CIOMS IA - Harmonisation of Data Elements and Fields for Electronic Reporting of Individual ADRs

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.