Mitigating the Challenges of Clinical Trial Monitoring: A Technology- | Page 8

Remote monitoring of the study and
data,6 for example, can evaluate:

Focused on-site monitoring visits
can evaluate:

• Subject eligibility checks prior to randomization

• Ongoing training/site staff motivation

•  ates of recruitment, withdrawals and losses to
R
follow-up by site

•  nderstanding and adherence to study protocol,
U
procedures and study management and compliance
requirements (including any conditions in regulatory
or ethics approval)

•  hecks for missing or invalid data (range and
C
consistency checks)
•  hecks that dose adjustments, investigation and
C
management of events are consistent with the protocol

• Review of consent procedures

• Calendar checks to assess protocol compliance

•  ource data verification (as appropriate for the
S
particular trial, considering investigational product,
safety profile and phase of study)

• Checks for unusual data patterns

•  erification that resources and facilities remain adequate
V

• Assessment of adverse event and toxicity reporting rates
• CRFs completed by authorized persons

•  erification of appropriate oversight and documented
V
delegation by the Principle Investigator

•  xternal verification (with participant consent) of
E
events (e.g,. birth, disease and death registries)

•  erification of investigational product accountability
V
and storage conditions

Save Costs. In addition to reducing travel costs, the dCRO approach
saves costs by using fewer people more efficiently. Traditional CROs
charge for personnel by the hour and add technology at an additional
cost. They also compartmentalize clinical trial functions, which results
in redundancy and wastes time and money because of communications
challenges. The dCRO begins with technology and adds the minimum
number of people to do an effective job, realizing cost savings.
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