- Data entry at source by local research staff or at the coordinating centre
- When the form instrument is empty the status is set to "incomplete" (red), i.e., instrument or assessment is incomplete and data cannot be obtained
- When data entry is complete incomplete and the instrument is still being collected the worked on, the status is set to "unverified" (yellow)
- When the form is ready for data monitoring (no more data will be available), the status is set to "complete" (green)
- Data monitor reviews eCRFs reviews complete/green instruments and raises queries, which are directed to the study or site coordinators (send an email or use REDCap messenger to notify study personnel that queries have been raised)
- The study or site coordinator responds to the queries
- Data monitor accepts and closes the queries
- Data monitor locks the eCRFinstrument
- Forms that are missing (no data expected) are left incomplete (red) and locked
- If required, the PI performs the final check and a final check of locked instruments and applies an e-signature to the form (this will be cleared if the instrument is subsequently unlocked)
Data entry staff and coordinators can add comments to data fields to assist the data monitor, e.g., to explain missing values, or the reassure the monitor that outliers are true values.
REDCap’s data quality module allows the study team to implement data quality rules (edit checks). Typically these rules would be developed and used by data management staff. However they could also be developed for use by study monitors . (Traditionally traditionally monitoring and data management roles have some similarity/overlap). Data quality is accessed from the right hand panel in REDCap.
These are raised by clicking on the speech bubble next to the data field. It is important to assign the query to an right person so that it appears in their data quality work flow. Once queries have been raised, send study personnel an email or use REDCap messenger (which can be programmed to send an automated email) to notify them that queries have been raised.