Checklist for missing and inconsistent data

Develop a system of computer generated reports to monitor missing or inconsistent data – act upon them.
Many queries will need to be resolved by the investigator and these queries should be sent out as soon as possible with a clear request.
All query resolutions should go through the same checking process as the original data.
To comply with Good Clinical Practice (GCP) guidelines, all changes to the data should be clearly altered using a coloured pen, signed and dated. The source of the change should be filed with the original data form.
Once all outstanding queries are resolved the data can be incorporated in the dataset.
If missing or inconsistent data are repeatedly ignored by the investigator, change strategy – send a letter, phone, email or visit.
Identify recurring errors or omissions quickly and bring them to the attention of the investigator.