Quality Control of Data, Data Review and Discrepancy Management

Standard operating procedures (SOPs) and Work Instructions (WIs) pertaining to data review and discrepancy management are created and used by pharma to ensure that data recorded at the clinical study site is adequately tracked, entered and reviewed within the clinical study database. This data should be systemically and periodically checked for accuracy, consistency and completeness as well as ensuring that errors are investigated and resolved. Another term used to describe data review and discrepancy management procedures are SOPs and WIs outlining "quality control of data".

Quality control of data, data review and discrepancy management will also ensure that documentation exists at the clinical study site.

Quality control of data, data review and discrepancy management ensures that all data discrepancies between the Patient Case Report Form (CRF) and the clinical study database are investigated and resolved.

The SOPs and WIs created and used in pharma for quality control of data, data review and discrepancy management should also include an outline defining metrics for tracking progress, status and quality of the clinical study database.

SOPs and WIs, must include the following parameters:

• purpose
• responsibilities
• procedures
• documentation
• edit checks
• guidelines for handling errors
• error listings
  
• history of data revisions
• cover memos to cover receipt of error listings
• metrics
• tracking
• and much more.

It is advised that SOPs and WIs themselves be reviewed and agreed upon by the pharma team responsible for the clinical study before one patient data point is collected at a clinical study site and entered into the clinical study database.