ICH PSUR Template Does Not Support The Suppression Of Non-serious Listed Cases (Doc ID 2018019.1)

Last updated on JUNE 05, 2015

Applies to:

Oracle Argus Safety - Version 7.0.3 and later
Information in this document applies to any platform.

Goal

Provide options to exclude the following in in Single Case Submission Support section (Under Summary Tabulations tab) of the ICH PSUR Report:

 i) Provide options to exclude Reports that are Non-Serious and Listed
 ii) Provide an option to exclude Literature, post-marketing trial, and solicited cases

 References to Regulations:
 A. Regulation referencing Literature, post-marketing trial, and solicited cases:

  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.80
 
 (iii) Periodic reporting, except for information regarding 15-day Alert reports, does not apply to adverse drug experience information obtained from  post marketing studies (whether or not conducted under an investigational new
drug application), from reports in the scientific literature, and from foreign marketing experience.¿

 B. Regulation referencing mandatory electronic reporting:

 Final rule effective 10-JUN-2015:  http://www.gpo.gov/fdsys/pkg/FR-2014-06-10/pdf/2014-13480.pdf
 

Solution

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