Trial management systems
There will be some overlap between the QA Plan and Trial Management Plan; However the Trial Management Plan should outline the arrangements for the day to day running of the trial to ensure efficiency. It may outline responsibilities of various individuals or groups, targets that should be met and issues that will need to be addressed regularly. It may involve setting up a Trial Management Group and also identify the Trial Steering Committee and Data Monitoring Committee and details of meeting schedules.
The extent of this document will depend on the trial risk and complexity however it can be applied to all trials. E.g. for a simple and low risk trial this document may just be an index of all the relevant SOPS. Alternatively, it may be possible to include all the necessary information in the protocol.
1. The Trial Protocol Tool has a useful section under RCT Management: http://www.globalhealthtrials.org/site_media/media/articles/trialprotocoltool/TrialProtocolTool.html
6. SOP: Template for Document Control: http://www.admin.ox.ac.uk/rso/clinical/downloads.shtml#SOPwriting
7. SOPS relevant for inclusion in Trial Management Plan – please note these are specifically designed for a UK University research setting: http://www3.imperial.ac.uk/clinicalresearchgovernanceoffice/standardoperatingprocedures
To return to the Global Health Research Process Map click the following link:
Please use the comment box to explain any problems that you have with this process step or any solutions that you have found to make this step easier for others. If you have any suggestions for additional resources or guidance, please provide these below.
The information posted in this group may be used for research purposes. If you would prefer your comments not to be used for research purposes please state this when commenting.