8/9/2019 EMPiRE Newsletter Feb'15
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EMPiREnewsletter
Feb 15
..Brrrr! Its Cold this winter and the
excitement of Christmas festivities
and New Year are now a distant
memory... But wait, try to resist the
strong urge to hibernate we have some
excellent news to share with you! The
HTA have approved our request of an
extension until March 2016 so that
the follow up of all participantscan be carried out.
Good News!
Please note
Participant DiariesWell done to those sites
who have managed to
enter all their data so
far! With recruitment
now over we cant
stress enough justhow important it is to
complete all data entry.
We will award M&S
vouchers to each site as
a thank you for entering
all data and resolving all data
queries. We have already
started to raise data queries, so
please be prepared to respond
to them in good time.
Data Entry
Please ensure that once data entry is complete
for a participant that you indicate whether they
are complete or discontinued in the electronic
PIDF section, so that we have a better idea of
how fabulous you all are at completing your data
entry! Please also ensure that electronic SAE
forms are also entered.
Any database related problems and questions
should either be directed to the coordinating
midwife for your site or to Sian Newton who is
temporarily coordinating the study.
Sians Email: [email protected] [email protected]
Please continue to regularly send copies of your
EMPiRE diairies to Maria DAmico at the trial
ofce:
Womens Health Research Unit
Centre for Primary Care & Public HealthBlizard Institute
Barts and The London School of Medicine and
Dentistry
Yvonne Carter Building
58 Turner Street
London E1 2AB
Please also remember to recycle any blank CRFs
you may have left over.
mailto:s.newton%40qmul.ac.uk?subject=mailto:s.newton%40qmul.ac.uk?subject=
8/9/2019 EMPiRE Newsletter Feb'15
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EMPiREnewsletter
The trial ofce will eventually be in contact withthose sites for
which we are missing documents
for. We kindly ask you all to update and organise
the contents of your investigator site les now,so that when it
is time to close your site down the
process will be a lot quicker and more efcient.
Once a site has followed up all their patients
and completed data entry, we are able to
begin the close down process for that site. A
teleconference will be arranged to go through
the EMPiRE close down checklist.
A new version of SOP 2 Data management hasbeen circulated to all
sites. Please ensure that
the relevant personnel sign and le in the ISF.
.the Womens Health Research Unit at QMUL
(trial ofce) are on Twitter! If youre not alreadyfollowing to
receive regular updates and
encouraging tweets about EMPiRE, please look
for @KT_Network.
Just a reminder that transport expense claims for
participants must be received by the trial ofce
within 3 months from the purchase date. Expenses
that exceed the 3 month period will not be able to
be reimbursed so please ensure expenses are sent as
soon as possible.
DX boxes
Epilepsy
Empire
Seizures
Database Patients
Diaries
Polytherapy
Randomisation
Carbamazepine
Pregnancy
Midwife Tonic Clonic
Serum levels
Site Close Down
SOP 2 Data Management
Did you hear...?
Expenses
Crossword Answers
Feb 15
