CIOMS IA was completed in 1995 but the final report was never formally published by CIOMS.
CIOMS IA - HARMONISATION OF DATA
ELEMENTS AND FIELDS FOR ELECTRONIC REPORTING OF INDIVIDUAL ADRS
CIOMS
IA was completed in 1995 but the final report was never formally published by
CIOMS. The initia-tive was run in parallel with the CIOMS III work-ing group
but is presented here, out of chronological order, because it was an extension
of the CIOMS I initiative.
The
vision of CIOMS IA was for the more effi-cient and rational exchange of safety
information by electronic rather than paper submission of expedited reports.
Ideally, submission would be to a single shared database accessed by all
regulatory authorities and with appropriately restricted access for
manu-facturers. This would enable the entry of individual cases only once by
either a manufacturer or regulatory authority, facilitate the entry and speed
of availabil-ity of follow-up information, ensure that everyone had access to
the same data at the same time and reduce the administrative processes
associated with hard-copy reports. Increasing the efficiency of the process and
standardisation of the data elements and fields would theoretically increase
the time available for signal detection and evaluation activities.
CIOMS
IA produced detailed definitions of the data structure required for both
administrative and case details for electronic reporting of individual expedited
ADRs. This even included the specifications for the standard units for
laboratory data. Many of these defi-nitions and recommendations were
incorporated into a similar project initiated under ICH around the same time as
CIOMS IA was active; the former reached final agreement in July 1997 as ICH E2B
(ICH, 1977). The document was subsequently revised in Novem-ber 2000 to clarify
some of the issues raised during pilot feasibility studies and became ICH E2B
(M) (ICH, 2000).
Although
the single database envisioned by CIOMS IA does not exist, electronic expedited
reporting now occurs in Europe, Japan and the United States.
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