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Table 4 Quality assurance strategies

From: CARRS Surveillance study: design and methods to assess burdens from multiple perspectives

Levels of quality control Phases
  Design and planning Pilot testing Data collection Data analysis
  Critical review of protocols Fluidity and feasibility of field operations assessed Monitoring field activities Audit and evaluate validity of findings prior to publication
Coordinating center     
  Common manual of operations for three study sites    
     Internal peer reviews prior to publication
  Coordination of timelines & activities    
Investigators Reviewed the design and planning of the study Results were audited after completion of the pilot Monitoring Validity checks
     Results reviewed
  Regular steering committee meetings    
Field Personnel Extensive training over a period of 7–10 days – theory and practical, field visits and shadowing by the study managers Evaluated all field and documenting techniques Random checks, re-training  
  Easy-to-carry operations guide provided    
Survey Questionnaires Peer-reviewed Established clarity and face validity in small field sample Regular checks done to assess completeness Compromised or inadequately completed questionnaires identify and discard
  Translated into local languages    
  Internal consistency estimates and reliability exercises through review of literature on survey instruments and their published data    
Measuring Equipment Centrally procured Evaluated calibration techniques, acceptability of use in field Regular calibration of equipment; faulty equipment replaced as and when required  
  Central training    
  Calibration guidelines and checks developed    
Specimens Kits and equipment procured centrally Evaluated adherence to protocols, labeling, processing, storage and handling
Interim analysis conducted to detect outliers
Random checks done Samples stored for future investigation
    External temperature gauge labels to monitor sample temperature  
     Compromised samples identify and discard
  Specific protocols for each biochemical assay was developed    
  Extensive training (labeling, handling, storage)    
Laboratory Laboratory selected and reference laboratory identified based on National Accreditation Board for Testing and Calibration Laboratories, Department of Science and Technology, Government of India (NABL) or College of American Pathologists, Northfield, IL, USA(CAP) certification Evaluated procedural fluidity Internal quality checks and calibration Assessment of intra- and inter-laboratory coefficients of variation
    Regular external validation – lyophilized samples from reference laboratory  
   Evaluated intra- and inter-laboratory variability   
   Analysis conducted to detect outliers   
  Internal and external quality assessment protocols and schedule of regularity developed    
Communication Reporting structures were established Agility of transfers assessed   
  Data transfer planned    
Documentation Checklists and logbooks were maintained Recording legibility assessed   Audit logbooks for response rates and field activity indicators maintained
  Training in appropriate and legible documentation    
Data Storage & Confidentiality Data back-up and protection policies have been established Accessibility, simplicity and flexibility of software assessed Locked and password-protected data storage Datasets de-identified
     Access to personal identifiers limited
    Active back-up  
  Training of all staff    
Data Entry Protocols, consistent data cleaning methods and verification systems were established Variability assessments conducted Interim analyses to identify duplicate entries Reporting on outliers
     Validity checks
    Decision log to document issues  
     Database errors tracked