TRAINING

GENERAL PRESENTATION
NEW = update of the new version of April

trackit
Objectives
Environment
Users & Profiles
Some tips
Support
Practical exercises

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 HAS TO REFLECT REALITY, NO MORE NO LESS

trackit
Objectives
Environment
Users & Profiles
Some tips
Support
Practical exercises

Electronic case report forms

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
Objectives
Environment
Users & Profiles
Some tips
Support
Practical exercises

User profiles and coresponding

actions

Departme
nt
DI

Profile name
TA

On each part of the process

CSM

Clinical Supply
Manager

Initializes the study and performs requests (shipment,

destruction, relabeling) and orders (TUs & DEs)

SM

Study Manager

requests a batch recall

SDM

Study Drug Manager

On DKs & DEs: approves study, validates orders, check the

regulatory obligations for shipments from CSU

CPAC

Chef projet Appui

clinique

SSDM

Storage Site Drug

Manager

CDM

Country Drug
Manager

CSCD

DDI

OC

SSDM
CRA

Storage Site Drug

Manager
Clinical Research
Associate

CSSM

(viewer)
AQ

Actions in TRACKIT

Functional
Administrator

FA

TD

Technical
administrator

Type
Specifi
Multic
Study
Study
X

Viewer Viewer

Approves orders of TUs & DEs

Relabelling actions
x

x
x

CSU: manages TUs & DEs on the forward & reverse flows

On country level: initializes a study for storage and

dispensing sites and manages the shipment requests
of TUs &DEs
On storage site level: manages the shipment and
receiving of TUs & DEs on the forward & reverse flows
Can manage the TUs & DEs in his center: is the only
person involved with patients
Support for CDM, SSDM and CRA users
-

In order to have an active profile within the

Trackit tool:

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)

3. The study is created by the CSM of the CSCD

4. The study is approved by the SDM of the PIT (TRD)
5. The CPIOC provides the CSCD with the list of (ICTR & CRO) PMs in charge
of the trial

Set-up of the study in Trackit by the CDM:

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

Set-up of the study in Trackit by the CRA:

11.The CRA activates the centers.

The Monitor Resp. needs to be declared to activate the site

(the CDM activates the OSDI and destruction sites)
12.The CRA check the following for the activated the centers.

The Monitor Resp. checks the parent site

Set-up of the study in Trackit by the CRA:

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)

Set-up of the study in Trackit by the CRA:

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

Site View - Delivery Address of dispensation sites

(reminder)
Set-up of the study in Trackit by the CRA:

Contact details of the person responsible

for the receiving of the TU/DE =
MANUALLY if other than PI
Enter below also the Delivery address
related to this Contact person.
Think about the entry of the Pharmacy (!)
if applicable
Mandatory field (info provided / entered by CSCD)
- Max. 105 characters / no PO box address !

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)

If changes of the address manually Sethi Trackit interface stopped !!!

trackit
Objectives
Environment
Users & Profiles
Some tips
Support
Practical exercises

Corrections in Trackit

Each user is responsible for the data entered by him/herself

Each user is allowed to correct data under his/her
responsibility
(e.g. the CRA can correct data in his/her own centre)

Corrections can be done for a certain action

directly in the action window

or, after cancelling of the action

or, with the principle of roll back

are initialized)

(if the action is completed)

(if one or more subsequent actions

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

Destruction Authorization (Request)

(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

From parcelling till destruction

(reminder)

Create the outermost container at the dispensation site

Choose the tab Destructions and click New
Select the TUs (and DEs) that you want to parcel
Once the OC created you can Close it
The OC has now a status Parcelled
It is possible to launch the Recovery and destruction form or RDF from here
Create the authorization of destruction (request) at the site where the OC is
stored
Create the OC return at the dispensation site to the storage site
Storage pending on destruction
Return creation at the origin site = dispensation site
Receiving is done at the destination site = interim storage site
Receiving is automatic if the destination site = destruction site or OSDI

From parcelling till destruction

(reminder)

The destruction action (Destruction creation)

Is done at the destruction site
Prior to destruction action is returning to destruction site
The receiving of the return to the destruction site is automatic
At dispensation site -> no return needed : by CRA
Previously : at OSDI -> return to storage OSDI -> return to destruction OSDI on
the same level : by SSDM
Now : at OSDI -> return to storage OSDI -> return to destruction OSDI on the
same level will be automatically duplicated : by SSDM NEW
At destruction site -> return to storage OSDI -> return to destruction site : by
SSDM

Miscellanious

(reminder)

Updates following FONT-CIRT-SOP-82

Regulatory green light ticked by CO CDM locally NEW

Upload of certificate of destruction certificate = mandatory NEW
Upload relabeling protocol = mandatory NEW
Form 21 report of loss of TUs / DEs = mandatory

Updates following FONT-CIRT-SOP 34 ordering

Updates following FONT -CIRT-SOP 40 tracking
Updates following FONT-CIRT-SOP 42 recovery and destruction
Applicable for studies that had no international included patients
before 17/12/2013.

Miscellanious

(reminder)

Ordering: both versions of Shipment request forms available NEW

FONT-CIRT-FORM-37-7.0 & 8.0-EN
Tracking: both versions of TUTF available NEW
FONT-CIRT-FORM-57-1.0 & 1.0-EN (not to be used on site)
Recovery & Destruction: Both versions of RDF & Destr. Auth. Req. available
NEW
Page 1 of RDF: FONT-CIRT-FORM-61-5.0 & 6.0-EN
Page 2 of RDF: FONT-CIRT-FORM-62-4.0 & 5.0-EN
Dest. Auth. Req. FONT-CIRT-FORM-186-3.0 & 4.0-EN
Last step of tracking of non offensive infusions = dispensation NEW
Empty boxes should be tracked and parcelled

trackit
Objectives
Environment
Users & Profiles
Some tips
Support
Practical exercises

eTRACKIT site
eTRACKIT : http://robusta.part.grs.net/rd/e-trackit/

informative Intranet website containing the whole

documentation on Trackit

News & Info on Profiles, Queries, Reports, Forms,

User guide (Practical Forms) ~ WEBSOP
Training material
Subscription for the eLearning

Accessible also by CRO via https://extra.fr.netgrs.com

Sharepoint extranet Portal Avantail

Practical forms

Online Help

Support

For any functional question, contact your CSSM:

marc.meeus@be.netgrs.com

For any account related issue or question regarding virtual

machine contact Mrs. Laure Arnaud:

laure.arnaud@fr.netgrs.com

For any tecnical issue, contact Drisse:

drisse@techteam.com

trackit
Objectives
Environment
Users & Profiles
Some tips
Support
Practical exercises

Practical exercises
from shipment request till destruction action

Training database is available for practice: http

://trackit-for.part.grs.net/
Using Generic users per Profile :
Profile CRA
cbzzdrdtrackitcra / cbzzdrdtrackitcra2 / cbzzdrdtrackitcra8
Profile CDM
cbzzdrdtrackitcdm / cbzzdrdtrackitcdm2 / cbzzdrdtrackitcdm8
Profile SSDM
cbzzdrdtrackitssdm / cbzzdrdtrackitssdm2/ cbzzdrdtrackitssdm3
Password: ZZDRDTRACKIT

Domain: FR1