Expedite Clinical Trial Intervention Decisions: Investigative Site Optimization Series Part 4

Christine Tobin |

At best, paper-based patient reported outcome (PRO) data collection can provide clinical sites with preliminary study analysis within 60 days of study close. Determining if the study has even achieved appropriate statistical power can only take place after all data have been processed.

This greatly limits the site’s ability to intervene (if necessary) to ensure all data are coming in as expected. Even worse, the delay may put patient safety at risk because safety signals can only be observed at the site visit or when reported by the patient.

Electronic PRO (ePRO) data collection expedites intervention decisions relating to patient compliance and safety. Investigative sites gain greater autonomy and accountability for their study contribution with role-based permissions to access data collected.

Standardized and/or customized reports and alerts can notify sites of patient non-compliance or missing data, empowering them to initiate appropriate remediation. Providing sites with 24/7, online visibility into patient recruitment, consent, adverse event and compliance data ensures sites become true partners in study conduct and outcomes.  As a result, all trial stakeholders have the tools and insight needed to ensure the study’s success.

With ePRO data collection and e-reporting, all trial stakeholders can understand trial progress or spot potential problem areas for rapid remediation.

4 easy steps to centralized ePRO Data StorageThis is the final installment in the Clinical Site Optimization series, which shares practical, easy-to-implement strategies that help investigative sites succeed – and can have dramatic and immediate impacts on clinical trials.

Don’t miss these earlier posts, which focus on opportunities and technological implementations that replace previous time-intensive, manual methods and deliver significant cost, time and data quality benefits with minimal investment and disruption to current operations:


And, be sure to take a moment to examine additional content on effective site optimization, including a downloadable eBook.

Christine Tobin is the Corporate Communications Specialist at ERT.