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May 14
Well done to everyone who
recruited in May. We hit
our target and recruited a
total of 469 by the end of
April 2014. This is a fantastic
achievement! Thank you for all
your hard work.
Please keep recruiting! We will keep
you updated about HTAs response
to our extension request which we
submitted on the 15th May 2014.
We are continuing to
roll out the database to
EMPIRE sites and will
contact you shortly, if we
have not done so already.
Many thanks for your
continued support with
Below (Page 3) is a list
of Frequently Asked
Questions that you
might fnd useful. If you are
unable to fnd an answer to
your question in this list please
remember to contact one of the
The Womens Health Research Unit at QMUL
(trial offce) re-launched their twitter account on
Monday 20th May 2014 to coincide with Clinical
Trials Day.
Please follow @KT_Network to view tweets
about EMPiRE and other trials the Womens
Health Research Unit are involved in.
EMPiRE and Twitter
To ensure the effcient processing of these
documents please ensure that the following
people are copied in to the email when you send
recruitment and blood request forms from your
secure email account:
Maria will also be sending purple alerts, non-
adherence and follow-up notifcations to you.
Please ensure that copies of your EMPiRE diaries
are now sent to Maria DAmico at the following
Womens Health Research Unit
Centre for Primary Care and Public Health

Blizard Institute
Barts and The London School of Medicine
and Dentistry
Yvonne Carter Building
58 Turner Street
London E1 2AB
We would appreciate if this can be done
frequently, preferably after each clinic, however,
if this is not possible at least every 2-3 months.
If you have not done so already please ensure that
the completed signature pages of all current SOPs
are faxed to Malika on 020 7882 6047:

All SOPs should be signed by appropriate members
of your local research team.
Recruitment & Data Request Forms
Participant Diaries
Standard Operating Procedures (SOP)
front covers
SOP 1 Informed Consent Version 4 17.03.13
SOP 2 Data Management Version 1 07.09.12
SOP 3 Blood Collection & Processing Version 3 11.10.13
SOP 4 Adverse Event & Serious
Adverse Event Reporting
Version 3 30.07.12
SOP 5 Monitoring Version 3 02.05.13
SOP 6 Training Version 1 16.07.12
SOP 7 Randomisation & Unblinding
Notifcation procedure
Version 1 23.04.13
SOP 8 Data quality check for sites Version 2 15.05.13
May 14
May 14
You can either use Internet Explorer 8 or Google
Chrome. If you do not have either of these
installed on your PC please contact your local IT
team to see if they can help with this.
You should enter the date of delivery NOT the
date the booklet was completed.
We only require a whole number to be entered
here so please round it to the nearest whole
We only require you to enter the current feeding
method at the Post natal Visit.
Please enter the date as NK/NK/NK and then
ensure the following question at the bottom of
the page is marked as No:
You use the Save if the form has missing
information which you need to obtain and enter
later on. Saving and Validating the form means
that it is complete and there is no other data to
be entered. Saving and Validating the form does
not mean it is locked. You can still amend the
data if necessary.
You can document RDA in the text box where
you enter what the medication is and then still
put 999999 in the dosage feld.
Click Yes to data collected and then select
N/A by the purple alert question.
Which browser should I use to open the
What date should be entered for the
visit date in the Delivery Booklet?
The database will not accept 35.5(cm)
as a baby head measurement in the
Delivery Booklet on page 3.
For the question current method of
feeding on Page 1 of the Post Natal
Booklet, if bottle is selected, then it
doesnt allow the feld for number of
weeks breast fed to be flled in. This
particular patient breast fed briefy
between birth and the post natal check.
How should we enter this?
One of our participants remained on
the same dose after delivery up until
postnatal, but page 2 of the Post Natal
Booklet requests a date of dose change
under the Current AED section and I
cant leave it blank.
What is difference between Save and
Save and Validate?
The participant is taking a multivitamin
tablet OR Pregnacare. We do not know
the dose she is taking in the values
specifed. What should we enter?
On the fnal page of each Antenatal
Follow-Up booklet is the question which
is only completed if a purple alert has
been received in the paper version. What
should be entered for this page on the
database if there has not been a purple
alert issued?
Calculating recruitment rate according to birth numbers at each unit:
You get**15 in M&S gift vouchers**
and members of your research team will
soon receive a certifcate acknowledging
your hard work for the month. Keep an eye
on your post. Everyone else, keep at it, next
month it could be you!
The Best Recruiter in April was:
PI: Dr Fady Alfaily
Research Midwife: Aine Turner
Followed by Leeds General Infrmary (2nd place)
& Royal Hampshire County Hospital (3rd place)

