Trialspecific procedures

Trial-specific procedures for managing the trial and the data should be drawn up by the clinical trials manager, whether the trial is a large multi-centre trial being conducted by a

Type of form

Data collected

Registration/randomization

Patient identification details Eligibility checks Stratification factors

On-study/pre-treatment

Baseline patient characteristics

Treatment

Details of treatment given Treatment modifications Protocol deviations Adverse effects

Follow-up

Details of patient's status (dead/alive) Details of disease status (response) Events since last assessment

Relapse/recurrence Additional treatment Late treatment effects

Other forms may include: histopathological review, details of death.

Fig. 7.5 Basic set of trial report forms.

trials office or a trial conducted within a single institution or by a local group. Although most of the activities they describe relate to the conduct of a trial after its launch, they need to be planned and drafted in parallel with the trial protocol before the launch of the trial and we therefore consider them here. They should give clear instructions so that another clinical trials manager could take over the trial on a temporary or permanent basis.

For multi-centre trials involving more than one trials group, it is important to state which group is the lead group and to list the responsibilities of all the groups.

Trial-specific procedures must be kept up-to-date and revised as and when necessary. Although they can vary substantially from trial to trial, they should usually include the following information.

0 0

Post a comment