White Paper

eCOA Back-Up Strategies

Source: Kayentis
Meeting Evidentiary Needs With Electronic Health Records

There have always been, and there will probably continue to be, situations where an eCOA backup strategy is necessary. The reasons that justify implementing a back-up strategy include, among others, device failure or loss, the risk for the device to be forgotten by a patient when travelling, or lack of connectivity.

At the moment, the over-riding reason for a robust back-up strategy is the ongoing pandemic we are living through currently. This has generated the need for eCOA back-up strategies to be implemented very quickly. This has been required to cover situations where either patients were unable to go to sites or sites were unable to maintain on-site visits.

Kayentis invited a small, diverse group of experts to discuss the complexity of eCOA back-up strategies and address the clinical teams’ expectations during an online workshop. The workshop discussions and best practice recommendations are reflected in this whitepaper.

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