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

Last updated on JULY 13, 2023

Applies to:

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

My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.