Illustrative
example - Perinatal care trial
|
|
---|---|
Study
Organization
(CLAP Trial - go to protocol) |
Illustrative
example - Magpie trial
|
|
---|---|
Magpie Trial Steering Committee The overall progress of the trial will be monitored by a scientific and administrative steering committee. The membership of this committee is: Rory Collins, Lelia Duley, Edmund Hey, Richard Lilford, Jack Moodley, James Neilson, Stephen Robson, Peter Rubin (Chair), James Thornton, Sara Twaddle, and Isabel Walker. Observers are Marc de Bruycker, Barbara Farrell, Marian Kelly and José Villar. The UK Medical Research Council convenes this committee.
(MAGPIE Trial - go to protocol) |
Illustrative
example - INIS trial
|
|
---|---|
Trial Steering Committee The Trial Steering Committee (TSC) provides overall supervision of the trial on behalf of the Medical Research Council. Its terms of reference are:
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.
The Investigators’ Group will consist of the trial investigators, representatives of specific groups whose expertise is necessary for the trial, and investigators of any ancillary studies. This group will supervise the practical aspects of the trial’s conduct. It will resolve problems brought to it by the Project Management Group (see below) and will be responsible for organising reporting and dissemination of the trial’s results.
The Project Management Group (PMG) will oversee the day-to-day running of the trial. The responsibilities of the Project Management Group include:
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.
|
This is an easy to use tool that provides a graphical illustration of a schedule that helps to plan, coordinate, and track specific tasks in a project.
This checklist has been contributed by Barbara Farrell who prepared it for the second version of the Trial Management Guide.
This text has been contributed by Dave Sackett, who prepared
it
for
the forthcoming 3rd edition of Clinical Epidemiology; A Basic Science
for
Answering Questions about Health Care, to be published by Lippincott,
Williams
& Wilkins in 2005.
Barbara Farrell. Efficient management of randomised controlled trials: nature or nurture. BMJ 1998;317:1236–9
The Resource Centre for Randomised Trials (RCRT) aims to
provide a
central and generic archive of resources relevant to the process of
developing and doing trials. This will help maximise the
overall
investment made in trials. To ensure ease of access, whenever
feasible the materials within this library will be accessible via a
website that is regularly updated.
TrialsCentral provides free and confidential access to
listings of
clinical trials. Information about current clinical research helps
support informed evidence-based decision making in
healthcare.
The RESOURCES page links to health care information sites, including
medical dictionaries, articles, and links to other evidence-based
health care sites.
The Society for Clinical Trials, created in 1978, is an
international professional organization dedicated to the development
and dissemination of knowledge about the design and conduct of clinical
trials and related health care research methodologies.
The MRC Trial Managers Network is a forum for all MRC funded
trials.
Its primary functions are to link trial managers together to ensure the
dissemination of expertise and experience and to provide training tools
developed by the members of the network.