Critical Path Institute’s Electronic Clinical Outcome Assessment (eCOA) Consortium

eCOA Consortium develops new resource for best practices.

Proper training can prevent oversight of inaccuracy, error, and variability rates in data from COAs.

Intended use must not replace the clinical decision-making process.

eCOA and PRO consortiums along with regulators gather for discussion on important data collection topics.

Since electronic data collection started to gain traction in the 1990s, terminology has evolved and is in need of greater clarity.

Remembering Steve Raymond, PhD, "the Godfather of ePRO."

CDISC standards applicable to ePRO and other types of eCOA are still behind in the current regulatory landscape.

EU Medical Device Regulation must be followed carefully as it leaves room for interpretation.

Despite high potential of DHTs, regulatory picture remains unclear.

Final presentation at DIA reminds: "we are all patients."

Despite prevalent use in electronic devices, NRS and VAS are often implemented suboptimally.

Survey results emphasize need for flexibility in strategies.

Greater flexibility in eCOA solution could reduce need for backups.

Moving past the ‘if’ to the ‘how.’

Pandemic aside, remote solutions are advancing care in clinical trials.

Consortium looks to advance endpoint assessment through the development of eCOA best practices.