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GENERAL PRESENTATION
NEW = update of the new version of April
trackit
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Environment
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Objectives
To allow the tracking of TU used in clinical studies (release
destruction)
To ensure the DE tracking (decoding envelops, decoding lists)
To allow a quick and efficient batch recall of TU worldwide
To be in accordance with the GMP & GCP regulations
To be inspected by the Authorities
One tool & unique information, to homogenize the information systems,
minimize data capture errors, and have access to reliable and shared
information, at any time
trackit
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Monitoring
SETHI
Patient no
Patient status
Data management
Clinical data
e-CRF
CLINTRIAL
Adverse events
Patient no
ARGUS
Site creation
Actors creation (PI, CRA)
Patient creation
PV
Supplying
Dispensation
IRS
Shipment requests
Receivings
Patient creation
Pt Dispensings
TRACKIT
TU and DE Tracability
Studies
Orders
Shipment requests
Stock
Shipment
CIMES
Production
Shipment
Randomisation list
Packaging list
RANDO
Randomisation
trackit
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Environment
Users & Profiles
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Departme
nt
DI
Profile name
TA
CSM
Clinical Supply
Manager
SM
Study Manager
SDM
CPAC
SSDM
CDM
Country Drug
Manager
CSCD
DDI
OC
SSDM
CRA
CSSM
(viewer)
AQ
Actions in TRACKIT
Functional
Administrator
FA
TD
Technical
administrator
Type
Specifi
Multic
Study
Study
X
Viewer Viewer
x
x
CSU: manages TUs & DEs on the forward & reverse flows
1. The user needs to pass the Trackit e-learn with score > 70%
2. The user forwards a print screen of the score page to Marc Meeus who
requests the account
For the moment external user can not be invited to the e-learn
(waiting for global decision)
7. The CDM checks if the centers are created (automatic transfer through
Sethi Trackit interface)
8. The CDM creates the OSDI and the destruction site manually (if
applicable).
9. The CDM declares him/herself as SSDM of an OSDI or destruction site (if
applicable).
10.The CDM checks if the CRA is declared on the centers (automatic
through Sethi Trackit interface).
The center will migrate even if there is no Monitor Resp. declared
in Sethi NEW
12.The CRA check the following for the activated the centers.
The Monitor Resp. checks if the regulatory tick box is ticked to
allow the creation of shipment requests
(The CDM does the same for the OSDI when applicable)
(The ticking of the export tick box at OSDI site view allows the
shipment request creation although the regulatory obligations are
not fulfilled. This is useful to anticipate order = pre-parceling)
12.The CRA check the following for the activated the centers.
The Monitor Resp. checks the site contact information
o Fill in the contact information manually if other than PI
(pharmacist or other )
o Check the contact information
o Check if the client number is reported
o If the contact information is not available from the drop
down list contact the CSM of the CSCD
(The CDM does the same for the OSDI when applicable)
13.The site can now be activated in IRS
MANUALLY
- Organiz., Dept, exact location if applic., Street &
no.
Dont mention any letter (exception for UK & NLD)
Dont mention any Country in the City field
(separate Country field)
Address field = 105 char. max. (jump of line = 1 char.; string - = 1 char; repetitive or Tabs = 1 char) in TRACKIT but NOT in
SETHI
Due to limited possibilities of the tool used by CHRONOPOST & the implementation of CIMES
Concerned : Sites for which TU Shipment is done directly from CSU
If no ZIP code put NA (for Jordan for example)
trackit
Objectives
Environment
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Corrections in Trackit
Some Tips
To connect to TRACKIT, use your Windows login, password and
Domain
Need of Internet explorer browser of version 8 (at least) (Ok for
VM 4)
On Site : If no technical limits on the Site, TRACKIT can be used
and RDFs can be launched (via VPN connection)
RDFs from TRACKIT are to be used mandatory >< TUTFs from
TRACKIT are forbidden on site
Do not forget to use the zoom level internet explorer or
control + mouse wheel to display the whole page
(reminder)
Previously
After the return of parcelled OC
The destruction authorization request was done on the destination site
Issue
Done at the level where the OC is stored (before sending for destruction)
The CRA could not access the OSDI or destruction site
The SSDM needed to print the destruction authorization request for CRA
Solution NEW
The destruction authorization request is created as well as the form on the origin site
It is done by the person who did the parcelling
By the CRA at the dispensation site
By SSDM at the OSDI
RDF the old and RDF the new version (following FONT-CIRT-SOP- 42) are available
(reminder)
(reminder)
Miscellanious
(reminder)
Miscellanious
(reminder)
trackit
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eTRACKIT site
eTRACKIT : http://robusta.part.grs.net/rd/e-trackit/
Practical forms
Online Help
Support
laure.arnaud@fr.netgrs.com
trackit
Objectives
Environment
Users & Profiles
Some tips
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Practical exercises
from shipment request till destruction action
Domain: FR1