ecogen - a short instruction manual.ppt ... · a short instructiona short instruction manual 16th...

Federal Department of the Environment,Transport, Energy and Communications DETEC

Federal Office for the Environment FOENDivision Waste Management, Chemicals and Biotechnology

ECOGENECOGEN -A short instructionA short instruction manualmanual

16th november 2011, Zurich

Advantages of ECOGEN

• Overview of all activities at a glanceOverview of all activities at a glance

• Administrative changes are uncomplicated and g pimmediately done

• Self-management of persons, organisms, locations, notifications etc.

• Status of a notifcation at a glance

2ECOGEN| Short instruction manualGraziella Mazza

ECOGEN – The roles

• Several roles can be allocated to a single person:Several roles can be allocated to a single person:• Member Basic role for having access to

ECOGEN. Members are allowed to fill in a new notification, but they have not the right to submit it electronically to the FCCB.

• BSO Only the persons who are really BSO of a specific organisation have this role and are allowed t b it tifi tito submit notifications.

• Administrator Has the right to create new persons (new accounts) to manage the masterpersons (new accounts), to manage the master data, to do administratives changes…


ECOGEN - Status

• Draft ( deletion is possible)Draft ( deletion is possible)• Ready for completness check (deletion is

possible)p )• Undergoing completness check (active)• Undergoing assessment by authorities (active)U de go g assess e t by aut o t es ( act e)• Complete (active)• Complete and finished (inactive)Complete and finished (inactive)• Replaced (inactive)• Withdrawn (inactive)Withdrawn (inactive)


ECOGEN – The master data

Advantageous to set up g pthe master data before starting a new notification

Especially persons andEspecially persons and locations!


ECOGEN – How to add a new person

AddAdd a new person by clicking on New person“„New person

Edit a person by clicking on the symbol6ECOGEN| Short instruction manual

Graziella Mazza

Edit a person by clicking on the symbol

ECOGEN – How to add a new person

Fill in the administrative information, save and send the password to the new person by choosing one of the four options listed.


ECOGEN – Allocating roles to persons

Several roles can be allocated to a single person TheSeveral roles can be allocated to a single person. The roles are found beneath the person‘s general details (scroll down to bottom and click „Show/hide organisation ( „ gaffiliation“).



Click „New organisational role“. In the screen that appears, select the magnifying glass on the right.

Enter name of organisation, then click „Search“. Select g , „organisation by clicking on the tick.



Allocating roles by clicking on the drop-down menu. Save at the end.


ECOGEN – New notification

To start a new notification click „New tifi ti “notification“.



In the screen that appears, fill in the administrative pp ,information and select the persons. Please note that only persons who are already set up in the master data can be h !choosen!



The next screen shows you the steps you have to followThe next screen shows you the steps you have to follow (steps 1 – 5).


ECOGEN – New notification step 1 enter rooms

Step 1 „Enter rooms“ and then „Enter further rooms“…..



…takes you to this screen. Select organisation by clicking on the tickclicking on the tick.



Fill in the information. Enter rooms for each type of facility.


ECOGEN – New notification step 2 create new organisms

Step 2 „Create organisms“ and then „Add organism to notification“….



….takes you to this screen with search option



If an organims is in one of the official lists, just select the organisms by clicking on the tick.



If an organism is not in one of the official lists, an entry for it can be createdT th f th i i th fi ld (1) dType the name of the organism in the field (1) and click on „Search“(2). After that, click on „create“(3).

(1)(1)

(2) (3)20ECOGEN| Short instruction manual

Graziella Mazza

(2) (3)


N t i t l b t d f ti llNew entries must always be created for genetically modified organisms (GMOs), unless they are already on your private list NOTE: under category“already on your private list. NOTE: under „category , always select GMO, otherwise questions on vectors/plasmids and inserts will not appear.



An appendix must be completed for the following organisms:

•GMOs•Organisms that are not officially classified•Organisms that are not officially classified



Click „Add vector“ or Add i t“ t t„Add insert“ to enter

the corresponding detailsdetails.


ECOGEN – New notification step 2 create viral expression system

Same procedure as for GMOs. Under „category“, always select „viral expression system“, otherwise

ti k i ll li i l tquestions on packaging cell line or viral vector particle will not appear.

(1)(2)(2)

(3) (4)


ECOGEN – New notification step 2 create viral expression systems

Select for each organism the magnifying glass on the right (1). Click on the symbol to add the transduced cell lines (2)transduced cell lines (2).

(1)(2)


ECOGEN – New notification step 3 edit questionnaire

Th ti iThe questionnaire consists of 6 parts General informationGeneral information, Activity (1-3), Risk assessment, Safetyy


ECOGEN – New notification step 3 edit questionnaire

The description of activity should answer the followingshould answer the following question:

- What do I work with?- What do I do with it?


ECOGEN – New notification step 5

Step 5 „Create definitive documents“ takes you to this picture The notification has now the statusthis picture. The notification has now the status „Ready for completeness check“.


ECOGEN – New notification step 5

At this point the notification can be set to draft again Only the click on step 7 Submit foragain. Only the click on step 7 „Submit for completeness check“ sends the notification definitely to the FCCB. y


ECOGEN – Modification of activity

Click on the symbol next to the registration numbernumber ….

d th li k Ch f t t“…and then click on „Change of content“….


ECOGEN – Modification of activity

…which takes you to this screen.The option „Delete notification“ deletes the draft of the modification of activity and not the notification!In this draft you will find all answers of theIn this draft you will find all answers of the previous notification. Just adapt with your new information.information.


ECOGEN – Administratives changes

Click on the symbol next to the registration numbernumber ….

l d i i t ti h ibl…several administratives changes are possible.



In case of a new BSO, new responsible tperson etc.

To fix a time limit (prolongation orTo fix a time limit (prolongation or reduction of time) but also to declare the activity as unlimited.

In case of new locations, new type of f ilitfacility, new rooms…

Click on the tick to declare the activity as terminated.



It is possible to replace a person for several or allIt is possible to replace a person for several or all notifications. Click on ..



Choose the person to be replaced and click onChoose the person to be replaced and click on „Search relevant notifications“.



Select the person to replace with and tick the p pconcerned notifications.


ECOGEN– Use by third parties

What is a use by third parties? This means y pthe notified activity or part of it is being carried out on the premises of external organisational

it T t t lunits. To enter external use:

Click on step 1 „Enter rooms“ (new notification)or on (modification of activity)


ECOGEN– Use by third parties

Enter organisation unit for external use (1). Do not forget to tick „Search all organisations“(2).Click on „Refresh list“ (3). Use the green tick to select the organisation (4).

(3)(1) (2)

(3)

(4)

Once you click on the green tick, the BSO of the external

(4)

y g ,unit will be alerted by email.


ecogen - a short instruction manual.ppt ... · a short instructiona short instruction manual 16th...

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