E-Newsletter December 2015

Month PatientsJan 20Feb 20Mar 25Apr 24

May 29Jun 49Jul 36

Aug 18Sep 31Oct 38

Nov 25

Outcome DataAs we come to the end of recruitment the focus is on outcome and follow up data.

It is essential we receive all patients Final Report: Trial Exit forms.If a patient decides not to continue the trial sites still need to follow them up at 12 months after randomisation to collect outcome data. If you cannot contact the patient please contact the GP to find out if the patient became pregnant.Do not use the “other” box we need a true outcome for all trial participants.

Thank youOn behalf of the TABLET team we would like to thank all of you

for the hard work and dedication you have put into this trial.Please do keep up the good work as there will be a number of

queries and follow up forms to complete.

New DocumentsDelegation log and Prescription Form

We are now using delegation log V3.1 and prescription form V4.0.This is a new log and should only be signed off by staff currently working on TABLET.

This should NOT be back dated in any way as this is a current log.A separate log doesn’t need to be completed for pharmacy and research teams they can be on same but if they are separate we need both and so does the site file at the

Hospital.

A clinician (Medical Doctor) should confirm all eligibility for TABLET study. Research nurses and midwives can confirm eligibility for prevalence but must make this

clear on the delegation log.

Recruitment end dates

Screening will end 31/12/15.Randomisations will end 22/01/16.