Clinical Events Adjudication in the Digital Age | Page 5

TEMPO-Enabled Clinical Events
Committee Process
TEMPO supports the logistics of
the CEC service through the CECspecific module. The underlying
premise of the CEC remains the same
with TEMPO, but the majority of the
steps are electronically completed
by the CEC members as events are
identified, allowing efficient online
adjudication and conflict resolution
when disagreements occur. This process
completely replaces the current paperbased standard with a more efficient
electronic process.
For illustration purposes, we will
assume a three-person committee,
including the chair and two members
who perform the initial adjudication,
although the CEC module within
TEMPO allows study-specific
configuration of the number of
committee members.
When an event recorded in TEMPO
requires adjudication, the CEC
members are notified by email, and
they have access to all of the relevant
information in TEMPO for that event.
The members’ decisions, which are
completely independent and
blinded, are entered directly into
and automatically stored in
TEMPO (Figure 3).

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Event Alert
via Email

Figure 3. The clinical events committee members are notified of an event recorded
in TEMPO by email. The relevant information can be viewed on any device, and the
adjudication results are then entered directly into TEMPO.

To ensure there are enough possible members for each study, Clinipace Worldwide
provides CEC member training. Then, with larger-volume studies, more members
are initially assigned to ease the burden, or members can be available to cover
vacation periods.

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Record Result

If the adjudication of the initial two
members is concordant, the event
adjudication is considered complete.
However, if the decisions of the two
members are not in agreement, the
event is automatically sent to the
CEC chair by TEMPO (Figure 4).
If the adjudication result from the
chair is concordant with one of the
first two members, event adjudication
is considered complete.

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Figure 4. Technology-enabled clinical events committee adjudication through TEMPO

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