eCOA Back-Up Strategies

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.