Mapping the Way Forward: When Is It the Right Time to Consolidate Safety Data?
From time to time, we like to feature questions from our clients in our DSN blog. This series, called Mapping the Way Forward, is intended to share information that may benefit other clients. Here is the latest question we received from a DSN partner who works with clients in the clinical space.
Q: “Our client is working on finalizing a protocol with us and at the same time is working with a CRO in China for a different study there. They have gone done the road of planning that each CRO builds an Argus (Oracle) database as their PV system. I know DSN uses Argus as well. Eventually we need to put the global data together, so I wonder if these two systems can work together, for example, if the data can be exported and imported into another system easily?
A: Great question and yes, they will ultimately need to consolidate their safety data and databases going forward as the product matures in its lifecycle and with the hope of moving towards marketing approval, plus meeting cross-reporting responsibilities.
Argus can transfer information via many formats with E2B. There are several ways to do this.
The highest priority would be for cross-reporting obligations while studies are being conducted simultaneously. An option for low volume is for each CRO to transfer a SUSAR by Day 4/10 via E2B format with a CIOMS II line listing and associated CIOMS I/MedWatch form. Then each recipient CRO can ensure cross reporting per their studies requirements.
Alternatively, one CRO can receive and manage as well as enter all SAEs for all studies and utilize a local CRO for assistance with regulatory submission. For example, a U.S.-based CRO receives all SAEs for all studies, queries, and prepares the SAE cases in Argus. When a SUSAR occurs, the U.S. CRO will forward the required SUSAR files to the local Chinese PV contact who will then proceed with submission activities per local Chinese requirements. This avoids the reconciliation of merging of the safety data down the road. This also provides a searchable and comprehensive safety repository for DSUR and IB/Labeling preparation.
Alternatively, at the end of a study all SAE/SUSAR cases can be transferred to whomever is the "global repository", or the safety database considered to be the main consolidated data warehouse. The cases would be transferred via E2B with a CIOMS II line listing and associated CIOMS I/MedWatch form, and zipped source documents. It is important to note that there is some manual effort with this process and some historical data is lost. Still, this is a very accepted
approach as it will provide a searchable and comprehensive safety repository and enables DSUR and IB/Labeling preparation. Hope that helps!
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If you have a challenging pharmacovigilance question, please send us a note at email@example.com and we’ll feature it in an upcoming DSN Mapping the Way Forward blog. Thanks!