New CDISC guidelines streamline AE and SAE reporting
By Kathryn E. Vinson, MS, CCRC, with input from LeeAnn Phipps, PV Manager, DZS Clinical Services

Nobody wants adverse events (AEs), much less serious adverse events (SAEs) to happen. The reasons that we in clinical research despise AEs are multitude, not the least of which is that we are in this business to better the lives of all people, and AEs mean that something isn’t right. It could be the study treatment, it could be completely unrelated, but we all hate to see someone in distress. But to add to that distress, the standards for reporting AEs and SAEs are ambiguous to say the least. From study sites to the data management (DM) and pharmacovigilance (PV) teams, redundancy in data entry makes adverse event reporting a nightmare.

Fortunately, a new initiative established by Transcelerate and now in coordination with the Clinical Data Interchange Standards Consortium (CDISC) are looking to streamline this process, making the reporting of AEs and SAEs smoother and more efficient. For more information on how DZS has worked to maintain compliance with the FDA and PMDA required CDISC standards, click here to see “All Hail the King” on our website.

Why is this important?
For the sponsors of clinical trials, SAE reporting can proceed through a variety of pathways. While all AEs are entered into the clinical database, serious adverse events must also be reported to pharmacovigilance. From there, the SAE takes many journeys. It must be reviewed by the study monitor, entered and reviewed in multiple databases, and then further reviewed by the medical monitor and/or PV Physician to agree or disagree with site assessments of causality. And, then, because it exists in multiple locations, the critical data points of the event must be reconciled between systems. To further complicate the process, the data entries collected for AEs and SAEs may significantly differ from study to study.

Redundancy and inconsistency in SAE reporting can cause multiple problems at many different levels. Examples of these issues include:
• Confusion and inefficiencies at health authorities that perform initial reviews of case reports and SUSAR reports
• Missed safety signals by sponsors, which can lead to increased risks to patients
• Inefficiency in time and cost to reconcile data by sponsors and CROs
• Confusion at the investigator sites due to different practices across trials

In other words, a reported headache can become a migraine for all involved.

The initiative proposed by Transcelerate attempts to establish an approach to solve this problem. By systematically and comprehensively reviewing the current landscape, they were able to develop and evaluate a list of “Common Core SAE Fields.” They then further coordinated with CDISC to develop an industry standard related to data collection and reporting.

With these new CDISC guidelines, AE entry will be greatly streamlined by removing the redundancy in the data entry process.

Additionally, SAE reporting will undergo its first standardization since the inception of CDISC in 2013. Included in this standard are 71 factors pertaining to SAEs, as well as recommendations for the completion of the narrative section of the SAE report. A detailed listing of the CDISC recommendations can be found here.

What is the potential impact?
With the identification and agreement of common collection fields, the potential for streamlined data entry and reconciliation becomes more likely. Possible changes to future study procedures include:
• A closer one-to-one match of SAE data points captured in PV and EDC systems which will lead to more streamlined reconciliation and reporting.
• Direct entry of all SAE data into the EDC system which is synched or integrated with the PV database, ensuring the same data in both systems and easing the burden on the sites.
• A single-system approach where the PV database functions are incorporated into EDC systems resulting in a “single source ” for safety data.

The DZS Difference
Changes like this require forward-thinking, multi-functional collaboration, systems awareness, and the willingness to tackle complex challenges. That’s where we excel.

Here at DZS we know that when sponsors choose to partner with a CRO they have a lot of options. Our team of project managers and data specialists have decades of combined experience in implementing not only e-clinical technologies, but also have been working with CDISC standards since their founding in 2013. Reach out to us today for more information on how our expertise in CDISC reporting standards can be “Your Direct Line to Improved Clinical Performance.”