TRAINING
GENERAL PRESENTATION« NEW » = update of the new version of April
Objectives
Environment
Users & Profiles
Some tips
Support
Practical exercises
trackit
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
Objectives
trackit
Objectives
Environment
Users & Profiles
Some tips
Support
Practical exercises
TRACKIT
SETHI
CIMES
e-CRF
RANDO
IRS
Monitoring
Randomisation listPackaging list
Site creationActors creation (PI, CRA)Patient creation
StudiesOrders
Shipment requests
StockShipment
Shipment requestsReceivingsPatient creationPt Dispensings
ProductionShipment
Electronic case report forms
Randomisation
SupplyingDispensation
CLINTRIAL
Data management
Patient no
Patient noPatient status
Adverse events
TU and DE Tracability
ARGUS
PV
Clinical data
trackit
Objectives
Environment
Users & Profiles
Some tips
Support
Practical exercises
Department
Profile name
Type
Actions in TRACKITMulti-Study
Specific
StudyDI TA Technical
administratorX -
CSCD
FA Functional Administrator
X On each part of the process
CSM Clinical Supply Manager
X xInitializes the study and performs requests (shipment, destruction, relabeling) and orders (TUs & DEs)
TD
SM Study Manager x requests a batch recall
SDM Study Drug Manager xOn DKs & DEs: approves study, validates orders, check the regulatory obligations for shipments from CSU
DDI
CPACChef projet Appui clinique
xApproves orders of TUs & DEsRelabelling actions
SSDM Storage Site Drug Manager
x CSU: manages TUs & DEs on the forward & reverse flows
OC
CDMCountry Drug Manager
xOn country level: initializes a study for storage and dispensing sites and manages the shipment requests of TUs & DEs
SSDM Storage Site Drug Manager
x
On storage site level: manages the shipment and receiving of TUs & DEs on the forward & reverse flows
CRAClinical Research Associate
xCan manage the TUs & DEs in his center: is the only person involved with patients
CSSM (viewer)
x Support for CDM, SSDM and CRA users
AQ Viewer Viewer x -
User profiles and coresponding actions
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
• The CSM of the CSCD is not = Trackit Functional Administration
6. The PMs are declare as CDMs on the study in Trackit by CSM of the
CSCD
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
• Updates of ‘Monitor Responsible’ are not transferred
• FRX users need to be reported in Sethi by internal personnel
• Add the CSSM on the sites for which you need help
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
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.
Don’t mention any letter (exception for UK & NLD)
Don’t 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 !!!
Site View - Delivery Address of dispensation sites (reminder)
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 (if the action is completed)
or, with the principle of « roll back » (if one or more subsequent actions are initialized)
Note: Once a TU dispensed cancelled it will not appear any more on the RDF !!! NEW INFO
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 usedand 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
Remember to click ‘Disconnect’ button to close the program
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
Expired TUs can be dispensed in the July version (there will be a alert notification )
Relabeling and sending actions need to be performed separately
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:
For any account related issue or question regarding virtual machine contact Mrs. Laure Arnaud:
For any tecnical issue, contact Drisse:
trackit
Objectives
Environment
Users & Profiles
Some tips
Support
Practical exercises
Practical exercisesfrom shipment request till destruction action…
Password: ZZDRDTRACKITDomain: FR1
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