Site Tracker Update

We are making updates to the study logs included on the Site tracker in coming weeks. We will notify sites when this goes live.

Planned changes are highlighted below.

1) Screening log - NEW

A separate screening log has been added to the Site tracker. Sites should include potential participants who meet the inclusion criteria in the trial and have been approached about taking part in the trial. Our Trial Steering committee has requested this be monitored.

2) Enrolment and Randomisation log

Minor edit to Recruitment status options.

A new column has been added to the Enrolment and Randomisation log, to document ‘Reason for withdrawal’.

3) File Note log

No changes

4) Deviation log

Two new columns have been added to the Deviation log, ‘Event type’ and ‘Category’ to align with Sponsor updates to Non-Compliance reporting.

5) Safety event log

Minor correction to title of first column on the Safety event log.

We will circulate the updated Site tracker alongside the upcoming amendment and provide clear instructions on transfer of information to new log and storage of information on previous log.