Standard documents

Trial management is greatly assisted by having standard letters and documents for dealing with routine situations. Include copies of all standard letters and other standard documents in the trial-specific procedures indicating where they can be found. The following are examples of topics covered by standard letters.

♦ Approaching potentially interested centres not yet involved in the trial.

♦ Recruiting new centres.

♦ Confirming patient registrations or randomizations.

♦ Informing centres of overdue or missing data.

The following are examples of other standard documents.

♦ One-page protocol summaries.

♦ Clinicians' agreement statements.

♦ Quality of life assessment guidelines.

♦ Procedures for reporting serious adverse events and the associated report forms.

♦ Site visit checklists and report forms.

♦ Report forms for the supervising and sponsoring bodies.

♦ Pharmacy instructions and dispensing records.

♦ TNM and other staging definitions.

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