Investigational Product Blinded

This data element is only applicable to ICSRs arising from clinical trials. The ICH E2A guideline states that individual adverse event safety reports from blinded clinical trials should not be unblinded. However, if the exchange of blinded ICSRs is important during the clinical trial, this data element may be used as follows: Until the blind is broken, this data element should be set to "true" to indicate that the treatment is "blinded". When this data element is "true", all items contained in the drug identification section G.k.2 should be completed with the investigational medicinal product information. When more than one investigational medicinal product is suspect, each suspect drug should be entered in a separate G.k block. After the blind is broken, where appropriate