February 29, 2024

Patient-reported data often serves as a clinical trial endpoint, informing decision-making, and influencing healthcare policy and practice.

From disease symptoms and treatment side effects, to functional outcomes, whether physical, social, emotional or cognitive, trial data is captured using validated questionnaires to ensure the response options are standardized across all participants.

Maintaining the integrity and accuracy of source records is critical. Regulatory requirements across the board state that any changes or corrections to data must be dated, initialed, and explained. Inevitably data entry mistakes do happen, but any changes to patient-reported data need to be carefully managed and only allowed if considered critical to the trial. This is due to valid concerns such as recall bias—for example, a patient changing a response the day after they recorded it because in hindsight they decided a symptom or side effect wasn’t as bad as they initially thought. 

Historically, sponsors were tasked with approving or denying data change requests (DCRs) before implementation. However, regulatory directives now stipulate that the investigator, not the sponsor, is responsible for maintaining accurate source records. There has also been a need to put a clear, consistent procedure in place for managing DCRs.

About the webinar

In February, Sverre Bengtsson, Viedoc’s co-founder, and Alan Yeomans, Viedoc’s Regulatory Affairs Manager, hosted a webinar together with SCDM looking at the process of performing and documenting changes to patient-reported data.

During this 60-minute webinar, the Viedoc experts talk through how to adjust existing workflows to align with regulatory expectations surrounding patient-reported data, while ensuring investigators play a central role in the decision-making process for data modifications. 

Alan and Sverre go through some of the regulatory aspects and the core principles around current recommendations, including a plan for how to define if a DCR is critical or procedural, the roles and responsibilities of all parties involved, and how to manage a situation where the site and the sponsor fail to agree whether a change should be implemented.

This is followed by a short live demo on how DCRs are actioned within the Viedoc system, and a comprehensive Q&A session covering questions including:

  • What if my system doesn't allow changes to patient-reported data?
  • If you have ePRO implemented, how do you handle data from patients who have issues with technology, or who are physically incapable of answering for themselves? 
  • We are managing a fully decentralized trial where we are both site and sponsor, how do these two roles interact in the context of eCOA data changes?
  • What if a site coordinator enters data under the wrong subject and realizes the mistake shortly after? Is there a process for moving the data to the correct place?
  • If the data is used for an automatic calculation present in a second form, will the second form be automatically updated? 

Best practice recommendation

The webinar presentation focuses on a recent paper: Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes, which was published on SCDM’s website in December 2023. 

The paper, authored by specialists from the Critical Path Institute’s PRO Consortium and eCOA Consortium, as well as writers from the eClinical Forum, including Viedoc's very own Alan Yeomans, meticulously examines and recommends guidelines. It addresses one of the controversial aspects of eCOA data integrity—which should review and authorize any data changes. 

The industry needed a scalable process for submitting, evaluating, discussing, and implementing data change requests in clinical trials. The lack of a best practice for making eCOA data changes has created challenges for participants, site personnel, clinical research associates, service providers, and sponsors. Each stakeholder works to fulfill their own obligations within the responsibility of the protocol, good clinical practice (GCP), and the regulations, but the edges of best practice have been blurred to date. 

This article offers a much-needed outline of trial-specific processes with agreed-upon roles and responsibilities, and describes a workflow that allows investigators to maintain data accuracy, and ensures any data changes made are supported by clear justification and context.

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The webinar is available to watch on-demand on SCDM’s learning platform.

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