Congratulations, Great Work!
Colchester General Hospital
May 14
Approved Centre Name Date Site Opened Total
1 Birmingham Womens Hospital 4-Nov-11 44
2 Queens Hospital, Romford 8-May-12 22
3 St Tomas Hospital 04-Jan-12 21
4 Liverpool Womens Hospital 5-Jan-12 20
5 Newcastle Royal Infrmary 3-Feb-12 20
6 Royal Hallamshire Hospital 4-May-12 20
7 St Richards Hospital 20-Apr-12 17
8 St Georges Hospital 9-May-12 16
9 Singleton Hospital, Swansea 13-Jul-12 14
10 Glan Clwyd Hospital 28-Feb-13 14
11 Staford Hospital 6-Jan-12 13
12 Royal Victoria Hospital, Belfast 1-Feb-13 12
13 Royal Blackburn Hospital 17-Nov-11 11
14 Colchester General Hospital 4-Jun-13 11
15 Sunderland Royal Hospital 18-May-12 10
16 Southampton General Hospital 20-Sep-12 10
17 Southend Hospital 20-Jul-12 9
18 Te Royal Derby Hospital 10-Sep-12 9
19 Worcester Royal Hospital 12-Sep-12 9
20 Chelsea & Westminster 22-Feb-13 9
21 Leeds General Infrmary 13-Mar-13 9
22 University Hospital of North Stafordshire 12-Jun-12 9
23 Birmingham City Hospital 6-Sep-12 8
24 Royal Gwent Hospital, Newport 21-Sep-12 8
25 Southern General Hospital, Glasgow 17-May-13 8
26 John Radclife Hospital 24-Jul-13 8
27 Newham University Hospital 5-Jul-12 7
28 St Marys Hospital/Salford Hospital 26-Sep-12 7
29 Royal Shrewsbury Hospital 21-Nov-12 7
30 Leicester Royal Infrmary 31-Jan-13 7
31 Burnley General Hospital 22-Apr-13 7
32 Royal Hampshire County Hospital 24-Apr-13 7
33 University Hospital Wales 30-Mar-12 6
34 Te Royal London 16-May-12 6
35 Coventry & Warwickshire 14-Jan-14 6
May 14
NB: Figures above do not include those recruited to qualitative study only or those enrolled in error
click here to visit our website >><<
EMPiRE Co-ordinating
Research Midwife for
North England,
& Wales
Email: elizabeth.quinlan-
Tel: 07826 512490
EMPiRE Co-ordinating
Research Nurse for
South England
Email: MunN.Lim@
Tel: 07771 974713
EMPiRE Trial Co-
Womens Health
Research Unit
Email:r.a.rikunenko@ email: rachel.
Mobile: 07917 736924
Fax: 020 7 882 6047
EMPiRE Co-Ordinating
Research Midwife for
Mobile: 07936 436 900
Tel: 0131 242 2667
Approved Centre Name Date Site Opened Total
36 Bradford Royal Infrmary 19-Dec-12 5
37 Frimley Park Hospital 16-Jan-13 5
38 Royal Sussex Hospital 5-Feb-13 5
39 Royal Cornwall 13-May-13 5
40 University Hospital North Durham 25--May-12 5
41 Warrington Hospital 24-Jun-13 4
42 Worthing Hospital 30-Apr--12 4
43 Nevill Hall Hospital, Abergavenny 21-Sep-12 3
44 Whipps Cross Hospital 10-Jan-13 3
45 Queen Alexandra Hospital, Portsmouth 23-May-13 3
46 Gloucester Royal Hospital 12-Apr-13 2
47 Northampton 19-Apr-13 2
48 Edinburgh Royal Infrmary 11-Jul-13 1
49 North Middlesex 24-Oct-13 1
50 Basingstoke & North Hampshire Hospital 24-Apr-13 0
May 14
EMPiRE Data Assistant
Womens Health
Research Unit
Tel: 020 7882 6695
Fax: 020 7882 6047