Incorporation In Regulation

Many of the CIOMS I criteria for expedited reporting were incorporated into ICH E2A, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, which reached final agreement in October 1994 (ICH, 1994). This document expanded on the CIOMS I definitions and terminology. In particular, it introduced the concept of the "medical" seriousness category that recognised that events may not be immediately life threatening, or result in death or hospitalisation, but may jeopardise the patient or require intervention to prevent such outcomes. Although ICH E2A focused on pre-approval clinical trials, its definitions and other criteria have been applied by regulators to expedited reporting of both pre- and post-marketed products. The reporting time frame was reduced from 15 working days to 15 calendar days, with seven days for the initial report on fatal or life-threatening suspected adverse reaction cases from clinical trials.

the specifications for the standard units for laboratory data. Many of these definitions and recommendations were incorporated into the 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 November 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 COMS IA does not exist, pilot studies of electronic expedited reporting are in progress in Europe, Japan and the United States.

CIOMS 1A—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 initiative was run in parallel with the CIOMS III working 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 efficient 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 manufacturers. This would enable the entry of individual cases only once by either a manufacturer or regulatory authority, facilitate the entry and speed of availability 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

CIOMS II—PERIODIC SAFETY UPDATES

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