A position paper recently released discusses data archiving clinical data.
Much of the focus on clinical trial data is on the collection, quality, and validity of that data at the time it is collected — as it should be. However, while not the first thing people consider when planning a clinical trial, archiving data must be done to a standard that will preserve data validity well into the future. A joint task force (the European CRO Federation and the eClinical Forum) has recently reviewed this topic and has now released a position paper. The paper highlights 11 key positions that address areas where regulatory expectations are not always aligned with industry practices.
At the end of a trial, the sponsor, the investigators, and institutions receive archive copies of the clinical trial data. Historically, this data would come from the computer systems used during the trial. It would consist of PDF files (flat files) containing copies of the data entry forms. However, archiving the data in this format alone is no longer considered sufficient.
The archival format should reflect the dynamic nature of the information being archived to permit evaluating a trial's conduct and the quality of the data produced. In other words, the archives should include the patient data, audit trails of data entry, the query history, users' access log, and other relevant metadata. Controls should also exist to preserve the integrity of the archive data consistent with ALCOA+ principles.
The full-length version of the position paper can be found here: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials-Version A, 2021-02-24.
Alan Yeomans, a long-time thought-leader at Viedoc Technologies and within the clinical trials industry, was chair of the joint task force responsible for writing the position paper.
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