Monitoring


CRAs fluently speak and write the local
language(s) to be able to perform
proper Source Data Verification (SDV)


CRAs fluently speak and
write English to understand protocol
instructions and to communicate
to investigators


Monitor the progress of each
investigator/site and assure that ...

...the Study is performed in strict
accordance with applicable laws
and regulations including ICH-GCP
and EU directive and in strict
accordance with the Protocol and
all amendments

...investigator maintains complete
and adequate records of clinical
observations, laboratory tests and
other prime date

...information entered into the (e)
CRF is complete and accurate and
supported by source data

...all AEs, SAEs and specified events
are identified and reported timely

...the Study drug is stored under
appropriate conditions and maintains
complete and adequate records of
drug disposition