References: (2011/C 172/01) Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (CT-3). Version 11.6.2011 ICH Harmonised Tripartite Guideline: Development Safety Update Report E2F current Step 4 – version dated 17th August 2010 DSUR Examples Non-commercial Sponsors: at time of writing Acknowledgements: The first version of this document has been based on the equivalent Cancer Research UK Clinical Trials Unit document with feedback from the Birmingham Clinical Trials Unit, the Primary Care Clinical Research and Trials Unit, and the UHB R&D department. We would like to thank all staff members within the CTUs and UHB R&D who have been involved in developing these documents for their time and efforts. .
References: (2011/C 172/01) Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (CT-3). Version 11.6.2011 ICH Harmonised Tripartite Guideline: Development Safety Update Report E2F – current Step 4 version dated 17th August 2010 DSUR Examples Non-commercial Sponsors: at time of writing Acknowledgements: The first version of this document has been based on the equivalent Cancer Research UK Clinical Trials Unit document with feedback from the Birmingham Clinical Trials Unit, the Primary Care Clinical Research and Trials Unit, and the UHB R&D department. We would like to thank all staff members within the CTUs and UHB R&D who have been involved in developing these documents for their time and efforts. .
UoB-CLN-QCD-002-DSUR-template-v-1-0-for-circulation-doc.docx