Create the Roles of the users
Administration => Users Management => Group Admin
Creation of the group of users.
First, you must create the different group of users. You will be able to select, depending the created group, to choose if the group will be able to access to a given field of the data entry or not , and If he will be able to write on the field or just read the field .
Management of the group of users
Administration => Users Management => Users Group Admin
In this Menu, you will have the possibility to manage the different actions, a user may have on the case depending the group he belongs to.
Create the Users
Administration => Users Management => Manage Users
Once you created the group of users, you can now create your different users.
We recommend to name you users with real identifiers (such as firstname.lastname) and not to use generic ID
When you create a new user, you will have the possibility to add restrictions to this one:
- Company restriction: the user will only be able to access to the cases for which the company is the same as the restriction.
- Type of report: the user will only be able to access to the cases for which the type of report is the same as the restriction.
- Sponsor study number: the user will only be able to access to the cases for which the sponsor study number is the same as the restriction.
- Product family name: the user will only be able to access to the cases for which the product family name is the same as the restriction.
- Primary source: the user will only be able to access to the cases for which the country of the primary source is the same as the restriction.
- Medicinal product name: the user will only be able to access to the cases for which the medicinal product name is the same as the restriction.
Then create your own product database
Administration => Products Management => Products
Create a product
The product family name is defined as a generic top level name for the product. It is important to attribute this family name regarding query possibilities
Data entry:
The more informations you have entered in the Product creation, the more fields will be automatically be completed.
Import a list of products
You have also the possibility to import an XEVMPD list of products:
- Please, be aware that only XEVMPD containing product validated by the EMA will be imported.
Do not forget: Mandatory to generate E2B Safety Report Ids
Administration => List Management => E2B Sender
E2B sender list defined in this section is used to identify the sender of safety cases.
Information entered here will be used for the xml E2B file generation. It is possible to initiate and/or to modify E2B sender information and then, save modification performed.
Here you can modify settings of the software
Administration => Software’s Management => Settings
- MAH management: Define the case ID used in regulatory reports Case ID
CIOMS Option 1: Define information implemented in the fields "24c" and "26. Remarks" in the CIOMS
Safety report version in E2B messages: No: safety easy version is not displayed in the ICSR/ Yes: safety easy version is displayed in the ICSR
Type of seriousness in Sum Tab: This option is active only for summary tabulation cumulative and PSUR summary tabulation cumulative reports: Case seriousness: count in summary tab will be performed at case level.
Reaction seriousness: count in summary tab will be performed at reaction level.
- Privacy activated: concerns the reporter’s Privacy.
- 2B Patient info Option: To activate the completion of all the fields related to the age (birth date – age – age group). In case of the option isn’t activated the ICSR is completed with the more pertinent information.
- Workflow Option: to choose if the workflow is activated or not.
- Workflow type: Workflow type: Select the reference date for the initial status date
Activate Auto Calculation: When saving the case, calculated fields are completed
- Review name: Allows you to create the name of the case review.
You can decide which fields will appear in your data entry
Administration => Software’s Management => Field Management
This function will allow you to hide the fields that you will not use to make the data entry of a case. To hide the fields, you will not use you will have to tick them and save.
Choose the Duplicate criteria that you want to check
Administration => Software’s Management => Duplicate Management
This function allows you to chose wich will be the fileds you want to check for a duplicate check for the case.
If you need to add rules regarding the reportability
Administration => Products Management => Reportability Matrix
This function allows you to choose in which country your case must be submitted, if the reaction occurred I a given country with a given drug (or all your products).
Once you decided, the “Occurrence country” and the product, you will choose in which country does the case needs to be submited, then decide which report should be send, for which criteria and the deadline (starting from the last receipt date) the case must be submited:
If you need to Manage Clinical Studies
Administration => Clinical studies Management => Clinical Study Information
To create a New study, click on Create New Clinical study. Then you must complete the following fields:
Data entry:
Clinical Arm creation
Administration => Clinical studies Management => Arms
Create new :
By clicking in the blue square button you will have access to the list of your clinical studies, you will have the possibility to select several clinical studies per Arm.
Data entry:
The 3 black buttons are liked to the same list, you can found: Administration => Clinical studies Management => Arms
You need to enter at least one Company name
In Administration => List Management => Company Entities
In this menu, you will be able to create the company names (your company, the company name affiliate…)
Create new :
Data entry :
Please add the assessment sources, methods and results lists
Administration => List Management => Assessment Source
In this menu you will be able to create the sources for the assesment of the reaction.
Data entry:
Administration => List Management => Assessment Method
Here you can create the Assessment method
Data entry:
Administration => List Management => Assessment Result
Here you can create the Assessment result, when you create them, you will have to choose the Reasonable causal relationship: does your value means “yes it is related, or no, it is not related.
Data entry:
If the WorkFlow is activated
Administration => WorkFlow Admin => WorkFlow Status Admin
First: create the WorkFlow statuses. (You can create only one initial and final status, but as many intermediary status as you need).
In the “Max delay Default” you can indicate, in number of days the delay on which the status can stay.
Administration => WorkFlow Admin => WorkFlow Admin
Once the status had been created, you can decide wich group can pass a status to an another status, the delay a case must stay in this status and add conditions for instance, you can pass to the next status if the case is serious and reported by a physician (or medically confirmed).
Administration => WorkFlow Admin => Permit status Admin
Here you will decide, for each group, which actions can be performed on a case depending its status