Trial report forms

Good trial report form design is vital. The layout must be simple and easy to follow. The requirements for good forms are shown in Box 7.9.

♦ Include a copy of all trial report forms and questionnaires in the protocol.

♦ Use self-copying forms when possible, the top copy to be sent to the trials office, the other to be retained in the patient's notes.

♦ In designing the forms, be careful to ensure that the layout and wording are simple, direct and easy to understand so that the forms are easy to complete without ambiguity. Missing items should be obvious at a glance.

♦ Include only such questions as are essential for answering the trial questions.

♦ Wherever possible, use a simple coding style or a box-ticking style; avoid text entries.

♦ Ensure that all questions are worded in such a way that they require an answer.

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