Paperless Processes on the Way Out?

In January 2014, the FDA presented a webinar “Promoting eSource Data Capture,” to explain its Final Guidance on Electronic Source Data in Clinical Investigations. In a slide, the FDA said the worst case for source data capture is “transcription of data from paper or electronic sources to the eCRF (electronic case report form).” The reason being that there was no intervening paper step needed, less confusion on what is source and the decreased likelihood of data errors.

In April of this year, we conducted a survey with SCORR Marketing to evaluate the paperless trial. In this survey, of 143 respondents, 25% said 0%-10% of their data collection in clinical trials was paperless. The next highest was 22%, who said that greater than 75% of their trials were paperless. And 15% said between 51% and 75% were paperless. So the majority fall in the middle of paperless processes, leaving room for greater adoption in the coming years.

In fact, the majority of respondents-27%-said that in the next three years, 75% to 99% of the processes for clinical trials would be paperless. With the plethora of new technologies surrounding data aggregation, mining, and analytics in all critical areas of study conduct, we can only see that our respondents are correct in their view.

For more information, download SCORR’s free report here.