Develop Pharmacovigilance / Safety Reporting Plan

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.

Useful resources:
1. http://www.globalhealthtrials.org/articles/safety-reporting/
2. http://www.globalhealthtrials.org/community/blog/post/mamulla/2010/09/adverse-event-reporting/
3. http://www.cttoolkit.ac.uk/route_maps/stations.cfm?current_station_id=293&view_type=map
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
6. http://workspace.imperial.ac.uk/clinicalresearchgovernanceoffice/public/JRO%20SOP%20001%20Safety%20Reporting%20Controlled%202010.pdf

To return to the Global Health Research Process Map click the following link:
https://processmap.tghn.org/

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.