Develope pharmacovigilance / safety reporting plan
If your study is using an investigational medical product (IMP) you should develop a plan for reporting of adverse events and reactions. Details of the IMP should be included in the protocol but you should also make sure expected averse events are identified and the procedures for reporting unexpected and expected adverse events are outlined. It will be helpful to do this in conjunction with the risk assessment and quality assurance plan.
4. The Trial Protocol Tool has a useful section under Safety Monitoring and Adverse Events: http://www.globalhealthtrials.org/site_media/media/articles/trialprotocoltool/TrialProtocolTool.html
5. Templates and guidelines on Safety Reporting: http://www.admin.ox.ac.uk/rso/clinical/downloads.shtml#SOPwriting
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