Table 1 Elements of the quality assurance plan for the Global Network’s Maternal and Newborn Health Registry

Study preparation and regulatory compliance

Institutional Review Board and Ethical Review Committee approved protocol, consents and recruitment materials

Curriculum vitaes and documentation of qualifications of investigators

Case report forms

Staff training^a

Data collection

Standard operating procedures

Manual of operations

Monitoring plan

Supervisory visits^a

Data analysis

Monthly monitoring reports

Quarterly monitoring metrics

Data Monitoring Committee