Standard Operating Procedures

To standardise procedures for the study management, field survey (including interview, collection of physical measurements, sample collection and processing), and collection and validation of long-term follow-up data, a range of Standard Operating Procedures (SOPs) has been developed.

General study management

·        Procedures for setting up a regional coordinating centre and sample storage facilities

·        Procedures for setting up IT systems and network at national and regional coordinating centres

·        Procedures for setting up and managing staff computers at regional coordinating centres

·        Procedures for data backup, transfer, exchange and synchronization

·        Management of study documents and computer files at study coordinating centres

·        Management of sample storage facilities at national and regional coordinating centres

·        Ordering, transport, receipt and inventory management of study materials and equipment

·        Guidelines for maintaining IT and information security

Organisation and conduct of field work

·        Procedures for setting up temporary assessment clinics in regional coordinating centres

·        Procedures for recruiting and training field workers

·        Procedures for conducting a survey of non-responders

·        Procedures for setting up, testing and activating survey laptops and devices

·        Procedures for registering and confirming participant’s identity 

·        Procedures for conducing face to face interviews using computerized questionnaires

·        Procedures for collecting, transporting, and electronic storage of informed consent forms

·        Procedures for local and central monitoring of study progress and survey data quality

Physical examinations

·        Measurement of body composition using Tanita body composition analyser (BC-418MA)

·        Measurement of bone density using GE Achilles ultrasound device

·        Measurement of 12-lead ECG using Motara ELI250 device

·        Measurement of hand grip strength (JamarJ00105)

·        Measurement of blood pressure and heart rate (Omron7430)

·        Measurement of carotid artery intima-media thickness using Panasonic GM72P00A Diagnostic Ultrasound system

·        Measurement of standing and sitting heights using Stadiometer

·        Measurement of waist and hip circumferences (Seca tape)

·        Measurement of exhaled carbon monoxide (MicroCO)

·        Measurement of lung function using Vitalograph spirometer

·        Measurement of pulse wave velocity (pulse Trace PCA2)

·        Measurement of room temperature and relative humidity in assessment clinics

·        General maintenance and calibration of survey equipment/devices

Sample collection, spot testing, handling and processing

·        Procedures for collecting blood and urine samples

·        Procedures for spot blood testing and data reporting

·        Procedures for spot urine testing and data reporting

·        Shipment of biological samples from survey clinics to regional coordinating centres

·        Procedures for processing and aliquoting blood samples at regional coordinating centre labs

·        Standard procedures for extraction of DNA from frozen buffy coat samples (CKB/BGI)

·        Shipment, receipt and check-in of biological samples using door-to-door courier service

Collecting and validating health-related outcomes

·        Long-term follow-up of cause-specific mortality using China Disease Surveillance Point system

·        Long-term follow-up of morbidity for 4 major conditions using established local disease registries

·        Follow up of hospitalized events through electronic linkage to local health insurance systems

·        Procedures for conducting outcome validation using hospital medical records

·        Procedures for conducting a survey of un-insured participants

·        Procedures for conducting a verbal autopsy on ill-defined or unknown death events

·        Procedures for collecting, transferring, processing and integrating health insurance outcome data

·        Procedures for checking, coding, validating and standardization of disease outcome data