GARFIELD-VTE South Africa...• Updated Event folder • Treatment Page –Other Treatments •...
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GARFIELD-VTE South Africa Investigators’ Meeting Johannesburg, 28 th October 2017
Transcript of GARFIELD-VTE South Africa...• Updated Event folder • Treatment Page –Other Treatments •...
GARFIELD-VTE
South Africa
Investigators’ Meeting
Johannesburg, 28th October 2017
Operational Priorities and
South Africa Status Update
Elizabeth Demmisse
Regional Project Manager
Thrombosis Research Institute
Operational Priorities
Follow up- Data entry Recent eCRF Update Query Status Payment process/updatePatient retention update and processCommunication- WebsiteSouth Africa specific Challenges- for discussion
South Africa Status Update
South Africa Enrolment Status
National Coordinator Investigator:
Prof Barry Jacobson Dr Clifford Smith
National Care Setting:
Smaller private hospitals/ rehabilitation
clinics 14%
Other (private angiology practices) 53%
Large Hospitals / Academic facilities 33%
18 sites initiated and 14 active sites
416 patients recruited
8682
70
40
30 3026
1210 10 10
4 42
0
10
20
30
40
50
60
70
80
90
100
ZAF0079 ZAF0121 ZAF0102 ZAF0067 ZAF0061 ZAF0357 ZAF0063 ZAF0078 ZAF0065 ZAF0080 ZAF0322 ZAF0323 ZAF0355 ZAF0404
Total=416
South Africa - Patient Milestone
416 401 397364
175
15 1952
241
416 416 416 416
213
0 0 0
203
0
50
100
150
200
250
300
350
400
450
Baseline 3M 6M 12M 24M
Complete Incomplete Due Not due
South Africa-Query status
83
13 12 11 10 9 84 4 3 1
0
10
20
30
40
50
60
70
80
90
ZAF0121 ZAF0102 ZAF0065 ZAF0323 ZAF0079 ZAF0322 ZAF0357 ZAF0061 ZAF0355 ZAF0080 ZAF0078
Total=158
Recent eCRF UpdateExtra information• Update follow- up pages • Updated Event folder • Treatment Page – Other Treatments• Enhanced Recurrent VTE page• Other Updates• Messaging • Locking Milestones• Queries • ELearning/certificate• Library• Source Data Verification(*visible to monitors only)
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Recent System Update
Recent System Update
Recent System Update
South Africa Patient and Site Retention Status
How many sites initiated and activated? =18How many sites dropped before recruitment= 4How many patients recruited? =416 How many withdrawn?=114Withdrawal rate= 27.4%LTF= 11%
114
58
46
3
7
0 20 40 60 80 100 120
Total no. patienswithdrawn
death
LTF
Patients NLM
Withdraw Consent
South Africa Patient Withdrawn Status
Phase II - On-site Monitoring
Onsite Monitoring
will start end of October
Phase II
planning starts
Patient/site selection using risk
based score and random selection
Training CRA
Sites will be informed
Phase I Audit Report will be
available
Phase Start Date Cohort Countries *No. of Sites No. of cases
per site
Variables SDV’d Total Cases to
be SDV’d
1 Sep- 16 C1,C2 All, except **Brazil,
Mexico, UAE
42 (~10%) 6-10 100% SDV on first patient data
following by partial SDV (Critical
Variable)
400 (40%)
2 OCT- 17 C1,C2 All 32 (~7%) 6-10 partial SDV (Critical Variable) 300 (30%)
3 OCT- 18 C1,C2 All 32 (~7%) 6-10 partial SDV (Critical Variable) 300 (30%)
BioClinica (Clinverse) Contact details
• Sending Invoices to Bioclinica/Clinverse- Please DO NOT send Patients detail with Invoices
• Please send all Garfield VTE-related invoices directly to [email protected]• For questions about invoices and/or status of payments, you can access 24/7 support via
email at [email protected]• or via phone at 1-888-ASK-BIOC (1-888-275-2462). • Please Include these details in your email to [email protected]
Vendor Name: {enter Institution or PI name} Site: {enter USA#### where the first three letters are US code and #### is the
number} PI: {enter PI name]
Mailing Address: Bioclinica Financial Lifecycle Solutions 4505 Emperor Boulevard Suite 130 Durham, NC 27703
TRI and PIs: Support, expectations and collaborations
Engaged Responsive
Active
Collaboration
Pro-activeInspirational
Motivational
- Communication through Website
- Provide constant support/resources
- Regular Contact
- Newsletters
- Progress update
- Point of contact
TRI- Responsiveness to TRI operational team and CROs especially now on follow up
- Representatives of GARFIELD VTE & promote nationally
-be part of a large network of expert investigators in the field
- Access to the data for publication and presentations
- Contribute to Garfield-VTE data by completing follow up data
- Visit the website for the latest update, presentations and data
PIs
Global Operational
Priorities WorkshopLed by Dr Clifford Smith, Gloria Kayani and
Elizabeth Demmisse
Garfield-VTE Workshop
Discussion points• Data Query• Follow-up challenges• Physicians Villalta – 36 Months• Communication plan• Site Payments• Data Query resolution timeline• Website: http://vte.garfieldregistry.org/
Follow- Up Challenges • Patient Retention
• Lost to Follow up patients
• Is completing Patient questionnaires an issue?
