Quality Assurance and Quality Control

Training and Certification of Staff

In order to assure adherence to protocols, the Coordinating Center organizes training of field center staff.  CSCC has conducted central training sessions prior to the start of study enrollment.  The goal is to certify that field center staff can conduct protocols accurately and reliably.

Assessment of Data Quality from Multi-site field centers

Monitoring protocol adherence and data quality in order to identify problems on an on-going basis is performed for studies.  Such checks include:

  • Comparisons among field centers and among equipment at field centers to identify protocol violations, differences in interpretation, failure of standardization of methodology or equipment, and malfunction of measurement devices.
  • Descriptive statistics on selected variables by technician, to identify differences in the application or interpretation of the study protocol.
  • Tabulations and listings of incomplete or inconsistent responses on data collection forms; tabulations and listings of expected forms not received in a timely manner; and tabulations of field center error rates in data entry.
  • Analyses of digit preference for clinical measurements, investigation of correlations between variables and other evidence suggesting inadequate or fraudulent data collection.

Laboratory Quality Control

The CSCC has considerable expertise in laboratory quality control.  We designed and operated external quality control programs for standardizing 12 local lipid laboratories and a central clinical chemistry laboratory over a twelve-year period.  The current CDC lipid standardization program was developed as part of that project. We have designed and operated external quality control programs for central lipid, clinical chemistry, and hemostasis laboratories and central ultrasound, ECG, and pulmonary function reading centers for several studies.  The CSCC has developed detailed manuals of procedures for implementation of a blind replicate Quality Control program and trained staff in its use.

Reading Centers Quality Control

We have experience working with reading centers to develop quality control procedures using test pools and record libraries for repeat assessments to prevent drift over time and statistically evaluate the results for study sponsors.  We work with reading centers to establish a QC plan.

Data Quality Reports

Providing data collection personnel with timely, non-threatening feedback of problems and a course of action to resolve the problems is important. coordinating center activity.  We help document performance and reports provide a basis for setting goals within a field center and for tracking progress towards achieving those goals.