1: Protocol is designed to allow for surrogate to respond to selected questions when patient is too impaired to respond. CRF indicates when surrogate is responding.
1: Anticipated and unanticipated data quality issues are identified and appropriate solutions/mitigation strategies are devised in a timely manner.
2: There is a process in place for ongoing systematic quality checking and analysis of data during data acquisition to identify unexpected data quality issues in order to remedy them in a timely manner.
1: Definitions are agreed upon at design.
2: Codes are defined as appropriate to study settings: missing data from hospital record (e.g. not recorded) versus missing data from a study appointment (e.g. subject did not return etc.).
1: Mandatory elements require a value or explanation for reason missing.
2: Curation team is responsible for reviewing and accepting or rejecting explanations.
3: Data completeness for key variables is checked against pre-specified study design goals and minimum standards for data completeness in key areas are met.
4: Quality control is in place to ensure that completed clinical measurements or investigations such as imaging meet the specifications in the study protocol.