Checklist for missing and inconsistent data

Many queries will need to be resolved by the collaborator 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 primary data.
Once all outstanding queries are resolved the data can be incorporated in the dataset.
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.
Develop a system of computer generated reports to monitor missing or inconsistent data – act upon them.
If missing or inconsistent data are repeatedly ignored by the collaborator, change strategy – send a letter, phone, email or visit.
Identify recurring errors or omissions quickly and bring them to the attention of the collaborator before they become a habit.
In some trials it may be policy to go back to source documents (hospital notes) to validate key items of the data. This requires a member of the trial team to visit collaborating hospitals and compare the data collection forms with hospital notes. This is called Source Document Verification (SDV).