What inspired this Wish List Request?
JMP Clinical’s definition of causality (i.e., drug-relatedness) in the Treatment-Emergent Adverse Events (TEAEs) Summary report can be inconsistent with users’ causality data (i.e., AE.AEREL or ADAE.AREL).
Please describe the new or improved feature or solution you would like to see.
The TEAEs Summary report would be better to have an option that allows users to customize the definition of causality.
What would the value be to you and/or other users if this new feature is provided?
According to the guidelines, the terminology of drug-relatedness (i.e., AE.ARREL and ADAE.AREL) can be different from company to company (or trial to trial). If users are allowed to customize the definition of causality on the TEAEs Summary report, they can count drug-related AEs correctly even when they use their own terminology of drug-relatedness.
Is this an external customer request?
It is a question from a prospective customer (Nippon Kayaku).
Is there a competitive software package that has this feature or solution that we should be aware of?
N/A
Will this impact a renewal, expansion, or adoption at a customer, and does this put an account at risk if we do not address this?
N/A
References
AE.AEREL in SDTM IG v3.4
Records the investigator's opinion as to the causality of the event to the treatment. ICH does not establish any required or recommended terms for non-device relatedness. ICH E2A and E2B examples include (up-cased here for alignment to SDTM conventions) terms such as "NOT RELATED", "UNLIKELY RELATED", "POSSIBLY RELATED", "RELATED", but these example terms do not establish any conventions or expectations. Controlled terminology may be defined in the future. Check with regulatory authority for population of this variable.
ADAE.AREL in ADaM OCCDS v1.0
Apply imputation rules for missing causality of study drug as specified in the SAP or metadata. May change case of text, such as from all uppercase in AEREL to mixed case in AREL.
