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At Sticares InterACT,
Medical Review is performed by physicians with many years of clinical
experience and real knowledge of medical aspects of drug safety and
regulatory requirements. They
have excellent communication
skills
and pay
extra
attention to detail.
The Medical Review
team is responsible for:
ensuring the accuracy,
completeness
and medical
consistency
of data in clinical
trials
checking the consistency
of all patients’
data reported
in CRF or eCRF
detecting the incoherencies
between
all data of clinical
significance
creating data clarification forms
checking the medical
accuracy
and validity
of the English
translations
in CRF or eCRF
translated
fields
and the source
documents
performing the management of adverse events
within
timelines
through follow-up,
completing review
of the source
documents,
and preparing accurate and complete files for adjudication
writing patient
narratives
in defined
cases with
the aim
of assisting, if
necessary,
independent review
bodies such
as Regulatory
Authorities
or
Endpoint
Validation
Committees
collecting and transmitting
information
regarding
safety
and efficacy
concerns and
protocol deviations
performing the training of monitors regarding specific
procedures
data cleaning
and clarification
in the adverse
events
database
coding and code checking for adverse
events
and concomitant treatments
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