Developing a Quality Control/Quality Assurance Program

A good quality control/quality assurance (QC/QA) program is essential to the internal and external validity of your research project. This chapter focuses on the model, rationale, and procedures for a QC/QA program for site preparation, behavioral and biological assessments, and the intervention (The NIMH Multisite HIV/STD Prevention Trial 2007). Quality control procedures are the methods used to ensure that data are collected in a standardized way and that procedures are operationalized with clarity. Quality control activities include the development and implementation of systems such as a standard protocol. Quality assurance activities address adherence to the protocol and study procedures, behavioral and biological assessments, and intervention (treatment and control conditions), and assesses whether the quality control procedures were effective. These activities can include onsite and central monitoring of data collection, implementation of interventions, and a review of a random sample of questionnaires. The chapter is organized to track the life of the research project, from start-up, through field implementation, to ensuring adherence to the study procedures, and validity of the data.