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:

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 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