Summary:
An in-process study contains subjects that might fail screening criteria at some point during the study. A team might want all data pertaining to those subjects to be expunged from visibility with one setting, rather than relying on Signals Clinical view and cohort configuration.
Details:
A study in Signals Clinical consists of a large set of Subjects that are identified by unique Subject ID values. As study data gets collected, it may come to light that a portion of Subjects fail to meet screening criteria. The study team wants to no longer see data belonging to such Subjects. This applies to all Visuals and Review Lists and Issue Management.
The study team does not want to depend on view and cohort configuration. A study-level 'failed screening' flag for each Subject would provide the best assurance, whose value would override any filter settings that may exist in the rest of SC such as cohort content or custom views or the default view.
Solution:
Currently SC does not contain a top-level setting to remove screen-failure subjects from all analysis.
An approach is to define your cohorts in Spotfire, and then share the cohorts to the Signals Clinical users. When subjects fail screening, filter them out in Spotfire and re-share the updated cohorts to the Signals Clinical user. The online Help content at the following location provides further detail: "Data Retrieval in Spotfire > Reviewing Line Listings in Spotfire® > Review Cohort Listings".
If Spotfire is not integrated with your Signals Clinical tenant, then the AI Listings Generator feature (an AI assistant) might be helpful when establishing updated cohorts (to filter out specific failed subjects). The online Help content at the following location provides further detail: " AI Listings Generator"
Comments
0 comments
Article is closed for comments.