title: Methods Employed in Monitoring and Evaluating Field and Laboratory Systems in the ANISA Study: Ensuring Quality.
abstract: BACKGROUND
  The Aetiology of Neonatal Infection in South Asia (ANISA) study maintains operations in Bangladesh, India and Pakistan. We developed and deployed a multilayered monitoring system to measure performance indicators of field sites and laboratory operations. This system allows for real-time provision of feedback to study site teams and project stakeholders. The goal of this monitoring and evaluation system is to promote optimal performance and consistency in protocol application at all sites over the course of the study, thereby safeguarding the validity of project findings. This article describes each of the interdependent monitoring layers that were conceptualized, developed and employed by the ANISA coordination team.
  
  
  METHODS
  Layers of monitoring include site-level, central and database-related activities along with periodic site visitation. We provide a number of real-world examples of how feedback from the ANISA monitoring system directly informs a number of crucial decisions and course corrections during the project.
  
  
  CONCLUSIONS
  The ANISA monitoring system represents a transparent, understandable and practical resource for development of project monitoring systems in complex multisite health research projects.
authors.affiliation: From the *Centre for Child and Adolescent Health, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh; †Child Health Research Foundation, Dhaka, Bangladesh; ‡Centers for Disease Control and Prevention, Atlanta, Georgia; §Department of International Health, International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland; ¶The Aga Khan University, Karachi, Pakistan; ‖Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center, Omaha, Nebraska; **Christian Medical College, Vellore, India; and ††Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.
authors.forename: Nicholas E
authors.initials: NE
authors.lastname: Connor
authors.forename: Mohammad Shahidul
authors.initials: MS
authors.lastname: Islam
authors.forename: Melissa L
authors.initials: ML
authors.lastname: Arvay
authors.forename: Abdullah H
authors.initials: AH
authors.lastname: Baqui
authors.forename: Anita K
authors.initials: AK
authors.lastname: Zaidi
authors.forename: Sajid B
authors.initials: SB
authors.lastname: Soofi
authors.forename: Pinaki
authors.initials: P
authors.lastname: Panigrahi
authors.forename: Anuradha
authors.initials: A
authors.lastname: Bose
authors.forename: Maksuda
authors.initials: M
authors.lastname: Islam
authors.forename: Shams
authors.initials: S
authors.lastname: El Arifeen
authors.forename: Samir K
authors.initials: SK
authors.lastname: Saha
authors.forename: Shamim A
authors.initials: SA
authors.lastname: Qazi
mesh_terms: D001459:Bangladesh / Q000453:epidemiology; D019411:Clinical Laboratory Techniques / Q000592:standards*; D003625:Data Collection; D003955:Diagnostic Tests, Routine / Q000592:standards*; D062665:Epidemiological Monitoring; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D007223:Infant; D007231:Infant, Newborn; D000071074:Neonatal Sepsis / Q000453:epidemiology / Q000209:etiology*; D010154:Pakistan / Q000453:epidemiology; D010865:Pilot Projects; D012307:Risk Factors; D013048:Specimen Handling / Q000592:standards*