Instructions for subsequent monitoring visits

♦ Describe what source data verification is required and the procedures for undertaking it. These may include identifying a random selection of data for verification, and the procedures for ensuring that the relevant patient notes and facilities for checking data are made available in confidence.

♦ List the people who need to be seen. These are likely to include collaborating clinicians, a pharmacist, locally involved research staff, and the person responsible for coordinating quality of life assessments.

♦ List the documents that need to be taken. These include copies of the protocol, copies of reports of all previous visits to the centre, copies of all report forms with outstanding queries, and a list of any problems relating to the data from that centre.

♦ Include instructions for checking that the centre is complying with the protocol, including the prompt reporting of serious adverse events.

♦ Emphasize the desirability of sorting out and correcting any data discrepancies or other problems during the visit.

♦ Include a copy of all standard documents for the visit, including standard letters, a monitoring visit checklist, a source data verification form, and a visit report form.

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