What Cases are Included in PBRER Section 6.2 and PBRER Section 6.3 of the ICH PSUR Report?
(Doc ID 2149457.1)
Last updated on OCTOBER 02, 2018
Applies to:Oracle Argus Safety - Version 7.0.3 and later
Information in this document applies to any platform.
The ICH PSUR report contains two Periodic Benefit Risk Evaluation Report (PBRER) sections:
- PBRER Section 6.2 - Cumulative Summary Tabulations of SAEs from clinical trials
- PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-Marketing Data Sources
1. Does the absence of a study drug cause events not to be counted in section 6.2?
2. What types of cases that are programmatically excluded from sections 6.2?
3. What types of cases that are programmatically excluded from sections 6.3?
4. Do sections 6.2 and 6.3 look at case assessments or event assessments?
5. In compiling the counts for sections 6.2 and 6.3, is the information in the Inclusion Criteria taken into account? Dates are used from the Inclusion Criteria tab if they are blank for 6.2/6.3, but what about the other Inclusion criteria such as age range, etc?
6. Are there any other exclusions in 6.2 or 6.3 that are data driven? For example, if a study drug is not selected the events will not be in the listing for section 6.2; is there anything like that in the programming for 6.3?
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