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Trial Steering
Committee
The Trial Steering Committee (TSC) provided overall
supervision of the trial on behalf of the Medical Research Council. Its
terms of reference were:
1. To monitor and supervise the progress of the trial towards its
interim and overall objectives.
2. To review at regular intervals relevant information
from
other sources (e.g. related trials).
3. To consider the recommendations of the Data
Monitoring and
Ethics Committee.
4. In the light of 1, 2 and 3 above, to inform the MRC
Council
and relevant MRC Research Boards on the progress of the trial.
5. To advise the MRC Council on publicity and the
presentation
of all aspects of the trial.
Meetings of the TSC took place at least once per year.
Investigators’
Group
The Investigators’ Group consisted of the
trial
investigators, representatives of specific groups whose expertise was
necessary for the trial, and investigators of any ancillary studies.
This group supervised the practical aspects of the
trial’s conduct.
It resolved problems brought to it by the Project Management Group
(see below) and was responsible for organizing reporting and
dissemination of the trial’s results.
Project Management
Group
The Project Management Group (PMG) oversaw the
day-to-day
running of the trial. The responsibilities of the Project Management
Group included:
i) recruitment of participating centers
ii) distribution and supply of data collection forms and
other
appropriate documentation for the trial
iii) data collection and management
iv) organization of the distribution system for the
treatment
packs
v) organization of the follow-up of children at 2 years
if
age, including the distribution of questionnaires, follow-up of
non-responders and liaison with local ‘follow-up’
personnel
vi) data entry and cleaning
vii) data analysis
viii) collection of adverse event data
ix) organizing and servicing the Data Monitoring and
Ethics
Committee.
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Dave Sackett, Trout Research
& Education Centre at Irish Lake, Canada, explains the main purpose and the
composition of a trial steering committee (MP4, 1 minute 8 seconds). Can't see
the audio controller? Play it in your
media player.