Early Adopter Feedback Shows Value of Remote Source Document Review
Medidata Remote Source Document Review Feedback
Although regulatory and industry adoption of remote source document review has been available for years, regulatory headwinds made adoption more difficult. In an effort to support clinical trial continuity during the COVID-19 pandemic, regulatory agencies, including the US FDA, embraced the adoption of the technology.
In this post, we explore the results of our recently completed survey of site users of Medidata Remote Source Review, a cloud-based solution that rapidly and remotely enables monitors to acquire critical documents from sites, and automates document workflows to enable remote review of documents to support Source Data Verification (SDV) and Source Document Review (SDR). Early feedback demonstrates the value of remote source document review for both sites and sponsors.
Our survey was designed to gain a better understanding of site users’ experience and satisfaction with Medidata Remote Source Review so that we could learn how the sites were using the technology and ways we could further improve the experience. In March, Medidata conducted a survey of site-based users of Remote Source Review. The results that follow are based on feedback from 146 respondents, who were primarily clinical research coordinators at US-based research sites.
Survey Results & Key Learnings
Result #1: Majority of all respondents are supporting some or all remote document review
One of the most positive outcomes of the survey is that 75% of respondents are using remote source document review and averaging 10 document uploads per week.
Result #2: Respondents that are supporting remote source document review are seeing an average of 3.4 visits eliminated per month, saving them an average of 8.9 hours
Reflecting upon the recent ICH E6 (R3) draft guidelines that speak to improving the efficiency and quality of clinical trial conduct, remote source document review reduces the effort to support monitoring visits by an average of 8.9 hours per month. This data further supports an increase in efficiency as the average number of monitoring visits was reduced by an average of 3.4 visits per month. The reduction of monitoring visits is also advantageous to sponsors since it reduces the overall costs of a trial.
Result #3: Safety concerns are addressed quickly with remote monitoring
A primary driver of Risk Based Quality Management (RBQM) is to focus monitoring resources and efforts towards areas that impact participant safety and data quality. The data supports this shift, as 80% of respondents indicate that monitors identify and address safety concerns the same or more quickly than with on-site monitoring activities.
Result #4: Respondents spend more time preparing for remote visits than on-site visits (average 5.5 hours)
Remote source document review led to an increase in preparation time for remote visits compared to onsite monitoring visits. We speculate this increase is a result of the effort associated with uploading source documents. The data provides quality indicators and areas where Medidata can focus efforts to further support process efficiencies by creating technology solutions to enhance document upload.
Result #5: Most Medidata Remote Source Review site users are satisfied
The survey data indicated users are adopting the technology and are satisfied, although some additional efforts can be made to enhance their experience. As an indicator of potential growth and opportunities of remote source document review, 8 out of 10 respondents were satisfied and roughly half of respondents were highly likely to recommend Remote Source Review to colleagues.
As industry adoption of remote source document review continues to increase, early adopters are paving the way for the future. Overall, the valuable insights gained from the user perspectives and experiences help us better focus our product development in an effort to increase satisfaction and improve the user experience.
To learn more about Medidata Remote Source Review, visit our website.