Developing a Practical Method for Validation of Computerized Systems Integrated With Smart and/or Wearable Devices for Regulatory Compliance of Clinical Trials.

Abstract

The use of smart and/or wearable devices for collection of electronic data in clinical trials has recently become a strong tool with which to collect patients' data in a timely manner. Electronic collection of patient data will necessitate comprehensive data analysis involving huge-scale datasets in the future. However, it is still unclear how to validate and qualify computerized systems used to collect and/or manage electronic clinical data when smart and/or wearable devices are involved. We (a special interest group of Good Automated Manufacturing Practice Japan Forum [GAMP Japan]) investigated and designed a data-flow model for a clinical data management system involving smart and/or wearable devices, and suggested an approach for the validation of such a computerized system. The appropriateness of applying GAMP5 to the validation of a clinical data management system involving smart and/or wearable devices was also reviewed. A regulated company should have policies and standard procedures for validating computerized systems in clinical systems. When a sponsor engages a contract research organization (CRO) for clinical data management, the sponsor should assess the CRO to confirm their capabilities. The sponsor also needs to check whether the CRO assesses device manufacturers as sub-suppliers. When the CRO intends to conduct sub-supplier assessment with a device manufacturer, a risk-based approach can be taken. We believe our method of system validation will be applicable to and will facilitate various clinical trials that involve smart and/or wearable devices.