In clinical research, internet-enabled technologies, such as electronic data capture (EDC) and fully integrated clinical trial management systems, can save time and costs. As a result, their use is becoming more widespread, and the FDA has encouraged use of technology to assess quality metrics in real time and help identify the extent of risk based monitoring that needs to be done at individual sites.1
Advanced and efficient trial management software consists of a single centralized system that integrates the spectrum of clinical trial functions so all stakeholders can access the same information in the same format at any time. An integrated system incorporates all functions and documents, including EDC, the electronic Trial Master File (eTMF), including regulatory documents and approvals, the clinical trial management system, the monitor visit reports, and the ability to audit for compliance.
With digital monitoring, data quality and protocol compliance can be viewed in real time. Off-site, monitors can immediately detect outlying data, site underperformance, or other areas that need support. Digital monitoring can decrease the amount of time monitors spend traveling to sites.
A less obvious benefit of digital monitoring is the potential for improved interactions between the sponsor, CRO, and study site team. Examples of benefits are—
- Real-time data sharing between CROs, sponsors, and site personnel facilitates decision-making.
- CROs that can share trial and process data in real time, both internally and with sponsors, can perform proactive trial monitoring and work collaboratively to control variability and troubleshoot.
- Constant remote monitoring of trial data and site performance can optimize the use of time during monitors’ site visits.
- In addition to streamlined source document verification, monitors can refocus time and resources on other unique issues of the site.
- Already captured metrics can be used as a basis for discussing performance and implementing any needed action plans.
- Monitor visits are less disruptive to patient care.
- In visiting study sites, clinical monitors can function more as coaches and less as inspectors in visiting study sites.
- The greater transparency between CROs, study sites, and sponsors can also lead to longer-lasting relationships that go beyond the current study
Interested in learning more? Be sure to register for our upcoming Clinical Trial Monitoring: A Technology-Amplified Approach webcast.
1. U.S. Food and Drug Administration. Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring. http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CDIQFjAA&url=http%3A%2F%2Fwww.fda.gov%2Fdownloads%2FDrugs%2F…%2FGuidances%2FUCM269919.pdf&ei=KQ4JUeehNYvC9gTflIBI&usg=AFQjCNGq1V2cuxoYl_w8KQPDeH573mYabQ&bvm=bv.41642243,d.eWU. Accessed Jan. 28, 2013.