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National Coordinating Investigators
Newsletter No. 2
Dear National Coordinating Investigators,
Welcome to the second edition of the Garfield VTE Newsletter. As of the first week in June, we have recruited
1074 patients globally.
June, 2015
We are pleased to share with you the preliminary baseline results on patient characteristics, planned
treatment, prior treatment and risk factors for the first 1,000 patients:
Global News
and Announcements
The first publication on the Garfield VTE study is planned for
the first quarter of 2016 and we hope to include as many
patients as we can in the analysis. In order to have meaning-
ful results from each country, we will need to have at least
cohort 1 completed by December 2015. Your help in en-
couraging the sites in your country to achieve this will be
much appreciated.
Some countries have already started to organise local
meetings by teleconference to identify barriers to enrol-
ment. We will be contacting you shortly to discuss the feasi-
bility and logistics of these local meetings in your country. In
addition, as summer is approaching in most countries, many
site personnel are planning their summer vacation. Please
remind the sites to ensure that there is sufficient cover at
the sites to ensure that enrolment is not adversely impacted
during these few months.
Project Team at TRI
Gloria Kayani (Chief Operating Officer), Pearl Kho (Global Project Manager), Richard Coles (Regional Project
Manager, Americas, Asia), Elizabeth Demmisse (Regional Project Manager, EMEA), Sofia Fernandez
(Research Coordinator, UK, France, Spain), Luz Angela Gomez (Clinical Trial Administrator).
GARFIELD-VTE Newsletter no. 2 June 2015
www.tri-london.ac.uk
GARFIELD-VTE – Recruitment in France
0
100
200
300
400
500
600
Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15
Target Projected Actual
Total recruited =
366
300
183
Target = 300
Clarification of Inclusion and Exclusion Criteria:
(1) Patients who have a short life expectancy, for example, less than 6 months should be excluded (2) Patients who have been treated for previous AF rather than VTE should be excluded
Study Timelines
Global recruitment is currently behind target, all efforts should be made to ensure that at least Cohort 1 is completed by December
Electronic Data Capture System (Clinpal)
On-line tutorial will be available in July to familiarise users with the system Project Team at TRI
Gloria Kayani (Chief Operating Officer), Pearl Kho (Global Project Manager), Richard Coles (Regional Project Manager, Americas, Asia), Elizabeth Demmisse (Regional Project Manager, EMEA), Sofia Fernandez (Research Coordinator, UK, France, Spain), Luz Angela Gomez (Clinical Trial Administrator).
Site Recruitment
GARFIELD-VTE Newsletter no. 2 June 2015
France Status
Target number of sites 25
Number of sites Invited 271
Number of Sites Expressed an Interest 26
Number of completed FQs 22
Sites selected 20
CCTIRS and CNOM Submission 04 May 015
CNIL Submission 08 Jun 2015
Approval August 2015
CTA fully executed 0
SIV completed First SIV Estimated August/September
2015
Sites recruiting 0
First Patient First Visit Estimated September 2015
