of the process.
Committ