1: Database has flags for identification of when CRF completion or a study visit is overdue.
2: Automated weekly messages sent to coordinators listing overdue eCRFs.
3: Central study staff responsible for monitoring overdue CRFs.
1: Database has flags for identification of when CRF completion or a study visit is overdue.
2: Automated weekly messages sent to coordinators listing overdue eCRFs.
3: Central study staff responsible for monitoring overdue CRFs.
1: Scheduled queries are run for data checks across tables/CRFs for variables prone to conflict.
2: There should be rules to ensure that incompatible choices are excluded both within a data element (e.g. cannot be both male and female) and between related elements (e.g. male cannot be pregnant).
1: ‘Other’ checkbox included in field response options as appropriate with free field text for description.
2: Free-text fields set as containing PHI to avoid inadvertent export/release of personal information.
1: Avoid free text fields when possible.
2: eCRF has automated error flags to prompt immediate alert to review entries that don’t pass validation with option to override when appropriate.
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.