Pharmacovigilance specialists may face difficulties identifying all relevant MedDRA terms required to find all reports of a given adverse event. We performed observations of and interviews with pharmacovigilance specialists to formalize the MedDRA terms choice cognitive task. Results highlight that specialists explore the MedDRA hierarchy until they find a level including all the important terms but not too many irrelevant terms. Results feed requirements to develop tools that help specialists to choose relevant MedDRA terms.

Learning Objective 1: After attending the presentation of the poster, the learner should be better able to:
- Understand the current difficulties inherent to coding and searching adverse event reports with MedDRA terms
- Understand the MedDRA terms choice cognitive tasks
- Make informed design decision to develop or improve existing tools supporting the MedDRA terms choice task


Romaric Marcilly (Presenter)
INSERM, CIC IT / Evalab 1403

Laura Douze, INSERM, CIC IT / Evalab 1403
Cedric Bousquet, INSERM U1142 LIMICS
Sylvia Pelayo, INSERM, CIC IT / Evalab 1403

Presentation Materials: