On October 14, seQure, the business unit of Arithmos, hosted a second edition of the free webinar on importance of quality case processing in pharmacovigilance operations.
During this webinar we described the best practices in case processing and common sources of bias and presented case studies. The webinar was followed by a Q&A session.
The webinar was conducted by Stefania De Santis, Director of Pharmacovigilance of seQure.
Meddra SMQ: do you have an example of sing this modality?
SMQs are predefined sets of selected PTs used mainly in searching the database for specific pathological conditions. The only error could be to select a SMQ that is not feasible to the scope.
In case of exposure during pregnancy which SOC we should choose?
It is recommended to choose the Primary SOC “Injury, poisoning and procedural complications”.
In case of ambiguous information and clarification is not possible, would it be correct to assume certain clinical judgements and provide the rationale for the same?
Yes, but only in the narrative, as Company Comment.
How to improve consistency in MedDRA coding within a team?
Conduct trainings on the MedDRA Points to Consider. Also, the creation and maintenance of a “synonyms list” could be very helpful. Even if it is unpractical for teh application to all adverse events received, it could be useful for recurrent verbatims and Adverse Events of Special Interest (AESI).
On which critical data should we focus focused during periodic data checks?
This is a very good question, since periodic data checks are often made on many cases and it is not possible to check manually each database field. Business Intelligence tools may really help as they can extract tables showing the content of the most critical fields. This includes the E2B fields such as ADR Verbatim, ADR PT terms, seriousness, and outcome.
In case errors are detected during data check, how should we manage the corrections? Should we consider follow-up reports and resubmissions to Eudravigilance?
The first step before starting with data check is to prepare a Data Verification Protocol, in order to keep track of which fields will be checked and how correction will be managed. GVP Module VI reports example of corrections/amendments of data which need to be submitted as follow-up reports rather than as Amendment Reports.
Regarding revision of MedDRA coding by a physician, is it acceptable not to select a primary SOC but a secondary one, which is more suitable to reflect the clinical nature of the adverse event?
MSSO strongly discourages this practice. It undermines the intent of MedDRA as a standard terminology. It would be challenging for a reviewer at regulatory authority to compare the safety data of similar products from two different organisations if one freely assigned the PTs to SOCs of their choosing and the other used the standard primary SOC allocations. However, the clinical reasoning of the physician could be reported in the Company Comment of the narrative.
