CIOMS VII - The Future
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The CIOMS VI working group proposed that there be a single Development Safety Update Report (DSUR) for submission to regulators on an annual basis, with a consistent format and content which had yet to be defined.
CIOMS VII - THE FUTURE
The
CIOMS VI working group proposed that there be a single Development Safety
Update Report (DSUR) for submission to regulators on an annual basis, with a
consistent format and content which had yet to be defined. They strongly
recommended that DSURs be based on an entire development programme and not per
protocol. Consideration should be given to establishing a common international
birth date which would be the date of first authorization to begin clinical
trials anywhere in the world. The DCSI should be attached to the annual DSUR
with an explana-tion of any changes since the last update, with any significant
new safety information highlighted. Hence the CIOMS VII working group was
formed to make recommendations on the format of the DSUR.
Progress
on this and future CIOMS topics can be monitored on the CIOMS website
(www.cioms.ch). The CIOMS VIII working group on data-mining had convened as
this chapter went to press.
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