Manual

Log in

• The Convilance-Cockpit is accessed via the Login screen at cockpit.convilance.com.
• To log in each user has to enter his/her user credentials (e-mail address and password). The username is assigned by the Convilance Team. The password is set by each user individually.
• After logging in the Convilance-Cockpit is shown.

Forgot you password?

• The password can be reset by clicking the blue “Forgot your password?” link below the Log in button.
• By clicking the link, the user is forwarded to a new page where the e-mail address linked to the Convilance-Account has to be entered.
• By clicking “Send password reset link” an e-mail with instructions on how to reset the password will be sent to the entered e-mail address.

Overview

Besides the navigation menu to the left, the Dashboard provides an overview of different message statistics.

• The table at the center of the screen shows all screened online channels.
• You can see the amount of messages received in the current month as well as the amount of messages flagged as relevant (displayed via the exclamation mark).
• The rightmost column of the table shows the timepoint of the last fetch of each channel or whether fetching from a channel is paused.
• Two pie and a bar chart on the right side of the Dashboard provide a graphic display of the message statistics.
  • The pie chart at the top shows last month’s most active channels visualized using differenct colours.
  • The amount of unscreened, flagged and not flagged messages during the last 12 months are shown in the bar chart in the middle.
  • The pie chart at the bottom right of the Dashboard shows the amount of messages with either normal or high relevance received last month.

If there are unscreened messages, they will pop up at the top of the Dashobard with a “Start Screening”-Button for quick access.

• Besides being able to start screening new messages via the Dashboard, it is possible to use the “Start Screening”-Button in the navigation menu to the left to few all unscreened messages.

Quick Screening Function

• Clicking the “Start Screening” at the top of the Dashboard, will allow the user to screen all new messages.
• These messages can be marked as screened (green button) or flagged as relevant (red button).
• When all messages are screened, the user receives a notification.

Flagging A Message

• When flagging a message as relevant it is possible to forward the message to a predefined e-mail address, thereby notifying the compliance/pharmacovigilance department.
• Also an individual internal information can be added to the e-mail for further information/clarity.
• The timestamp of the “Flagging” of the Message will be documented in Convilance for audit- & reporting purposes.

All Messages

• By clicking “All Messages” in the navigation menu to the left all messages/comments of all channels are shown and can be filtered by Date, Status, Channel or Relevance.
• For each message/comment Convilance shows:
  • Channel of the message/comment
  • Time the message was sent/posted
  • User name of the person sending/posting the message/comment

Data Protection

• To comply with the General Data Protection Regulation (GDPR) messages can be anonymized after a defined time span. The corresponding setting can be found in the Organization Settings.
• Anonymized message will still be visible in “All Messages” and the action taken with each message (screening and flagging) will still be show, even after the message has been anonymized.

Message Details

• By clicking on a single message, its details are shown.
• These details feature information on the channel, time point and username.
• Additionally one can see the screening information:
  • the user who screened the message,
  • the time point of its screening/flagging,
  • the reaction time and
  • whether it is relevant for PV or not is displayed.

Reporting

• Under the menu point “Reporting” the monthly overview report can be found.
• It provides detailed insights into each day of a month, including screenings and reaction times.
• On the top left the respective month for the report can be changed.
• By clicking on a specific date all messages received and the actions taken with these messages are displayed.

Audit Trail

• Convilance documents all monitoring activities, notifications and screenings activities in a permanent audit trail.
• This feature can be found under the menu point “Audit Trail”. Three different kinds of Audit Trails are available.
  • Screenings
  • Fetches
  • E-Mails

Sreenings
Provides an Audit Trail of all screened messages and whether they were flagged for PV or not.

Fetches
Provides a summary of all Fetches conducted by Convilance, the amount of messages received on each channel and whether there were new messages at the timepoint of the fetch. Convilance also displays if errors occured during a fetch.

E-mails
Provides documentation of all e-mails sent by Convilance.

Personal information anonymization

• All messages can be automatically anonymized after a certain time period, this setting is used to specify the time for both flagged and unflagged messages.
• This setting is especially useful for GDPR compliance (Note: You should not store personal information of messages that do not contain any adverse reaction reports for longer than necessary.)
• Anonymization will remove all personal information like message content and user names, but will keep anonymous information like channel, date and screening result for reporting purposes.

Important: Once a message has been anonymized it is impossible to recover the removed information.

Forwarding of flagged messages

• This setting is used to provide a dedicated e-mail adress which shall be notified when a message has been flagged as relevanted for PV/PMS.
• Messages that have been screened and flagged will be forwarded to this e-mail address.
• This is especially useful to automatically notify the pharmacovigilance/patient safety/compliance department about messages with possible adverse reactions.

Relevance Calculation

• Convilance will automatically determine if a message has a normal, lower, or higher probability to contain relevant information.
• This is calculated by a set of deterministic rules that can be configured using significant keywords, negligable keywords and/or the length of messages.
• Convilance provides users with a list of general medical terms, which can be personalised to include company specific products, active ingredients and so on.
• Thereby Convilance will be trained to provide you with high priority e-mails as soon as it detects certain keywords.

Important: Please note that changes to these relevance settings will automatically re-calculate the relevance for all messages on all channels to reflect the updated settings.

Special Authors

• To ensure that your own messages are not qualified as high relevance, authors can be added to this box.
• When adding multiple authors make sure to separate them with a comma or write them in a new line.
• There are four different settings to define the relevance of your own messages.

Daily Summary E-Mails

• The interval as well as the time of day at which the daily e-mails shall be received can be adjusted.
• The intervals for receiving an e-mail can vary from:
  • every day
  • every day but only if there are unscreeened messages
  • every day but only if there are new messages to
  • never.

High Relevance E-Mails

• In addition to the daily summary e-mails you can choose to receive priority e-mails.
• These e-mails will be sent to your e-mail account immediately after Convilance detects a message with high relevance.
• High relevance is calculated by a set of deterministic rules that can be configured using keywords to include general medical terms, specific products or active ingredients.

Substitution Rules

• Substitution rules can be defined by setting different intervals for notification mails for different users.
• For example:
  • The employee mainly responsible for screening messages will receive daily notification mails.
  • In case of sick leave or holiday a second employee, acting as his/her substitute, will receive a notification e-mail if there are unscreened messages. Meaning he/she will only reveice an e-mail when the employee mainly responsible for screening is absent or forgets to screen certain messages.

Authorizations

• This menu point provides the user with a view of all connected channels which Convilance uses to fetch comments/messages.
• Some channels require manual authorization to access comments/messages. Access to these channels must be authorized by a user with administrator rights.