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 Spain

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

500

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

Spain Status

Target number of sites 20

Number of sites Invited 105

Number of Sites Expressed an Interest 29

Number of completed FQs 29

Sites selected 20

R&D/EC submission done 12

R&D/EC approved 3

CTA fully executed 1

SIV completed 1

Recruitment Target 300

First Patient First Visit Estimated June 2015

GARFIELD-VTE Newsletter no. 2 June 2015

Site Name PI Name Estimated

Date of

Submission

Date of

Submission

Meeting

Date

(Projected)

Estimated

Date of

Approval

Date of

Approval

First Site

Contract

Draft Creat-

First Site Con-

tract Final

Sent to Site

Estimated

Date Con-

tract Fully

SIV Date

H. Trias I Pujol Manuel Monre-

al Bosch

1-5 may

2015

01/May/15 11/May/15 29/May/15 17/May/15 N/A 01/May/15 12-Jun/2015 Jun-15

H Santa Creu I

Sant Pau

Juan Carles

Souto

1-5 may

2015

04/May/15 25/May/15 29/May/15 Pending 22/Apr/15 27/Apr/15 12-Jun/2015 Jun-15

H Vall D'Hebron Josep Suriñach

Caralt

1-5 may

2015

01/May/15 25/May/15 29/May/15 Pending N/A 01/May/15 12-Jun/2015 Jun-15

H Ramon y Cajal David Jiménez 1-5 may

2015

04/May/15 25/May/15 29/May/15 Pending 08/05/15 15/05/15 12-Jun/2015 Jun-15

H Provincial

Reina Sofia

Lucian López-

Jiménez

1-5 may

2015

01/May/15 25/May/15 Unknown Pending 15/05/15 TBC 30-Jun-2015 Jul-15

H El Vendrell David Riesco

Acevedo

1-6 June

2015

TBC 25/Jun/15 30/Jun/15 TBC 20/May/15 20/May/15 12-Jul-2015 Jul-15

H. Trueta Ferran García-

Bragado

Dalmau

1-6 June

2015

TBC 25/Jun/15 30/Jun/15 TBC Pending Pending 12-Jul-2015 Jul-15

H. Infanta Mar-

garita

Raimundo

Tirado Miranda

1-6 June

2015

TBC 25/Jun/15 30/Jun/15 TBC Pending Pending 12-Jul-2015 Jul-15

Hospital Univer-

sitario de Gran

Canaria Dr.

Negrín

Oscar, Sanz 1-6 June

2015

TBC 25/Jun/15 30/Jun/15 TBC Sent for

translation

22/05/15

Pending 12-Jul-2015 Jul-15

H. Universitario

Madrid Norte

Sanchinarro

Bárbara Pagán 1-6 June

2015

TBC 25/Jun/15 30/Jun/15 TBC Pending Pending 12-Jul-2015 Jul-15

H Virgen Mac-

arena

Juan Carlos

Álvarez Benítez

1-6 June

2015

TBC 25/Jun/15 30/Jun/15 TBC Pending Pending 12-Jul-2015 Jul-15

Hospital Parc

Sanitari Sant

Joan de Deu

Pablo Javier

Marchena

1-6 June

2015 (for

secondary

CEIC)

TBC 25/Jun/15 30/Jun/15 05/05/15

pending

Secondary

CEIC aprov-

Pending Pending 30-Jun-2015 Jul-15

Hospital Vega

Baja

M. Lorente 1-6 July

2015

TBC TBC TBC TBC TBC TBC 12-Jul-2015 Sep-15

Hospital Clínico

Universitario de

Santiago

J. Díaz 1-6 July

2015

TBC TBC TBC TBC TBC TBC 12-Sep-2015 Sep-15

Hospital General

Univ. Gregorio

Marañón

Jorge del Toro 1-6 July

2015

TBC TBC TBC TBC TBC TBC 12-Sep-2015 Sep-15

Hospital Reina

Sofía de Tudela

Angel Sampériz

legarre

1-6 July

2015

TBC TBC TBC TBC TBC TBC 12-Sep-2015 Sep-15

Hospital Virgen

del Rocío

Remedios

Otero

1-6 July

2015

TBC TBC TBC TBC TBC TBC 12-Sep-2015 Sep-15

Hospital Univer-

sitario de Bell-

vitge- Idibell

Antoni Riera-

Mestre

1-6 August

2015

TBC TBC TBC TBC TBC TBC 12-Oct-2015 Sep-15

Hospital Sier-

rallana

Reina Valle 1-6 August

2015

TBC TBC TBC TBC TBC TBC 12-Oct-2015 Oct-15

Hospital Univer-

sitario La Fe

Raquel López-

Reyes

1-6 August

2015

TBC TBC TBC TBC TBC TBC 12-Oct-2015 Oct-15

Hospital General

Univ. de Alicante

Luis Manuel

Hernández

Blasco

1-6 August

2015

TBC TBC TBC TBC TBC TBC 12-Oct-2015 Oct-15

Hospital Sant

Joan Despí-

Moisés Broggi

Esther Usandi-

zaga

1-6 August

2015

TBC TBC TBC TBC TBC TBC 12-Oct-2015 Oct-15