Deaths – UEA co-ordinating centre processes flowchart

UEA co-ordinating centre receives notification of randomised participant death from NHS IC

SOP04-App4v v2.2 19Aug09

UEA co-ordinating centre to advise relevant study centre of death by email. Standard email to contain following details:-

•Deceased participant’s [TrialCode] and initials

•Date of death

•Text from NHS IC death notification for study centre to insert at start of [Notes] field on Death record on SCOOP database (Dates UEA and study centre informed of death, initials of study team member entering data, cause(s) of death, place of death)1.

(see SOP04 Appendix 4v PART B, section d) i)

END

UEA co-ordinating centre submits details of randomised participants to NHS Information Centre (NHS IC) for

flagging on NHS central register

Notes:-

1. If UEA co-ordinating centre receives notification of death from NHS IC after study centre is notified by another source, a Death record will have already been created by the study centre. In these cases the study centre to add further details to Death record from NHS IC notification.

Original of NHS IC death notification to be retained by UEA in central deaths file, in [TrialCode] order

How is UEA notified of death? NHS IC

UEA checks relevant data source file (eg. SPIDRPTD.csv returned by relevant GP practices annually as part of patient status and medication data searches, or HES return etc) vs SCOOP d/b

UEA adds relevant [SourceOfInformation] etc, plus note regarding source of death report (eg. from HES return or SPIDRPTD.csv file)

Death record exists on SCOOP database?

UEA to advise relevant study centre of death by email. Standard email to contain following details:-

•Deceased participant’s [TrialCode] and initials

•Standard text for study centre to add to [Notes] section

•Request for study centre to contact GP practice to obtain date of death, where relevant.

END

Yes No

Other (eg. Miquest pt status & meds data, HES return etc)