|| Home||| Journal||| Directories||| Resources||| MAGI||| About Us||| Contact Us||| Sign In||| Sign Up|
EC Guideline – Serious Adverse Event Reporting for Medical Devices
7.2 Report by the investigator to the sponsor
8. REPORTING FORMThe reporting form template for the summary SAE tabulation is given in the Appendix of this document.
The table gives a cumulative overview of the reportable events per clinical investigation and will be updated and transmitted to participating NCAs each time a new reportable event or a new finding to an already reported event is to be reported. More detailed information has to be provided on request of an NCA.
The sponsor shall identify the new/updated information in the status column of the tabular form featured in the Appendix as:
a = added = new reportable event;Changes in a line should be highlighted in bold and/or color in the respective column.
The reporting form is study specific and covers only a given clinical investigation, defined by a distinct clinical investigation plan. English is the recommended language for the reporting form. The report should be sent by email preferably in Excel or equivalent format to the participating NCAs.
REFERENCES:1. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, last amended by Directive 2007/47/EC.
2. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, last amended by Directive 2007/47/EC.
3. ISO/FDIS 14155:2010 Clinical investigation of medical devices for human subjects – Good clinical practice
APPENDIX – REPORTING FORMMEDDEV 2.7/3 SAE Report Table- V1
|© 2003-2012 First Clinical Research LLC. Trademark Notice Terms & Conditions Privacy Statement Site Map|