Instructions for initial site visits by trial coordinating staff

♦ List the people who need to be seen. They could include participating clinicians, research nurses, a local data manager, the person responsible for coordinating quality of life assessment, a pharmacist, specialist nursing staff, and the person responsible for administering funding.

♦ List the documents that need to be taken. These should always include a standard checklist of what needs to be achieved during the visit. Other documents could include pharmacy instructions and record sheets, clinicians' agreement statements for signature, trial manuals containing all trial documentation, quality oflife packs, a supply of report forms, and protocol summaries.

♦ List the documents that need to be collected (or sent by post). These could include the local ethics committee's letter of approval, a copy of the patient information sheet if this has had locally relevant information added to it, signed agreement statements of collaborating clinicians, local laboratory normal ranges for relevant tests, a copy of the laboratory's certificate of accreditation, copies of any outstanding CVs, and details of the bank account into which support funding should be paid.

♦ State the procedures for reporting serious adverse events.

♦ Include a copy of all standard documents for the visit, including a visit report form.

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