Assess listedness for blinded clinical cases

Summary

Provide ability to perform RSI assessment for all product licenses involved in the blinded study, and provide visibility to all the datasheet/licenses involved as Investigational Medicinal Products (IMPs) (Enhancement 35543150)

Description

As per the GCP guidelines, for a blinded clinical trial case that includes comparators and placebos along with a test drug, all the drugs must be considered as Investigational Medicinal Products (IMP)s. Therefore, SUSARs associated with a comparator product must also follow the same reporting requirements as for the test drug. Hence, the initial expectedness assessment must be against both the test and the comparator RSIs.

If the reaction is unexpected for either, then the blind should be broken. And if the reaction is unexpected for the product the unblinding reveals, then SUSAR is to be reported appropriately. If the patient is revealed to have taken a placebo, then this is not reported as SUSAR.

Console changes

A new common profile switch Criteria for Event Level Assessment for Blinded Study is added under System Configuration > System management > Case Processing > Assessments with the following options:

• Include datasheet/licenses for the default blinded study product (default)

  This option retains the existing functionality to assess the listedness against default study product.

• Include datasheet/licenses for all the blinded study products

  This option facilitates listendness calculation to consider all product licenses involved in the blinded study.

Case form changes

The case form changes are applicable only when the System Configuration > System management > Case Processing > Assessments > Criteria for Event Level Assessment for Blinded Study common profile switch is set to Include datasheet/licenses for all the blinded study products.

The case form Event Assessment tab is enhanced to display all the datasheets and licenses for all the blinded products configured in the study configuration against the default blinded case product. The system auto-calculates listedness based on the RSI datasheet configured for the respective study product.

Note:

Using the same datasheet name across multiple study products might make it hard to distinguish between each study product. To identify products based on the datasheets, Oracle recommendeds to revise the datasheet names to include product name or identifier.

After unblinding the case, any listedness assessment done for the administered study product is retained in the case. All the event assessment records added for other non-administered study product against the blinded product are deleted from the case.

For the blinded users with configuration as Console > User Information > Protect From Unblinded Information, datasheet and listedness fields are restricted.

Local Affiliate - Local Labeling

Local Affiliate users can perform local labeling assessment for all IMPs and Comparator products involved in blinded study cases based on the current user privileges.

Report Scheduling

Report scheduling algorithm is enhanced to consider listedness of datasheet and licenses for all blinded company products to determine SUSAR/Unlisted to schedule reports. The system retains the functionality to schedule a report against primary license product, even if a report is scheduled as a result of meeting reporting criteria for any of the blinded product.

Periodic Report impact (CTPR, ICH PSUR, and DSUR)

• Inclusion Criteria tab > Datasheet for Listedness field

  In the Datasheet for Listedness field, when <ALL> is selected, then the most conservative listedness is considered to include all product licenses for all blinded products involved in the study for blinded clinical trial cases.

• Impact on Periodic report inclusion criteria
  • Common profile switch: Evaluate seriousness, listedness, relatedness, fatal across all diagnoses/events against product (seriousness, listedness, relatedness, fatal attributes from all of the diagnoses-product combination in the case is evaluated for case inclusion. If no diagnosis is present, then all events in the case will be evaluated).

    If this switch is selected, then listedness is calculated for all the blinded products configured in the study. Whereas, listedness is considered based on the selected licenses to be eligible for inclusion in the periodic report. If no license is selected, then the system considers listedness for all blinded products present in the case Event Assessment tab in addition to the other non-study products.

  • Common profile switch: Evaluate case inclusion based on following seriousness, listedness, causality option groups > Case Inclusion criteria for the ICH PSUR/CTPR report based on Listedness.
    • If the Use listedness of the primary event switch is selected, then listedness includes all the blinded products configured in the study against the primary event. Whereas, listedness is considered based on the selected licenses to be eligible for inclusion in the periodic report. If no license is selected, then the system considers listedness for all blinded products present in the case Event Assessment tab in addition to the other non-study products against the primary event.
    • If the Use case level listedness switch is selected, then the existing functionality is retained to consider the case level listedness for the case to be eligible for inclusion in the periodic report.

End Of Study Unblinding

The End of Study Unblinding (EOSU) utility recalculates event assessment against the administered study product. Any listedness assessment done for the administered study product is retained in the case. All the event assessment records added for other non-administered study product against the blinded product are deleted from the case.