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CKB is located in ten geographically diverse and widely distributed regions of China. Every four to five years, about 25,000 randomly selected surviving participants are resurveyed. CKB has developed a wide range of bespoke IT systems to support periodic resurveys in China, covering paperless data collection,  centre and sample management, quality control and remote study monitoring. These systems are carefully designed and fully integrated to enable the smooth operation of resurveys and the timely collection of high quality data.

IT architecture

The CKB IT architecture consists of a large number of computers in the Oxford international coordinating centre (ICC), the Beijing national coordinating centre (NCC), and ten regional centres (RC) joined through secure internet connections and data exchange servers. Within the NCC and the RCs, there are multiple dedicated study computers (desktops, laptops, tablet PCs, and servers), each serving a well-defined purpose such as office use, data transfer, laboratory use, outcome verification, and field data collection. All study computers are whole disc encrypted in case of loss or theft.

In each regional centre the survey team sets up temporary assessment clinics at selected rural villages or urban street committees. At these clinics, each participant is instructed to go through a series of stations, where dedicated staff capture the relevant data using study laptops (e.g. laptop-based questionnaire). Each survey team has about 20 laptops including one or two in reserve.

For cost saving purposes, resurveys are conducted in two or three regional centres at a time. In a study clinic, all the laptops are interconnected wirelessly through a state-of-the-art Wi-Fi Mesh network to enable real-time and automated data synchronisation and backup. This network system includes: a flexible topology to fit any clinic site size and layout; an intelligent system engineered to self-learn and optimise paths for network connectivity; interchangeable physical devices and self-healing for minimal disruption when some nodes fail; multiple band technology for seamless and fast wireless signal performance and encrypted network traffic for security assurance.

Bespoke software

The resurvey IT systems cover four main categories: data capture; centre, staff, sample and asset management; data transfer; and study monitoring. They are developed following the standard iterative waterfall process in the software industry to ensure security, reliability, integrity, efficiency, compatibility, ease of use and future-proof. To facilitate remote support, all the IT hardware and software systems are carefully monitored, with regular trouble shooting and upgrade if necessary.

Data Capture

This table shows key stations and related IT systems developed for the 3rd resurvey. 

Table showing the results collected by software at different stations including saliva, urine and blood glucose test results, height, weight, blood pressure, bone density and lung function.

At the first station, each participant is allocated a unique study ID and has their photograph taken. The camera is attached to the computer, which is synchronised automatically to all other computers in the assessment clinic for identity checking purposes. At the last station a summary report is shown upon scanning the study ID and those who have missed particular stations are asked to return to complete them. Apart from a few dumb devices (e.g. height and hand grip strength measurements), all the data are captured electronically directly from the device, which is connected to study laptops via cables, USB, Bluetooth or Wi-Fi. Although each laptop is set up to serve a particular station, it contains the full set of software so that it can be activated easily to serve different tasks as part of contingency planning. In case of problems, software patches can also be rapidly applied by the CKB IT team in Oxford using the Software Update system.

Centre and sample management

Several bespoke IT systems are available, mainly on the regional centre office and laboratory PCs, to manage the study centre, staff, lab tests, samples, and study assets. Different programs are used for managing biological samples and wearable devices.   

Table showing the types of data collected on bespoke IT systems on the regional centre office and laboratory PCs, e.g from wearable devices and biological samples.

Data Transfer

During the resurvey, data is transferred and exchanged at various locations, including:  between the clinic laptops through a WIFI network at the assessment centre; between the study clinics and the regional centre office using a USB device; and between the regional centre office and the national coordinating centre through the internet. The Software Update system creates packages that are sent from international and national coordinating centres to regional centres, where the system installs the updates.

The CKB system allows for offline transfer, as internet connection may not be available or reliable at the assessment centre. The transfer of files between nodes is separated from the preparation and receipt of the various data types. The File Transfer system moves files of any type (including error report log files, and medical device data files) using any of the methods described above. Database data is exported to a file in XML format before being transferred, and is then imported by the recipient.

All files are encrypted end-to-end and signed using public key cryptography while in transit. Whenever a file is received an acceptance is sent automatically to the sender. To guarantee that data is never lost the sender keeps sending a file at given intervals until it receives an acceptance.

Monitoring

Bespoke programs are developed to allow central monitoring of study progress in the field and to provide a review of data collected over time at various levels.  There are also programs to monitor the clinic Mesh WiFi network:

'WiFiMonitor' ensures the optimum physical placement of the Wi-Fi nodes at the assessment centre and continuously monitors the quality and performance of the network in the data transfer between different study laptops.

'ClinicMan' monitors the status of each laptop, including ongoing activity, current operator, current participant, and stage of activity for the participant concerned.

Screenshot from 'ClinicMan' which monitors the status of each laptop, including ongoing activity, current operator, current participant, and stage of activity for each participant.

'ActivityMonitor' monitors the general status of a participant’s data flow as they progress through each station at the assessment centre.

Screenshot from 'ActivityMonitor' which monitors the status of a participant’s data flow as they progress through each station at the assessment centre.

Implication of biobank IT systems

Given the highly specialised nature of biobank studies, nearly all IT systems in CKB are bespoke, developed by a dedicated team in Oxford using different platforms and programming languages. In total over 100 bespoke IT systems are used at various locations and for different purposes, to support complex project needs while complying with security and data protection regulations. The successful development and application of these systems has transformed the way the study is run and managed. Our IT systems have greatly improved the quality and completeness of data collected, management efficiency, and cost-effectiveness of the study.