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National Coordinating Investigators Newsletter No. 2 Dear National Coordinating Investigators, Welcome to the second edion of the Garfield VTE Newsleer. As of the first week in June, we have recruited 1074 paents globally. June, 2015 We are pleased to share with you the preliminary baseline results on paent characteriscs, planned treatment, prior treatment and risk factors for the first 1,000 paents: Global News and Announcements The first publicaon on the Garfield VTE study is planned for the first quarter of 2016 and we hope to include as many paents 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 meengs by teleconference to idenfy barriers to enrol- ment. We will be contacng you shortly to discuss the feasi- bility and logiscs of these local meengs in your country. In addion, as summer is approaching in most countries, many site personnel are planning their summer vacaon. 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 Operang 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).

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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