• When do you declare patient is LTF?
• What is the plan to complete 24- 36 Months Physician Villalta?
• Challenges/Issues seeing patients during 24Montha to 36 months follow up period?
• What if the patient is not planned to be seen during this time?
• Can we invite the patient for visit?
• Challenges completing Patients Reported Questionnaires
• Any National Challenges?
South Africa - Patients Reasons for Withdrawal
1
17
10
1 1 3 1
8
16
1
22
6
1 1 1 1
4 4
1
0
5
10
15
20
25
Pat
ien
t n
o lo
nge
r m
eets
incl
usi
on
/exc
lusi
on
cri
teri
a
Pat
ien
t d
ied
Pat
ien
t lo
st t
o f
ollo
w-u
p
Pat
ien
t n
o lo
nge
r m
eets
incl
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on
/exc
lusi
on
cri
teri
a
Pat
ien
t d
ied
Pat
ien
t lo
st t
o f
ollo
w-u
p
Pat
ien
t w
ith
dre
w c
on
sen
t
Pat
ien
t d
ied
Pat
ien
t lo
st t
o f
ollo
w-u
p
Pat
ien
t w
ith
dre
w c
on
sen
t
Pat
ien
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ied
Pat
ien
t lo
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o f
ollo
w-u
p
Pat
ien
t d
ied
Pat
ien
t n
o lo
nge
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eets
incl
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on
/exc
lusi
on
cri
teri
a
Pat
ien
t w
ith
dre
w c
on
sen
t
Pat
ien
t d
ied
Pat
ien
t lo
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ollo
w-u
p
Pat
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t w
ith
dre
w c
on
sen
t
Pat
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t d
ied
ZAF0078 ZAF0079 ZAF0080 ZAF0102 ZAF0121 ZAF0323 ZAF0357 ZAF0404
Central venous catheter related thrombosis- South Africa vs Global
NO, 10075
NO, 413
YES, 98
YES, 2
0
2000
4000
6000
8000
10000
12000
Global South Africa
Missing Anticoagulants Data- South Africa vs Global
8555
1345
379
30
GLOBAL SOUTH AFRICA
Incomplete Data
Complete Data
South Africa- Anticoagulants Data Missing per Site
ZAF0322 ZAF0065 ZAF0102 ZAF0355 ZAF0080 ZAF0121 ZAF0323 ZAF0067
8
6
5
4
2 2 2
1
Characterisation of Distal and Proximal DVT- South Africa vs Global
7515
278
Global
Distal/Proximal datacomplete
Distal/Proximal datamissing
304
0
South Africa
Distal/Proximal datacomplete
Distal/Proximal datamissing
South Africa- Patient Questionnaires Status
0
50
100
150
200
250
300
350
Baseline 3 Months 6 Month 24 Month
153
101 89
21
48
7067
28
108
113108
55
0
118
025 45
87
Villalta
Withdrawn
Not reached
Not filled
Not done
Filled
Incomplete
0
50
100
150
200
250
300
350
400
450
Baseline 3 Months 6 Month 24 Month
132 113 120
29
137118 92
44
147
154145
80
0
150
031
59113
SF12
Withdrawn
Not reached
Not filled
Not done
Filled
Incomplete
Physicians Villalta – 36 Months
Communication Plan
TRI communicates directly with NCIs (emails and calls)
NCIs also communicate directly with PIs (sites) to keep them engaged and motivated to achieve key
registry milestones
GARFIELD VTE Website
Community Portal Login
Newsletters (Global
Newsletter)
Website Community Portal as a platform for FAQs, Q&A on a
regional and global level.
On a monthly basis
• Reports• Regular
Updates
Data Query Resolution Timeline and Task
Data reviewed and Query Manually raisedEventsPRORecurrent VTEEarly withdrawal formExtra Information
Timeline for Completion December 31st 2017 To resolve all data queries in the Clinpal system
Any Challenges getting queries resolved by end of December 2017?
Tips and suggestions from the team on how they plan to achieve
Investigators, Sub- Investigators and Study Coordinators
Thank You!
Dr Muhammad Hameed
Dr Louis Botha
Dr Shaun Maasdorp
Dr Mohamed Abdool-Gaffar
Dr Abraham Bezuidenhout
Dr Grace Kaye-Eddie
Dr Rapule Ratsela
Dr Dirk Le Roux
Dr Mohamed Khan
Dr Clifford Smith
Dr David Adler
Dr Modise Koto
Dr Nishen Paruk
Prof Barry Jacobson
Discussion
Closing remarks
Rt Hon. Professor the Lord Kakkar PC
