How eTMF reports differ from database queries

October 14, 2013

  • Wingspan eTMF

eTMF software enables tracking metrics across clinical trials, while presenting a series of challenges. Assuming that enough metadata is tracked in the system to satisfy reporting requirements, it must be summarized in a manner that is meaningful, consistent and thorough. It must also allow business users to move from a broad understanding business process compliance to more detailed insights, covering areas like completeness, document timeliness, and quality. This allows end-users to see problems coming, and target specific areas where various teams or partners struggle to perform as expected.


At the simplest level, some information can be obtained from counting records in search results, or from commissioning IT staff to run ad hoc queries directly against a production database. Either approach has significant challenges: time constraints and technical challenges limit the business user’s ability to make metrics consistent with the business process. On a software level,  ideal reports often require aggregating data across systems inside and outside the TMF, including fields from a CTMS system or Active Directory. Without building a full reporting solution, this leads to complex SQL queries or a mess of Excel spreadsheets.


Passing this on to IT staff isn’t a guaranteed win, as they must be sufficiently trained to understand business needs. An agile process where business users and IT pass back and forth a report for feedback has a high cycle time compared to a reporting system that allows exploratory reporting. Participants in these types of projects often discover the hard way that executing long-running database queries against a production system can add significant load to the production system. In the Wingspan eTMF Reports, these risks are mitigated by an ETL process that regularly pre-aggregates data ahead of time, arranging it as needed, so that reports can be driven by business needs, rather than technical expediency.


In order to provide accurate results, TMF metrics must be carefully designed to closely match the business process they track. In timeliness reports, this means defining which date ranges are used: a reporting solution should recognized that documents are processed differently if they are scanned, manually imported, or mass migrated from a de-commissioned system. Similarly, a TMF Completeness report must consider whether the document was anticipated or not (e.g. an Investigator CV vs. an Adverse Event). Quality Reports are particularly challenging, and must report on different types of failures, parsing through the sometimes storied path a document takes to become an “approved” member of the TMF (including the scenario where a document is mistakenly approved, then un-approved).


The Wingspan TMF reporting system provides a series of reports which track overall TMF performance (Completeness, Timeliness, and Quality), as well as task based reports (SMF Reconciliation and Coming/Past Due Documents). Each report shows several views of the data: the overall metric, one or more summary views, as well as a detailed view. These can be customized with numerous filters and aggregation options, which allow the user to drill into data or customize reporting options. The data underneath the report is refreshed regularly, pre-aggregating of data that normally exists across different systems. These reports support a robust Excel export, which allows a business user to export present-quality charts and data tables. Combine this with data designed for reporting, and you have an out of the box reporting solution available with your eTMF.