Randomisation Envelope Supplies Form: Ambulance service research teams

Please complete this form to confirm receipt of and report missing/damaged randomisation envelopes from Warwick Clinical Trials Unit to Ambulance Service research teams.

Name of receiving ambulance service

Start (lowest) participant ID

End (highest) participant ID

Date received

Received by (Ambulance service research staff name)

Date checked

Checked by (Ambulance service research staff name)

List of participant IDs where envelope is missing

List of participant ID’s where envelope is damaged/tampered with. Please note: damaged/tampered is defined by the ambulance services where envelopes are no longer useable e.g. soiled by liquids / red tape on seal has been removed with void visible / able to see treatment allocation through envelope

Please provide details on level of damage to envelopes

Please remember to record all damaged envelope participant ID numbers on the ‘Randomisation Envelope Destruction Log’.

After submitting this form an alert will be sent to the PARAMEDIC-3 trial team. Please await a response from the trial team prior to destroying damaged/tampered envelopes.

Privacy notice

This form will only be used to monitor the receipt of randomisation envelopes from Warwick CTU to ambulance service research teams for the PARAMEDIC-3 trial.

The University of Warwick is the Data Controller of any information you have entered on this form and is committed to protecting the rights of individuals in line with Data Protection Legislation. The University's Data Protection webpages provide further information on your rights and how the University processes personal data. If you wish to submit a data subjects rights request, make a complaint or report a suspected personal data breach, please contact the University’s Data Protection Officer by email at infocompliance@warwick.ac.uk.

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