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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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