The processes for monitoring for the trials conducted by the TCC will vary depending on the needs of the trial, but at the minimum will include the following:

Statistical checks to examine data with too little variance, data with no outliers and data with an abnormally flat distribution (these checks are suggested by the International Society for Clinical Biostatistics subcommittee on Fraud, Statist Med 1999;18:3435-51). Checks are made within each collaborating centre and across the trial as a whole.

An independent Data Monitoring Committee will scrutinise the unblinded results of the trial while it is in progress to endorse continuation of data collection or cessation of the trial in the event of a clear result.

Investigators are responsible for retaining all original signed consent forms in the study file and, in accordance with local regulations, a copy may be required in the patient's medical records. Confirmation of consent will be verified during site data verification.

Data will be monitored to ensure collaborating centres are maintaining accurate data and sites will be subject to source data verification and independent audit.

Monitoring visits are carried out in order to:

A Monitoring Visit Report is completed at the end of the visit. In the event of serious unresolved irregularities in the data the coordinating centre may withdraw the site from the trial, the data will be deemed invalid and, if necessary, the relevant ethics committee and regulatory agency will be informed.

To understand the procedure to be followed by the TCC please see the TCC Standard Operating Procedure for Monitoring.