Blinding/Unblinding

Q: Do I need to be blinded assessor for OPTIMAS outcomes? A: We ask sites to make every effort to ensure that outcome assessors are unaware of treatment allocation when collecting 90-day follow-up. If there are any issues, please speak to your lead Trial Practitioner or Manager. NB: At the moment we are in the process of changing the setting in Sealed Envelope online randomisation system so that the team who have an account will not receive an email notification of the treatment allocation.

Q: Do I need to be blinded assessor for OPTIMAS outcomes? A: We ask sites to make every effort to ensure that outcome assessors are unaware of treatment allocation when collecting 90-day follow-up. If there are any issues, please speak to your lead Trial Practitioner or Manager. NB: At the moment we are in the process of changing the setting in Sealed Envelope online randomisation system so that the team who have an account will not receive an email notification of the treatment allocation.

Q: We understand that the 90-day follow-up needs to be collected by an unblinded assessor, however what about the Outcome Events? A: The person completing the Outcome Events does not need to be blinded. However, please ensure that the person collecting the 90-day follow-up is NOT the same as the person collecting the Outcome Event.

Q: In relation to assessments of SARs, SAEs and outcome events which we become aware of between discharge and 90 days, does the person gathering this information need to be blinded to the treatment allocation?  I am not sure how this would work given that the PI needs to sign of the SAR forms. A: The person completing the SAE/SAR/Outcome Event forms does not need to be blinded. But please ensure that the person collecting the 90-day follow-up is NOT the same as the person completing these forms.