Exact(11)
We invited all participants to show their willingness to be interviewed on the trial consent form.
All gave written consent on a form separate from the trial consent form.
A few studies have focused on parents' understanding of the clinical trial consent form [ 11- 13].
Payment was requested and provided for 36 practices (eight also requested a copy of the trial consent form).
The ITT population (n=1400) was defined as all patients who signed the trial consent form and were randomised.
Fifty-one practices requested, and were sent, a copy of the trial consent form; of these 36 responded by returning the completed questionnaire.
Similar(49)
No reasons were given for refusing to opt into the SMS sub-study, although many of the participants who declined also failed to provide a mobile telephone number in the contact details section of their trial consent forms.
After completing the experimental drive, participants were asked to fill in the simulator sickness checklist again as well as a post-trial consent form to ensure that any feelings of discomfort they may have experienced had subsided.
All patients signed a clinical trial informed consent form that was notified to the European Institute of Oncology Ethical Committee.
This pack will contain a stamped sealable envelope, trial information, consent form, and a brief written parent questionnaire.
Among patients willing to participate in the trial, a consent form will subsequently be sent by mail in order to obtain written informed consent for randomisation and study enrolment.
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