Obtaining recording and checking data

To obtain reliable data, it is helpful to provide collaborating centres with a schedule of dates for treatments, assessments and investigations for each patient on registration or randomization in the trial. A typical example of such a schedule is shown in Fig. 8.1. The importance of collecting, recording and checking data efficiently and accurately cannot be overemphasized. This is most likely to be achieved if the trial management group keep in close contact with all collaborating clinicians and local coordinating staff by telephone, correspondence and visits, and at formal and informal meetings. They must ensure that centres are kept supplied with report forms, that they fully understand them, that they complete them correctly and accurately, and that they answer queries. They should regularly ask for missing or overdue forms to be sent.

There are two components to checking data: checking that the data are recorded correctly onto the report forms by collaborating centres (source data verification), and checking that the data are correctly entered by trial data management staff onto the database.

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