The Quality Assurance Plan should be developed at an early stage. The main goals of the QA plan are to make sure that the trial is able to answer the research question, to make sure data and results are reliable, the study is conducted ethically and in compliance with the protocol and regulatory requirements and the safety and rights of the patients are protected. The Quality Assurance Plan should outline monitoring plans, possible audits and also the setting up of Data Safety and Monitoring Boards and Trial Oversight Committees if required.
6. The Trial Protocol Tool has a useful section under Safety Monitoring and Adverse Events and RCT Management: http://www.globalhealthtrials.org/site_media/media/articles/trialprotocoltool/TrialProtocolTool.html
7. A useful SOP on trial monitoring including a risk assessment for determining the level of monitoring required: http://workspace.imperial.ac.uk/clinicalresearchgovernanceoffice/public/JRO%20SOP%20015%20Monitoring%20Controlled%202010.pdf
8. SOP on Auditing , although please bear in mind this is UK University specific: http://workspace.imperial.ac.uk/clinicalresearchgovernanceoffice/public/JRO%20SOP%20018%20Audit%20Controlled%202010.pdf
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