Clinical Events Adjudication in the Digital Age | Page 7

Data handling and rigor
There is an expectation that clinical data are handled
with a level of rigor throughout the entire clinical
trial that instills confidence in subsequent product
approval decisions.

data from committee meetings, and the CEC members
sign off on the events and final results for final validation.
A full audit trail of all data handling is available
electronically for every event.

With a CEC, the adjudicated data are used in the
analyses. However, rigor is lacking from the traditional
CEC process, which has multiple touch points for
the adjudicated data. Verbal decisions in committee
meetings are transcribed to meeting minutes, which are
then manually entered into a database, or potentially
multiple databases, for analyses.

Summary of Benefits of Technology-Enabled
Clinical Events Committees
Technology-enabled CECs can reduce the time,
cost, errors and member burden associated with the
traditional CEC process by reducing the necessary travel
for geographically separated members, reducing the
amount of paper and printing, minimizing manual data
entry and facilitating central monitoring (Figure 5).

Traditional

With the Clinipace CEC service, the adjudicated
data are treated with the same level of rigor as all
clinical data. The adjudicators enter their decisions
directly into TEMPO, which stores those data and any
associated comments for analyses. The Clinipace team
member managing the CEC process enters all of the

Final reporting
TEMPO facilitates final reporting to regulatory agencies
because it stores all trial-related data and information
from study start-up to completion.

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Figure 5. Traditional clinical events
committee processes are heavily
paper-based and time-intensive
compared with the technologyenabled process, as with TEMPO

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