Guidelines for preparing core clinical-safety information on drugs : report of CIOMS Working Groups III and V (2nd ed)

A revised and expanded edition of the guidelines covering the minimum drug safety information that should be communicated by manufacturers to physicians and other prescribers.

The original guidelines were produced in response to the need to harmonize drug safety information. This work also includes the report of CIOMS Working Group V, which extends the original guidelines to include recommended safety information on drugs undergoing investigation.

The report of Working Group V is published as an additional set of proposals for the assessment and presentation of safety information in investigators' brochures.

Proposals, which follow the same practical approach, used to produce core clinical safety information, are intended to provide researchers with all relevant clinical and non-clinical information and to assist pharmaceutical companies in meeting their reporting obligations.

In addition, guidance is provided on the global distribution to investigators of new safety information, such as 7-day and 15-day alerts to serious, unexpected adverse reaction.

The proposals should also facilitate the work of ethics review committees when assessing the benefits and risks to participants in clinical trials. The book concludes with the text of the European Summary of Product Characteristics and a summary of the US FDA Requirements, examples of illustrative drug scenarios used by the working group, and a model of Core Safety Information proposed for a fictitious drug.