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Table 3 Monitoring of serious adverse events during the trial

From: What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care

ACTION trial

Namaste trial

Regular telephone and face to face contact with clinical sites.

Data Safety Monitoring Committee review of:

 • Serious adverse event forms

 • Items from the Quality of Life questionnaires related to distress

 • Routine hospital admission and expected death information

 • Total number of patients screened for eligibility, who were eligible, asked for consent, and included plus response rates per study arm and per tumour type

Liaison with clinical staff, as necessary, to ensure an appropriate plan of care was put into place.

Regular telephone and face to face contact with nursing home sites.

Review of serious adverse event forms by study coordinating centre and findings reported to the Trial Steering Committee.

Monitoring of pain scores reported during the trial.

Study coordinating staff to report concerns to nursing home manager if pain scores high.