Clinical Events Adjudication in the Digital Age | Page 8

TRADITIONAL CEC

TECHNOLOGY-ENABLED CEC

Separate data handling from the
rest of the trial

Fully integrated, single digital source
for all study data

• Often requires considerable interactions
between various safety roles within
same study

• 24/7 access available to all study roles
• Full audit trail for all trial data

• Less rigorous treatment of adjudicated data

Need for meetings to adjudicate
any event

Meetings only necessary for discordant results
• Fewer meetings required

• Often requires travel

• Most events adjudicated online

• Difficult to accommodate schedules
for multiple meetings

• More effective meetings due to online
availability of data

Resource-intensive meeting preparation
and support
• All event-related information must
be compiled
• Large, paper-based data packets
for each member

Multiple instances of manual data entry
• Data are transcribed from meetings
• Reconciliation of data required

Limited data monitoring
• Adjudication results; available late in the study
• Difficult to address issues during short timelines

Lack of transparency in metrics
• Difficult to identify gaps in the process

Timeline extended due to time to close
the databases after site database lock

Central database: less meeting preparation
and support required
• Data are ready and available to support
meetings
• No compiling or copying and no postage
• No lost files of confidential information

Automated processes and minimal
data handling
• Direct data entry from the source
• No transcription required
• Therefore, no reconciliation

Reports are available from TEMPO 24/7
• Events can be reconciled at any time
during the study

Metrics can be obtained from TEMPO 24/7
• Full