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eCF Webinar: Best Practice Recommendations for Changing eCOA Data
Historically, each sponsor, contract research organization (CRO), clinical site, and eCOA service provider has handled eCOA data change request (DCR) processes differently, resulting in the possibility for mixed expectations among the stakeholders and inconsistent results. In the worst-case scenario, there is the risk of findings from inspections and audits, either because control over source records did not reside as expected with the site, or because there was a lack of oversight over eCOA data changes requested by sites and performed by the eCOA service provider. There is a need for a well-defined, consistent, and balanced process for handling eCOA data change requests in clinical trials. The objective of this document is to outline best practices that will result in improved data accuracy and integrity, greater transparency amongst the different stakeholders, increased consistency throughout the clinical trials industry, and adherence to the study protocol, good clinical practices (GCP), and government regulations. The approach to eCOA data changes outlined here is focused on patient-reported outcome (PRO) data but can be applied, where appropriate, to all eCOA data, including clinician-reported data and observer-reported data.
A collaborative team comprised of Critical Path Institute’s ePRO Consortium, PRO Consortium and eClinical Forum have been meeting since early 2020 to discuss this topic and produce a best-practice recommendations paper. They will be sharing their discussions during this webinar. The associated paper is anticipated to be published during 1Q 2022.
eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.
We will be discussing a recent eCF/EUCROF positions paper:
The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities. Many of the computerised systems used during a trial are only used during the active trial data collection stage. This period of use is shorter than the retention period required for the archiving of the essential documents of the trial. Furthermore, the documentation that makes up this history is distributed between sponsor, investigators and vendors. Data is stored locally, in the cloud, on patient devices, at vendors, and sub-vendors. Where the data is archived (sponsor, investigator, vendor), in what format (kept live or static), and for how long are issues discussed in the position paper. You can download the position paper here: Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 (eclinicalforum.org)
Our grand vision is to set the standard for processes and to make a difference within the clinical trials industry. Being members of the eClinical Forum is a key component in this strategy.
Mats KlaarViedoc Technologies
Through the network of eCF, direct exchange with regulators is possible and allows us to discuss and provide inputs into new guidance.
John SmithBoehringer Ingelheim
The CTU/section for Data Management at Oslo university hospital was approved for certification according to the ECRIN standards in July 2019. One of the tools used for the requirements for data capture tools was the eCF “Requirements for Electronic Data for Regulated Clinical Trials".
Cecilie MoeOslo University Hospital
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"... a group of professionals that not only recognize and discuss challenges, but actually drive strategic direction"
"... the best, most productive and informative group I have worked with in a long time.."