GARFIELD-VTE Newsletter no. 2 June 2015
Site # PI Name Date of
CCTIRS &
CNOM Sub-
mission
Estimated
Date of
Approval
Estimat-
ed CNIL
Submis-
sion
Estimat-
ed Date
of Ap-
proval
Date Con-
tract sent
to site
Estimate
Date Con-
tract Fully
Executed
SIV Date
(Estimat
e)
Private Practice, Lyon Addala Azeddine 04-May-15 01-Jul-15 01-Jul-15 Aug-15 27-May-15 30-Jun-15 Aug-15
Centre Hospitalier, Annecy
Genevois
Berremeli Toufek 04-May-15 01-Jul-15 01-Jul-15 Aug-15 12-May-15 31-Jul-15 Aug-15
Private Practice, Sarrebourg Bosler Frédéric 04-May-15 01-Jul-15 01-Jul-15 Aug-15 12-May-15 30-Jun-15 Aug-15
Groupe Hospitalier De L'uni-
versité Catholique De Lille
Chevrier Elisabeth 04-May-15 01-Jul-15 01-Jul-15 Aug-15 12-May-15 31-Jul-15 Aug-15
Hopital Saint André, Bordeaux Constans Joël 04-May-15 01-Jul-15 01-Jul-15 Aug-15 07-May-15 31-Jul-15 Aug-15
L'hôpital De La Cavale
Blanche Du Chru De Brest
Couturaud Francis 04-May-15 01-Jul-15 01-Jul-15 Aug-15 27-May-15 31-Jul-15 Sep-15
Centre Hospitalier Universi-
taire Nantes
Dominique Elkouri 04-May-15 01-Jul-15 01-Jul-15 Aug-15 Sep-15
Centre Hospitalier Universi-
taire Dijon
Falvo Nicolas 04-May-15 01-Jul-15 01-Jul-15 Aug-15 22-May-15 31-Jul-15 Sep-15
Centre Hospitalier Universi-
taire De Nice
Ferrari Emile 04-May-15 01-Jul-15 01-Jul-15 Aug-15 22-May-15 31-Jul-15 Sep-15
Clinique Monié, Villefranche
de Lauragais
Garrigues Damien 04-May-15 01-Jul-15 01-Jul-15 Aug-15 12-May-15 30-Jun-15 Sep-15
Centre Hospitalier Universi-
taire Lyon
Grange Claire 04-May-15 01-Jul-15 01-Jul-15 Aug-15 Sep-15
Private Practice, Perpignan Grare Frédérick 04-May-15 01-Jul-15 01-Jul-15 Aug-15 12-May-15 30-Jun-15 Sep-15
Centre Hospitalier De Bayeux Guillot Jean-Paul 04-May-15 01-Jul-15 01-Jul-15 Aug-15 12-May-15 31-Jul-15 Aug-15
Centre Hospitalier Universi-
taire Lyon
Helene Desmurs-
Clavel
04-May-15 01-Jul-15 01-Jul-15 Aug-15 Sep-15
Centre Hospitalier Départe-
mental Vendée
Kubina Jean-
Manuel
04-May-15 01-Jul-15 01-Jul-15 Aug-15 12-May-15 31-Jul-15 Sep-15
Centre Medical, Medipole,
Toulouse
Laroche Jean-
Pierre
04-May-15 01-Jul-15 01-Jul-15 Aug-15 12-May-15 31-Jul-15 Oct-15
Hopital Louis-Mourie, Co-
lombes
Mahe Isabelle 04-May-15 01-Jul-15 01-Jul-15 Aug-15 12-May-15 31-Jul-15 Sep-15
Private Practice, Annecy Martin Myriam 04-May-15 01-Jul-15 01-Jul-15 Aug-15 07-May-15 30-Jun-15 Oct-15
Centre Hospitalier Universi-
taire Nantes
Matheiu Artifoni 04-May-15 01-Jul-15 01-Jul-15 Aug-15 Aug-15
Centre Apolline, Private Prac-
tice, Narbonne
Mersel Tahar 04-May-15 01-Jul-15 01-Jul-15 Aug-15 12-May-15 30-Jun-15 Oct-15
Private Practice, Grenoble Peuch Bernadette 04-May-15 01-Jul-15 01-Jul-15 Aug-15 12-May-15 30-Jun-15 Oct-15
Centre Hospitalier Universi-
taire De Grenoble
Seinturier Chris-
tophe
04-May-15 01-Jul-15 01-Jul-15 Aug-15 12-May-15 31-Jul-15 Oct-15
Centre Hospitalier Universi-
taire Amiens
Sevestre-Pietri Ma-
rie-Antoinette
04-May-15 01-Jul-15 01-Jul-15 Aug-15 20-May-15 31-Jul-15 Aug-15
Hopital Civil de Strasbourg Stephan
Dominique
04-May-15 01-Jul-15 01-Jul-15 Aug-15 12-May-15 31-Jul-15 Oct-15
Centre Hospitalier Universi-
taire Le Bocage
Terriat Béatrice 04-May-15 01-Jul-15 01-Jul-15 Aug-15 07-May-15 31-Jul-15 Oct-15
Site Regulatory Start-up
