The FDA and other regulatory bodies have issued multiple guidance documents addressing requirements when using technology tools to execute paperless clinical trials. The push from the regulatory agencies has occurred despite a risk-averse pharmaceutical industry, still comfortable living in a “paper world.” This risk aversion is in part due to an irrational fear by sites and sponsors of receiving a FDA Form 483 when an FDA inspector discovers, for example, that a patient was born in 1982, when in the study database it is recorded as 1983, even when there is no impact on the study results. Additionally, the clinical sites are also fearful of losing business as a result of any FDA Form 483 finding, however minor.
The following are examples of regulated clinical trial software: 1) Data capture (EDC) systems; 2) Electronic informed consent; 3) Electronic trial master file (eTMF): 4) ePRO and eCOA; 5) Dedicated tablets collecting and storing data in real time; 6) Mobile Apps; and 7) Web-based systems collecting data in real time which transmit the data to the study database only after the source record is securely received and stored in an independent eSource storage location under control of the study site.
Upon completion of this Webinar, attendees should be able to:
Understand the future landscape of paperless clinical trials
Understand regulatory concerns when running paperless clinical trials
How to “separate toys from tools” when choosing mobile and related devices