SUSAR Reporting for blinded studies

[ZYunus]

Would you be able to clarify the mechanism for reporting for blinded studies? My understanding is that before reporting a SUSAR to the MHRA, it will have to be unblinded by the sponsor, questions arising from this are:
- Who should remain blinded at the sponsor site (eg study co-ordinator, monitor, trial statistician, data manager)?
- If the study co-ordinator is to remain blinded is it advisable to arrange for an independent co-ordinator to complete SUSAR reporting?
- If the trial statistician is to remain blinded, I presume he shouldn't be attending the closed meetings for the DMC?
- Should the DMC members have access to unblinded data for all patients recruited or only for SUSARs?
- How should SUSARs be reported to investigators at sites? What information should the line listings contain for a blinded study so as not to unblind all the investigators?

Many thanks

[dch]

Please refer to the recent guidance at http://ec.europa.eu/health/files/eud...c172_01_en.pdf, section 7.11. You should get all your questions answered.

Kind regards